Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

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OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Ripretinib

(rih-PREH-tih-nib)

Ripretinib (Qinlock™) is used for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Ripretinib (Qinlock™) is used for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

Page 1 RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ripretinib (rih PREH tih nib) Brand name — Qinlock™ (KIN lok) Approved uses Ripretinib is used for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Dose and schedule Taking ripretinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of ripretinib is 150 milligrams (150 mg) to be taken by mouth at a scheduled time once a day. Ripretinib can be taken with or without food, but should be taken at the same time each day. Ripretinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ripretinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ripretinib, follow these guidelines: • Only take the missed dose if it has been less than 8 hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Ripretinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with ripretinib; avoid eating or drinking these during treatment with ripretinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle ripretinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store ripretinib at room temperature (68°F–77°F) in a dry location away from light. Ripretinib comes with a desiccant packet in the bottle to protect your medicine from moisture. Do not remove the desiccant packet from the bottle. Keep ripretinib out of reach of children and pets. Leave ripretinib in the provided packaging until it is ready to be taken. RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Whenever possible, you should give ripretinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ripretinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the ripretinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with ripretinib. If you have any unused ripretinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of ripretinib. If you are traveling, put your ripretinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Ripretinib Below are common side effects that have been known to happen in about one third or more of patients taking ripretinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Continued on the next page RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Increased activated partial thromboplastin time (aPTT) and/ or international normalized ratio (INR), measures of how long it takes for your blood to clot It could take longer for your blood to clot, meaning that it could be easier for you to bruise or bleed. Report any unusual bruising or bleeding to your provider. Constipation Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Stay active and exercise, if possible. • Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate (Colace®) and/or a laxative such as senna (Senakot®) may be helpful. If these do not help within 48 hours, tell your provider. Continued on the next page RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Muscle or joint pain or weakness • Keep a diary of your pain or weakness, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Increase in your serum lipase, an enzyme made by your pancreas Let your provider know if you start to experience nausea and/or vomiting with abdominal pain, as these could be signs of changes in the function of your pancreas Pain or discomfort on hands and/or feet Hand and foot syndrome (HFS) is a skin reaction that appears on the palms of the hands and the soles of the feet. It can appear as a rash, peeling skin, or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFS, you can do the following: • Keep hands and feet moisturized. • Avoid hot showers or baths that may dry out the skin. • Avoid tight shoes or socks. Continued on the next page Serious side effects Ripretinib can cause new primary skin cancers. Notify your care team if you notice any changes in your skin or new skin lesions. Ripretinib can cause increased blood pressure. Notify your care team if you develop symptoms such as headache, dizziness, chest pain, shortness of breath, or fluid retention/weight gain/swelling. Ripretinib can cause a decrease in heart function or cardiomyopathy. Notify your care team if you are having shortness of breath or chest pain. Ripretinib can cause wound healing problems. Notify your care team if you have a wound that doesn’t heal properly. Also tell your care team if you have a planned surgery or dental procedure, as ripretinib should be stopped prior to your surgery. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Handling body fluids and waste Since ripretinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take ripretinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ripretinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking ripretinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of ripretinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking ripretinib and for 1 week after the last dose of ripretinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ripretinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) RIPRETINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: https://www.qinlock.com/ Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2020/213973s000lbl.pdf Product resources: https://www.decipheraaccesspoint.com Updated – May 22, 2020 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rozlytrek®

(roz-LY-trek)

Rozlytrek® (Entrectinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a mutation of the ROS-1 gene, as well as to treat cancers that have a neutrophic tyrosine kinase (NTRK) gene mutation.

Rozlytrek® (Entrectinib) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a mutation of the ROS-1 gene, as well as to treat cancers that have a neutrophic tyrosine kinase (NTRK) gene mutation.

Page 1 ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name entrectinib (en TREK tih nib) Brand name Rozlytrek® (roz LY trek) Approved uses Entrectinib is used to treat metastatic non small cell lung cancer (NSCLC) that has a mutation of the ROS 1 gene, as well as to treat cancers that have a neutrophic tyrosine kinase (NTRK) gene mutation. Dose and schedule Taking entrectinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual adult dose of entrectinib is 600 milligrams (600 mg) to be taken by mouth at a scheduled time once a day. Entrectinib can be taken with or without food, but at the same time each day. Entrectinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow entrectinib, talk to your care provider or pharmacist for possible options. If you miss a dose of entrectinib, take it as soon as you remember. If your next dose is due within 12 hours, skip the missed dose. Do not take an extra dose or two doses at one time. Drug and food interactions Entrectinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with entrectinib; avoid eating or drinking this during treatment with entrectinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle entrectinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store entrectinib at room temperature (68°F–77°F) in a dry location away from light. Keep entrectinib out of reach of children and pets. Leave entrectinib in the provided packaging until it is ready to be taken. Whenever possible, you should give entrectinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the entrectinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the entrectinib from its package to a small medicine or other disposable cup. ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, contact your care team before using. The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. Side Effects of Entrectinib Below are common side effects that have been known to happen in about one third or more of patients taking entrectinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Unusual swelling in your legs and feet Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Changes in electrolytes and other laboratory values High uric acid levels High sodium levels High calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs and feet Red or brown colored urine Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating cars or machinery if you feel too tired. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Stay active and exercise, if possible. Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate (Colace®) and/or a laxative such as senna (Senakot®) may be helpful. If these do not help within 48 hours, tell your provider. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Continued on the next page ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following. Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Dizziness You may notice a lightheaded, weak, or unsteady feeling while you are on this medication. Use caution when driving and operating machinery. Let your provider know if this feeling occurs. Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help with the nausea or vomiting. Pain Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed too. Tell your care provider if pain interferes with your activity. If the pain bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Cough or shortness of breath A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. Serious side effects Birth defects: Entrectinib can cause serious birth defects. Do not take entrectinib if you are pregnant or think you might be pregnant. Heart failure: Entrectinib can cause heart failure. Contact your care team right away if you are having any swelling or shortness of breath. Central nervous system (CNS) side effects: Entrectinib may cause dizziness, changes in your mood, or confusion, hallucinations, problems with concentration, attention, memory, and sleep, and it may affect how you think. Speak with your care team if you notice any of these symptoms. Bone fractures: Entrectinib can cause bones and muscles to weaken and may increase your risk for falls and broken bones. Your doctor may prescribe a medication to decrease your risk of broken bones. QT prolongation: Entrectinib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be lifethreatening. Tell your care team right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast while taking entrectinib. ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Vision problems: Entrectinib may cause changes to your vision. Tell your care team right away if you have any loss of vision or changes in your eyesight, such as double vision, blurry vision, new or increased floaters, seeing flashes of light, or light hurting your eyes. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since entrectinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take entrectinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or entrectinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking entrectinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of 5 weeks after the last dose of entrectinib. Men who have female partners who can become pregnant should use effective contraception during therapy and for a minimum of 3 months after the last dose of entrectinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking entrectinib and for 7 days after the last dose of entrectinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. ENTRECTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Obtaining medication Talk with your care provider about the process for obtaining your entrectinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.rozlytrek.com Product prescribing information: https://www.gene.com/download/pdf/rozlytrek prescribing.pdf Updated – October 23, 2019 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rubraca®

(roo-BRAH-kuh)

Rubraca® (Rucaparib) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Rubraca® (Rucaparib) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Page 1 RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — rucaparib roo-KA-puh-rib Brand name — Rubraca® roo-BRAH-kuh Approved uses Rucaparib is used to treat ovarian cancer in women who have a genetic mutation called BRCA. Dose and schedule Taking rucaparib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of rucaparib is 600 milligrams 600 mg to be taken by mouth at a scheduled time twice a day. Rucaparib may be taken with or without food, but at the same time each day. Rucaparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow rucaparib, talk to your care provider or pharmacist for possible options. If you miss a dose of rucaparib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle rucaparib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store rucaparib at room temperature 68°F–77°F in a dry location away from light. Keep rucaparib out of reach of children and pets. Leave rucaparib in the provided packaging until it is ready to be taken. Whenever possible, you should give rucaparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the rucaparib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the rucaparib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for rucaparib. Do not mix other medications into the box with rucaparib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused rucaparib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of rucaparib. If you are traveling, put your rucaparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since rucaparib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take rucaparib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or rucaparib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Rucaparib has many drug interactions. Please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Rucaparib The common side effects that have been known to happen in more than 30% of patients taking rucaparib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8-10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low-fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high-fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose-containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day, unless your care provider has instructed you to limit your fluid intake because of some other health problem. Stay active and exercise, if possible. Eat foods high in fiber, like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over-the-counter medications to help with your constipation. A daily stool softener, such as docusate Colace® , and/or a laxative, such as senna Senokot® , may be helpful. If these do not help within 48 hours, tell your provider. Changes in laboratory values high calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased appetite or weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 7 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking rucaparib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of rucaparib. Do not breastfeed while taking rucaparib and for two weeks after the last dose of rucaparib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on rucaparib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your rucaparib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: www.rubraca.com Product prescribing information: clovisoncology.com/files/rubraca-prescribing-info.pdf Product resources: www.rubraca.com/support-resources Updated – August 14, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rucaparib

(roo-KA-puh-rib)

Rucaparib (Rubraca®) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Rucaparib (Rubraca®) is used to treat ovarian cancer in women who have a genetic mutation called BRCA.

Page 1 RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — rucaparib roo-KA-puh-rib Brand name — Rubraca® roo-BRAH-kuh Approved uses Rucaparib is used to treat ovarian cancer in women who have a genetic mutation called BRCA. Dose and schedule Taking rucaparib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of rucaparib is 600 milligrams 600 mg to be taken by mouth at a scheduled time twice a day. Rucaparib may be taken with or without food, but at the same time each day. Rucaparib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow rucaparib, talk to your care provider or pharmacist for possible options. If you miss a dose of rucaparib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle rucaparib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store rucaparib at room temperature 68°F–77°F in a dry location away from light. Keep rucaparib out of reach of children and pets. Leave rucaparib in the provided packaging until it is ready to be taken. Whenever possible, you should give rucaparib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the rucaparib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the rucaparib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for rucaparib. Do not mix other medications into the box with rucaparib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused rucaparib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of rucaparib. If you are traveling, put your rucaparib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since rucaparib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take rucaparib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or rucaparib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Rucaparib has many drug interactions. Please inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Rucaparib The common side effects that have been known to happen in more than 30% of patients taking rucaparib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney renal function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed, too. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8-10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low-fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high-fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose-containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day, unless your care provider has instructed you to limit your fluid intake because of some other health problem. Stay active and exercise, if possible. Eat foods high in fiber, like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over-the-counter medications to help with your constipation. A daily stool softener, such as docusate Colace® , and/or a laxative, such as senna Senokot® , may be helpful. If these do not help within 48 hours, tell your provider. Changes in laboratory values high calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Continued on the next page RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased appetite or weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small frequent meals instead of three large meals each day. Keep snacks nearby so you can eat when you feel hungry. Take liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth before and after eating with a soft bristle toothbrush. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 7 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking rucaparib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of six months after the last dose of rucaparib. Do not breastfeed while taking rucaparib and for two weeks after the last dose of rucaparib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on rucaparib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your rucaparib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUCAPARIB ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: www.rubraca.com Product prescribing information: clovisoncology.com/files/rubraca-prescribing-info.pdf Product resources: www.rubraca.com/support-resources Updated – August 14, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy-to-understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Ruxolitinib

(RUK-soh-LI-ti-nib)

Ruxolitinib (Jakafi®) is used to treat patients with myelofibrosis and polycythemia vera.

Ruxolitinib (Jakafi®) is used to treat patients with myelofibrosis and polycythemia vera.

Page 1 RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Ruxolitinib RUK soh LI ti nib Brand name — Jakafi® JA kah fy Approved uses Ruxolitinib is used to treat patients with myelofibrosis and polycythemia vera. Dose and schedule Taking ruxolitinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of ruxolitinib is 5 milligrams 5 mg to 25 milligrams 25 mg to be taken by mouth at a scheduled time twice a day. Ruxolitinib can be taken with or without food but at the same time each day. Ruxolitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ruxolitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ruxolitinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Storage and handling Handle ruxolitinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store ruxolitinib at room temperature 68°F–77°F in a dry location away from light. Keep ruxolitinib out of reach of children and pets. Leaving ruxolitinib in the original packaging is preferred. Whenever possible, give ruxolitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ruxolitinib to you, they may also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the ruxolitinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for ruxolitinib. Do not mix other medications into the box with ruxolitinib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused ruxolitinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of ruxolitinib. If you are traveling, put your ruxolitinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because ruxolitinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take ruxolitinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or ruxolitinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Ruxolitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with ruxolitinib; avoid eating or drinking these during your treatment with ruxolitinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ruxolitinib The common side effects that have been known to happen in more than 30% of patients taking ruxolitinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolytes and other laboratory values High cholesterol levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling in your legs or feet Red or brown colored urine If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking ruxolitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of ruxolitinib. Do not breastfeed while taking ruxolitinib and for two weeks after the last dose of ruxolitinib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on ruxolitinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ruxolitinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO RUXOLITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Additional resources Product website: www.jakafi.com Product prescribing information: www..jakafi.com/pdf/prescribing information.pdf Product resources: www.jakafi.com/support and resources.aspx Updated — July 11, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Rydapt®

(RY-dapt)

Rydapt® (Midostaurin) is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders.

Rydapt® (Midostaurin) is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders.

Page 1 MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — midostaurin MY doh STAW rin Brand name — Rydapt® RY dapt Approved uses Midostaurin is used to treat adult patients with a type of acute myeloid leukemia, and other blood cell disorders. Dose and schedule Taking midostaurin as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of midostaurin is 50 milligrams 50 mg or 100 mg to be taken by mouth at a scheduled time twice a day. Midostaurin should be taken with food at the same time each day. Midostaurin should be taken whole and not opened, crushed, cut, or dissolved. If you are unable to swallow midostaurin, talk to your care provider or pharmacist for possible options. If you miss a dose of midostaurin, do not take an extra dose or two doses at one time. Simply take the next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle midostaurin with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store midostaurin at room temperature 68°F–77°F in a dry location away from light. Keep midostaurin out of reach of children and pets. Leave midostaurin in the provided packaging until it is ready to be taken. Whenever possible, give midostaurin to yourself and follow the steps below. If a family member, friend, or caregiver needs to give midostaurin to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the midostaurin from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with midostaurin. MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 2 If you have any unused midostaurin, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of midostaurin. If you are traveling, put your midostaurin in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since midostaurin remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take midostaurin, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or midostaurin with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Midostaurin has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with midostaurin; avoid eating or drinking these during treatment with midostaurin. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Midostaurin The common side effects that have been known to happen in more than 30% of patients taking midostaurin are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk for having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore or scratchy throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for fever or chills. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolytes and other laboratory values High glucose levels Low calcium levels High lipase levels High uric acid levels Low sodium levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Mouth irritation or sores Practice good mouth care. Rinse your mouth frequently. Brush your teeth with a soft toothbrush or cotton swab after meals. Use a mild nonalcohol mouth rinse at least four times a day after eating and at bedtime . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache: Follows a head injury Is severe, especially if it starts suddenly Does not go away after three days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, made worse by coughing or lowering the head, rash, weakness in an arm or leg, or numbness Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week Continued on the next page MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 7 Possible Side Effect Management Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Muscle or joint pain Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed, too. Tell your care provider if pain or a spasm interferes with your activity. If the pain bothers you, ask your provider what you may use to help with this discomfort. Take pain medication only that has been prescribed or recommended by your care provider. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking midostaurin. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of midostaurin. Do not breastfeed while taking midostaurin and for four months after the last dose of midostaurin. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on midostaurin, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about how to obtain your midostaurin. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO MIDOSTAURIN ORAL CHEMOTHERAPY EDUCATION Page 8 Additional resources Product website: https://www.us.rydapt.com Product prescribing information: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/ files/rydapt.pdf Product resources: https://www.us.rydapt.com/interested in/patient support Updated — September 8, 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Selinexor

Selinexor (Xpovio®) is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone.

Selinexor (Xpovio®) is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone.

Page 1 SELINEXOR ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name Selinexor Brand name Xpovio® (x PO Vee O) Approved uses Selinexor is used to treat multiple myeloma (MM) and is used in combination with another medication, dexamethasone. Dose and schedule Taking selinexor as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of selinexor is 80 milligrams (80 mg) to be taken by mouth on days 1 and 3 of each week. Selinexor can be taken with or without food, but at the same time each day. Selinexor should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow selinexor, talk to your care provider or pharmacist for possible options. If you miss or vomit a dose of selinexor, follow these guidelines: Do not take an extra dose or 2 doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Selinexor has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with selinexor; avoid eating or drinking this during treatment with selinexor. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle selinexor with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store selinexor at room temperature (68°F–77°F) in a dry location away from light. Keep selinexor out of reach of children and pets. Leave selinexor in the provided packaging until it is ready to be taken. Whenever possible, you should give selinexor to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the selinexor to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the selinexor from its package to a small medicine or other disposable cup. SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box is not recommended to be used with selinexor. If you have any unused selinexor, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of selinexor. If you are traveling, put your selinexor’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selinexor Below are common side effects that have been known to happen in about one third or more of patients taking selinexor; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, notice blood in your urine or stool, cough up blood, or have prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: Eat small, frequent meals rather than 3 large meals each day. Keep snacks nearby so you can eat when you feel hungry. Drink liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Changes in electrolytes and other laboratory values Low sodium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs and feet Red or brown colored urine Continued on the next page SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Serious side effects Selinexor can cause serious birth defects. Do not take selinexor if you are pregnant or think you might be pregnant. Selinexor can cause neurologic side effects, like dizziness, fainting, decreased alertness, and changes in your mental status, including confusion and decreased awareness of things around you (delirium). These problems can sometimes be severe. Tell your care team right away if you notice any of these signs or symptoms. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selinexor remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take selinexor, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 6 If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or selinexor with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking selinexor. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of selinexor. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking selinexor and for 1 week after the last dose of selinexor. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your selinexor. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212306s000lbl.pdf Updated – July 29, 2019 Additional instructions SELINEXOR ORAL CHEMOTHERAPY EDUCATION Page 7 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Selpercatinib

(SEL-per-KA-tih-nib)

Selpercatinib (Retevmo™) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in the RET protein.

Selpercatinib (Retevmo™) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in ...

Page 1 SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — selpercatinib (SEL per KA tih nib) Brand name — Retevmo™ (reh TEV moh) Approved uses Selpercatinib is used to treat non small cell lung cancer (NSCLC) that has a genetic mutation called RET fusion. Selpercatinib is used to treat thyroid cancer that has a genetic mutation or fusion in the RET protein. Dose and schedule Taking selpercatinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of selpercatinib is between 120 milligrams (120 mg) and 160 mg to be taken by mouth at a scheduled time twice a day. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Selpercatinib can be taken with or without food, but at the same time each day. Selpercatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow selpercatinib, talk to your care provider or pharmacist for possible options. If you vomit a dose of selpercatinib, do not take another dose. Wait until your next scheduled dose. If you miss a dose of selpercatinib, follow these guidelines: • Do not take the missed dose unless it is more than 6 hours until your next scheduled dose. Simply take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Selpercatinib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with selpercatinib; avoid eating or drinking these during treatment with selpercatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle selpercatinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store selpercatinib at room temperature (68°F–77°F) in a dry location away from light. Keep selpercatinib out of reach of children and pets. Leave selpercatinib in the provided packaging until it is ready to be taken. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Whenever possible, you should give selpercatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the selpercatinib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the selpercatinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder will be used, contact your care team before using. • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused selpercatinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of selpercatinib. If you are traveling, put your selpercatinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selpercatinib Below are common side effects that have been known to happen in about one third or more of patients taking selpercatinib; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Continued on the next page SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Changes in electrolytes and other laboratory values including • Low calcium levels • High glucose levels • Low albumin levels Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Mouth irritation or sores or dry mouth Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild non alcohol mouth rinse at least 4 times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Decreased amount of urination • Unusual swelling in your legs and feet Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary, and report your findings to your physician. Contact your healthcare provider for high blood pressure or if symptoms such as the following occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Continued on the next page SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Fluid retention or swelling • Do not stand for long periods of time. • Keep your legs elevated when sitting or lying down. • Avoid eating salty foods, which can increase swelling. • Avoid wearing tight fitting clothing and shoes. • Weigh yourself daily. Contact your care provider if you notice the following: • Swelling in the hands, feet, or legs • Shortness of breath • Weight gain of 5 pounds or more in a week Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Increased cholesterol levels Changes in cholesterol may occur and will be monitored by a simple blood test. You may not feel any symptoms if changes occur. Your care team will monitor for this. Serious side effects Selpercatinib may be harmful to your liver. Seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. You may have high blood pressure while taking selpercatinib. Take your blood pressure on a regular basis, and let your care team know of any large increases in blood pressure. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Selpercatinib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life threatening. Tell your care team right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking selpercatinib. You may be at a higher risk of bleeding while taking selpercatinib. Contact your care team if you notice frequent nose bleeds, blood in your stool, bleeding that occurs by itself without injury, or bleeding that will not stop after 5 minutes of pressure. Severe allergic reactions are a rare but serious side effect of selpercatinib. Immediately seek medical attention if you notice difficulty breathing, swelling of the mouth or tongue, or a serious rash. Selpercatinib can cause cuts or wounds to heal more slowly. Tell your care team if you have a wound that doesn’t heal properly. Also tell your care team if you have a planned surgery or dental procedure, as selpercatinib should be stopped prior to your surgery. Your doctor may restart selpercatinib after your surgical wound has healed. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selpercatinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take selpercatinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or selpercatinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking selpercatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of selpercatinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. SELPERCATINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Do not breastfeed while taking selpercatinib and for 1 week after the last dose of selpercatinib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your selpercatinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.retevmo.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2020/213246s000lbl.pdf Product resources: https://www.retevmo.com/?section=savings support Updated – May 27, 2020 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Selumetinib

(SEL-yoo-MEH-tih-nib)

Selumetinib (Koselugo™) is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery.

Selumetinib (Koselugo™) is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery.

Page 1 SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — selumetinib (SEL yoo MEH tih nib) Brand name — Koselugo™ (koh SEL yoo goh) Approved uses Selumetinib is used for pediatric patients (2 years of age or older) to treat neurofibromatosis type (NF1) with plexiform neurofibromas that cannot be removed by surgery. Dose and schedule Taking selumetinib as instructed is important to allow your child’s treatment to be as effective as possible, so here are some key points to remember. Your child’s dose is based on many factors, including their height and weight, overall health, and diagnosis. Selumetinib should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal or snack). Selumetinib should be taken whole and not crushed, cut, or dissolved. If your child is unable to swallow selumetinib, talk to your child’s care provider or pharmacist for possible options. If your child misses a dose of selumetinib, follow these guidelines: • Do not have your child take the missed dose if it is less than 6 hours until their next scheduled dose. Simply have your child take the next dose at the regularly scheduled time. • Do not have your child take two doses at one time. • Be sure to write down if your child misses a dose, and let your care provider know about any missed doses. Drug and food interactions Selumetinib has many drug interactions. Please inform your child’s care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with selumetinib; have your child avoid eating or drinking these during treatment with selumetinib. Selumetinib should be taken on an empty stomach (at least 1 hour before or 2 hours after a meal or snack). Talk with your child’s care provider or pharmacist before your child takes new medications or supplements or receives any vaccines. Selumetinib capsules contain vitamin E. Excessive intake of vitamin E may increase your child’s risk of bleeding. Talk with your child’s healthcare provider before giving your child any supplements with vitamin E. Storage and handling Handle selumetinib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Store selumetinib at room temperature (68°F–77°F) in a dry location away from light. Keep selumetinib out of reach of pets or other children. Leave selumetinib in the provided packaging until it is ready to be taken. When you, a family member, a friend, or a caregiver needs to give the selumetinib to your child, these steps should be followed: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. 3. Gently transfer the selumetinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with selumetinib. If you have any unused selumetinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of selumetinib. If you are traveling, put your selumetinib’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Selumetinib Below are common side effects that have been known to happen in about one third or more of patients taking selumetinib; these are listed on the left side of this table. Your child MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If your child experiences any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if your child experiences nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Rash/dry skin/itching If your child gets dry or itchy skin while taking selumetinib, • Keep your child’s skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. If your child gets a rash that looks like acne on their face, chest, and upper back while taking selumetinib, • Your doctor may prescribe medication to help prevent or manage the rash. • If they do get a rash, keep the area around the rash clean and dry. • Check with your care provider before using anything to treat it. • Do not use over the counter acne treatments, such as benzoyl peroxide or salicylic acid or soaps containing alcohol. • Oatmeal baths and unscented moisturizers may help with itching. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am–4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on the bottle. • Use lip balm with at least SPF 30. If your child’s rash or itching continues to worsen, contact your care provider. Changes in electrolytes and other laboratory values including • Increased creatine phosphokinase • Decreased albumin • Increased lipase Changes in some laboratory values may occur and will be monitored by a simple blood test. • Your child may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if they have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of the legs or feet • Red or brown colored urine Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements your child has each day. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: • The number of bowel movements your child has in a day increases by 4 or more. • They feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your child’s diarrhea, but talk to your care provider before starting this medication. Stomatitis Practice good mouth care. • Rinse your child’s mouth frequently. • Brush your child’s teeth with a soft toothbrush or cotton swab after meals. • Use a mild non alcohol mouth rinse at least 4 times a day (after eating and at bedtime). One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If your child has sores in their mouth, avoid using mouthwashes that contain alcohol. Call your care provider if your child experiences pain or sores in their mouth or throat. Muscle or joint pain or weakness • Keep a diary of your child’s pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Have your child stay as active as possible, but know that it is okay to rest as needed. • Tell your care provider if pain interferes with their activity. If the pain or weakness bothers them, ask your provider what you may use to help with this discomfort. Use only pain medication that has been prescribed or recommended by your care provider. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Fatigue Your child may be more tired than usual or have less energy. • Have them stay as active as possible, but know it is okay to rest as needed. • Try to have them do some activity every day. • Plan their activities, and have them do them at a time of day when they feel a bit more energetic. Pyrexia Your child may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if they have a fever of 100.4°F. Ask your doctor if they can take medicine to help with the fever. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your child’s headache has any of the following characteristics: • Follows a head injury • Is severe or starts suddenly • Does not go away after 3 days • Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, rash, weakness in an arm or leg, or numbness; or is made worse by coughing or lowering the head Nail changes (paronchyia) Usually, this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, and picking at the nails can increase the risk of getting an infection. • Talk to your care provider if you notice any changes in your child’s nails. Changes in liver function Your child’s liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of their eyes • Dark or brown urine • Bleeding or bruising Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased hemoglobin, the part of the red blood cells that carries iron and oxygen Your child’s hemoglobin should be monitored by a simple blood test. When their hemoglobin is low, you may notice that they get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that your child becomes more pale than usual. Let your care provider know right away if they experience any of the following: • Shortness of breath • Dizziness • Palpitations Constipation Monitor how many bowel movements your child has each day. • Ensure that your child is drinking water or fluid each day unless your care provider has instructed you to limit your child’s fluid intake. Contact your care team for instructions on how much water or fluid your child should drink each day. • Stay active and exercise, if possible. • Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if your child has not had a bowel movement in 3 or more days. Your care provider may recommend over the counter medications to help with their constipation. A daily stool softener such as docusate (Colace®) and/or laxative such as senna (Senokot®) may be helpful. If these do not help within 48 hours, tell your provider. Decreased white blood cells (WBCs) and increased risk for infection Your child’s WBCs should be monitored by a simple blood test. When your child’s WBCs are low, they are at a greater risk of having an infection. Take the following precautions to protect them from infection. • Have them wash their hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if they experience any signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before they take any medicine for a fever or chills. Continued on the next page SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Serious side effects Selumetinib can make your child’s heart work harder to pump blood to the rest of their body. Notify your child’s care team if your child is having shortness of breath or chest pain. Selumetinib may be harmful to your child’s eyes. Call your child’s care team if your child is having any issue with vision or if your child has pain in their eyes. If your child experiences ANY uncontrolled side effect, call your child’s physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since selumetinib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once your child has started to take selumetinib, it is important to adhere to the following instructions every day for as long as their treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • Your child may use the same toilet, septic tank, and/or sewer that they usually use. If your child uses a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Have your child wash their hands with soap and water after using the toilet. If your child needs a bedpan, be sure the caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If your child does not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or selumetinib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Possible Side Effect Management Hair changes Your child may experience hair loss. Your child’s hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Changes to your child’s hair color may occur during treatment. The hair usually returns to normal after treatment, but for some, the change is permanent. SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 8 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking selumetinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 7 days after the last dose of selumetinib. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking selumetinib and for 7 days after the last dose of selumetinib. Please inform your care provider if they become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your selumetinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.koselugo.com Product prescribing information: https://www.azpicentral.com/koselugo/koselugo.pdf Product resources: https://www.myaccess360.com/patient/koselugo selumetinib.html Updated – April 2020 Additional instructions SELUMETINIB ORAL CHEMOTHERAPY EDUCATION Page 9 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Soltamox®

(SOL-ta-mox)

Soltamox® (Tamoxifen Citrate) is used to treat certain types of hormone-dependent breast cancer and to prevent breast cancer in some high-risk individuals.

Soltamox® (Tamoxifen Citrate) is used to treat certain types of hormone-dependent breast cancer and to prevent breast cancer in some high-risk individuals.

Page 1 TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — tamoxifen citrate tuh MOK sih FEN SIH trayt Brand name — Soltamox® SOL ta mox Approved uses Tamoxifen is used to treat certain types of hormone dependent breast cancer and to prevent breast cancer in some high risk individuals Dose and schedule Taking tamoxifen as instructed is important to allow your treatment to be as effective as possible so here are some key points to remember o Your dose may vary but the usual dose of tamoxifen is 20 milligrams 20 mg to be taken by mouth at a scheduled time once a day o Tamoxifen can be taken with or without food but at the same time each day o Tamoxifen should be taken whole and not crushed cut or dissolved If you are unable to swallow tamoxifen talk to your care provider or pharmacist for possible options o If you miss a dose of tamoxifen do not take an extra dose or two doses at one time Simply take your next dose at the regularly scheduled time Be sure to write down if you miss a dose and let your care provider know about any missed doses Storage and handling Handle tamoxifen with care Just like when chemotherapy is given into the vein this drug can be toxic and exposure of the drug to others should be limited o Store tamoxifen at room temperature 68°F–77°F in a dry location away from light o Keep tamoxifen out of reach of children and pets o Leave tamoxifen in the provided packaging until it is ready to be taken o Whenever possible give tamoxifen to yourself and follow the steps below If a family member friend or caregiver needs to give tamoxifen to you they also need to follow these steps 1 Wash hands with soap and water 2 Put on gloves to avoid touching the medication Gloves are not necessary if you give the drug to yourself 3 Gently transfer the tamoxifen from its package to a small medicine or other disposable cup 4 Administer the medicine immediately by mouth with water 5 Remove gloves and do not use them for anything else 6 Throw gloves and medicine cup in household trash 7 Wash hands with soap and water TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for tamoxifen Do not mix other medications into the box with tamoxifen The person filling the box or reminder should wear gloves gloves are not necessary if you are filling the box or reminder When empty the box or reminder should be washed with soap and water before refilling Be sure to wash hands with soap and water after the task is complete whether or not gloves are worn o If you have any unused tamoxifen do not throw it in the trash and do not flush it down the sink or toilet Talk to your care provider or pharmacist about proper disposal of tamoxifen o If you are traveling put your tamoxifen in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Because tamoxifen remains in your body for several days after it is taken some of the drug may be present in urine stool sweat or vomit Once you have started to take tamoxifen it is important to follow the instructions below every day for as long as your treatment lasts This is to keep yourself loved ones and the environment as safe as possible o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient o Toilet and septic systems You may use the same toilet septic tank and/or sewer that you usually use If you have a low flow toilet close the lid and flush twice to ensure all waste has been discarded If the toilet or toilet seat becomes soiled with urine stool or vomit clean the surfaces before other people use the toilet Wash hands with soap and water after using the toilet o If you need a bedpan be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day o If you do not have good control of bladder or bowels use a disposable pad with a plastic back a diaper or a sheet to absorb body waste o Wash any skin that has been exposed to body waste or tamoxifen with soap and water o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing If you do not have a washer place the soiled linens in a plastic bag until they can be washed o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids Drug and food interactions o Tamoxifen has many drug interactions Inform your care providers of all prescription medications over the counter medications vitamins and herbal products o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines Serious side effects of tamoxifen o Tamoxifen can increase your risk of having a blood clot including stroke o Tamoxifen can increase your risk of endometrial cancer TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Tamoxifen The common side effects that have been known to happen in more than 30% of patients taking tamoxifen are listed in the left side of this table You MAY NOT experience these side effects Options to help manage any side effects that do occur are included on the right side of this table These should be discussed with your care provider If you experience any side effect you cannot manage or that is not listed here contact your care provider Possible Side Effect Management Hot flashes sudden sweating and feelings of warmth If hot flashes are bothersome Mild regular exercise program may help Consult first with your care provider Try staying in a cool environment Wear layers so that you can remove outer layers when experiencing a hot flash Avoid or limit caffeine spicy food alcohol and stress which may worsen hot flashes Inform your care provider if your hot flashes are bothersome as there may be medications that can help Increased vaginal discharge If vaginal discharge is bothersome wear a mini pad throughout the day Notify your care provider if the discharge becomes bloody or has an unusual smell Fluid retention or swelling Do not stand for long periods of time Keep your legs elevated when sitting or lying down Avoid eating salty foods which can increase swelling Avoid wearing tight fitting clothing and shoes Weigh yourself daily Contact your care provider if you notice any of the following Swelling in the hands feet or legs Shortness of breath Weight gain of five pounds or more in a week If you experience ANY uncontrolled side effect call your physician or healthcare center immediately INSTITUTIONAL CONTACT INFO TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 4 Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking tamoxifen Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two months after the last dose of tamoxifen o Do not breastfeed while taking tamoxifen and for two months after the last dose of tamoxifen o Inform your care provider if you become pregnant o It is safe to hug and kiss Special precautions may be needed for sexual activity while on oral chemotherapy and you are encouraged to ask your care provider Obtaining medication o Talk with your care provider about the process for obtaining your tamoxifen PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website http //soltamox com Product prescribing information http //soltamox com/wp content/uploads/2016/07/Soltamox FDA Approved Package Insert pdf www accessdata fda gov/drugsatfda docs/label/2005/17970s053lbl pdf Product resources http //soltamox com/resources network Updated – August 30 2017 TAMOXIFEN ORAL CHEMOTHERAPY EDUCATION Page 5 Additional instructions Important notice The Association of Community Cancer Centers ACCC Hematology/Oncology Pharmacy Association HOPA National Community Oncology Dispensing Association Inc NCODA and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources This guide does not cover all existing information related to the possible uses directions doses precautions warnings interactions adverse effects or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional Provision of this guide is for informational purposes only and does not constitute or imply endorsement recommendation or favoring of this medication by ACCC HOPA NCODA or ONS who assume no liability for and cannot ensure the accuracy of the information presented The collaborators are not making any representations with respect to the medications whatsoever and any and all decisions with respect to such medications are at the sole risk of the individual consuming the medication All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional Permission Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise easy to understand information about oral cancer drugs Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information However commercial reproduction or reuse as well as rebranding or reposting of any type are strictly prohibited without permission of the copyright holder Please email permission requests and licensing inquiries to Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved

Sonidegib

(soh-NIH-deh-gib)

Sonidegib (Odomzo®) is used to treat patients with basal cell carcinoma.

Sonidegib (Odomzo®) is used to treat patients with basal cell carcinoma.

Page 1 SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sonidegib (soh NIH deh gib) Brand name — Odomzo® (oh DOM zoh) Approved uses Sonidegib is used to treat patients with basal cell carcinoma. Dose and schedule Taking sonidegib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sonidegib is 200 milligrams (200 mg) to be taken by mouth at a scheduled time once a day. Sonidegib should be taken on an empty stomach (1 hour before or 2 hours after a meal or snack) and at the same time each day. Sonidegib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sonidegib, talk to your care provider or pharmacist for possible options. If you miss a dose of sonidegib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Sonidegib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with sonidegib; avoid eating or drinking these during treatment with sonidegib. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle sonidegib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sonidegib at room temperature (68°F–77°F) in a dry location away from light. Keep sonidegib out of reach of children and pets. Leave sonidegib in the provided packaging until it is ready to be taken. Whenever possible, give sonidegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sonidegib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the sonidegib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder will be used, contact your care team before using: • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn If you have any unused sonidegib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sonidegib. If you are traveling, put sonidegib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sonidegib Below are common side effects that have been known to happen in about one third or more of patients taking sonidegib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney (renal) function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Decreased amount of urination • Swelling in your legs and feet Changes in electrolytes and other laboratory values • High creatine phosphokinase levels • High glucose levels • High lipase levels Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your healthcare provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Muscle spasms and pain, joint pain, or weakness • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed, too. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with stress of hair loss. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: • Choose and prepare foods that look and smell good to you. • Use plastic utensils if food tastes like metal. • Flavor foods with spices to change taste. • Suck on mints or chew gum to mask taste. • Brush teeth with a soft bristle toothbrush before and after eating. • Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication that can help. Diarrhea (loose and/or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Weight loss Talk to your care provider if you notice a sudden decrease in weight while taking this medication. When you do not feel like eating, try the following: • Eat small frequent meals instead of 3 large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Take liquid nutritional supplements. • Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Serious side effects of sonidegib Sonidegib can cause serious birth defects. Do not take sonidegib if you are pregnant or think you might be pregnant. Women should use effective contraception. Men should always use a condom (even if you have had a vasectomy) during sex with female partners who are pregnant or are able to become pregnant. See pregnancy, sexual activity, and contraception section for more details. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 6 Handling body fluids and waste Because sonidegib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sonidegib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sonidegib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sonidegib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 8 months for men and 20 months for women after the last dose of sonidegib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking sonidegib and for 20 months after the last dose of sonidegib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Blood product donation Do not donate blood while on sonidegib and for at least 20 months after your last dose. SONIDEGIB ORAL CHEMOTHERAPY EDUCATION Page 7 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your sonidegib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.odomzo.com Product prescribing information: www.odomzo.com/themes/custom/odomzo/global/pdfs/pi.pdf Product resources: www.odomzo.com/support you need Updated – March 8, 2020 Additional instructions

Sorafenib

(sor-A-feh-nib)

Sorafenib (Nexavar®) is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma.

Sorafenib (Nexavar®) is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma.

Page 1 SORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — sorafenib (sor A feh nib) Brand name — Nexavar® (NEK suh var) Approved uses Sorafenib is used to treat patients with unresectable hepatocellular carcinoma, advanced kidney cancer (renal cell carcinoma), or differentiated thyroid carcinoma. Dose and schedule Taking sorafenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of sorafenib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time twice daily continuously without a scheduled off treatment period. Sorafenib should be taken on an empty stomach (one hour before or two hours after a meal or snack) at the same time each day. Sorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow sorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of sorafenib: • Do not take an extra dose or two doses at one time. Simply take the next dose at the regularly scheduled time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. If you need to have surgery, tell your care provider you are taking sorafenib. Sorafenib may need to be stopped until your wound heals after some surgeries. Drug and food interactions Sorafenib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle sorafenib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store sorafenib at room temperature (68°F–77°F) in a dry location away from light. Keep sorafenib out of reach of children and pets. Leave sorafenib in the provided packaging until it is ready to be taken. Whenever possible, give sorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give sorafenib to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the sorafenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder will be used, contact your care team before using: • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn If you have any unused sorafenib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of sorafenib. If you are traveling, put your sorafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Sorafenib Below are common side effects that have been known to happen in about one third or more of patients taking sorafenib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Diarrhea (loose and/or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Pain or discomfort in hands and/or feet Hand foot skin reaction (HFSR) appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: • Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. • Exfoliate and keep hands and feet moisturized. • Avoid tight fitting shoes or socks. • Use cushioning (i.e., gloves) when performing activities that increase pressure on the palms of your hands. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Changes in electrolytes and other laboratory values • Low albumin levels • Low phosphate levels • High lipase levels • High thyroid levels • Low calcium levels • High international normalized ratio levels • High amylase levels Changes in some laboratory values may occur and should be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: • Eat small, frequent meals instead of three large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Take liquid nutritional supplements. • Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am–4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on bottle. • Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 Serious side effects of sorafenib You may be at a higher risk of bleeding while taking Sorafenib. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. Sorafenib can increase your risk of having a heart attack. Be aware of the signs of a heart attack and seek medical attention immediately at the first sign of a heart attack. Sorafenib can cause a Hand foot skin reaction that causes redness, pain, swelling, or blisters on the palms of your hands or soles of your feet. If you get this side effect, your doctor may change your dose or stop treatment for some time. Sorafenib can cause severe diarrhea or perforation (hole) of the intestine. Tell your doctor right away if you develop fever, severe abdominal pain or diarrhea that lasts longer than a day. Sorafenib can cause increases in plasma concentrations of drugs that are substrates of UGT1A1. Sorafenib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life threatening. Tell your care team right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast while taking sorafenib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because sorafenib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take sorafenib, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or sorafenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. SORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 8 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking sorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of sorafenib. Men taking sorafenib should use condoms (even after a vasectomy) during therapy and for a minimum of two weeks after the last dose. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking sorafenib and for one month after the last dose of sorafenib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your sorafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.nexavar us.com/?WHGRedir=1 Product prescribing information: http://labeling.bayerhealthcare.com/html/products/pi/Nexavar PI.pdf Product resources: www.nexavar us.com/resources/?p=liver Updated – March 8, 2020 Additional instructions

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