Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

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Decitabine and Cedazuridine

(deh-SIH-tuh-been and SEE-daz-YOOR-ih-deen)

Decitabine and Cedazuridine (Inqovi®) is a combination product used to treat myelodysplastic syndromes (MDS).

Decitabine and Cedazuridine (Inqovi®) is a combination product used to treat myelodysplastic syndromes (MDS).

Page 1 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — decitabine and cedazuridine (deh SIH tuh been and SEE daz YOOR ih deen) Brand name — Inqovi® (in KOH vee) Approved uses Decitabine and cedazuridine is a combination product used to treat myelodysplastic syndromes (MDS). Dose and schedule Taking decitabine and cedazuridine 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 decitabine and cedazuridine is 1 tablet (35 milligrams decitabine and 100 milligrams cedazuridine) to be taken by mouth at a scheduled time once daily on days 1 to 5 of each 28 day treatment cycle. Decitabine and cedazuridine should be taken on an empty stomach, at the same time each day. Do not eat food 2 hours before or 2 hours after each dose. Decitabine and cedazuridine should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow decitabine and cedazuridine, talk to your care provider or pharmacist for possible options. If you miss a dose of decitabine and cedazuridine, follow these guidelines: • Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. • Do not take 2 doses at one time. • If vomiting occurs after a dose, do not take an additional dose but continue with the next scheduled dose. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Decitabine and cedazuridine may have 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. Storage and handling Handle decitabine and cedazuridine 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 decitabine and cedazuridine at room temperature (68°F–77°F) in a dry location away from light. Keep decitabine and cedazuridine out of reach of children and pets. Leave decitabine and cedazuridine in the provided packaging until it is ready to be taken. Whenever possible, you should give decitabine and cedazuridine to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the decitabine and cedazuridine to you, they also need to follow these steps. Page 2 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION 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 decitabine and cedazuridine 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 decitabine and cedazuridine, 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 decitabine and cedazuridine. If you are traveling, put your decitabine and cedazuridine’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Decitabine and Cedazuridine Below are common side effects that have been known to happen in about one third or more of patients taking decitabine and cedazuridine; 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 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. Continued on the next page Page 3 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION 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 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 OK 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 Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is OK 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. Continued on the next page Page 4 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management 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 3 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. Muscle or 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 OK 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 how you may ease this discomfort. Take only pain medication that has been prescribed or recommended by your care provider 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 4 times a day (after eating and at bedtime). For example, you can use 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. 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. Continued on the next page Page 5 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION 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 because of some other health problem. • 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 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. 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 to 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 rash or itching continues to worsen, contact your care provider. 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 5 or more pounds in 1 week Continued on the next page Page 6 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Serious side effects Decitabine and cedazuridine can cause serious birth defects. Do not take decitabine and cedazuridine if you are pregnant or think you might be pregnant. Decitabine and cedazuridine can lower your white blood cells and your platelets, increasing your risk of infection and bleeding. Bone marrow suppression is a decrease in the number of white blood cells, red blood cells, and platelets that can be severe with decitabine and cedazuridine. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. You also 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. Possible Side Effect Management Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your 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 • Is made worse by coughing or lowering the head 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 • High or low glucose levels • Low albumin levels • Low sodium levels • Low 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 or feet • Red or brown colored urine Page 7 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since decitabine and cedazuridine 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 decitabine and cedazuridine it is important to know 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 decitabine and cedazuridine 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 decitabine and cedazuridine. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 6 months (women) and 3 months (men) after the last dose of decitabine and cedazuridine. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking decitabine and cedazuridine and for 2 weeks after the last dose of decitabine and cedazuridine. 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. Page 8 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Obtaining medication Talk with your care provider about the process for obtaining your decitabine and cedazuridine. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.inqovi.com Product prescribing information: https://www.inqovi.com Financial assistance: www.taihopatientsupport.com Updated – October 2, 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.

Droxia™

(DROK-see-uh)

Droxia™ (Hydroxyurea)

Droxia™ (Hydroxyurea)

Page 1 HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — hydroxyurea hy DROK see yoo REE uh Brand name — Hydrea® hy DREE uh , Droxia™ DROK see uh Approved uses Hydroxyurea is used to treat adult patients with chronic myeloid leukemia, sickle cell anemia, and head and neck cancer when used with radiation. Dose and schedule Taking hydroxyurea as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Hydroxyurea can be taken with or without food but at the same time each day. Hydroxyurea should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow hydroxyurea, talk to your care provider or pharmacist for possible options. If you miss a dose of hydroxyurea, 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 hydroxyurea 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 hydroxyurea at room temperature 68°F–77°F in a dry location away from light. Keep hydroxyurea out of reach of children and pets. Leave hydroxyurea in the provided packaging until it is ready to be taken. Whenever possible, give hydroxyurea to yourself and follow the steps below. If a family member, friend, or caregiver needs to give hydroxyurea 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 hydroxyurea 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. HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for hydroxyurea. Do not mix other medications into the box with hydroxyurea. 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 hydroxyurea, 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 hydroxyurea. If you are traveling, put hydroxyurea in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because hydroxyurea 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 hydroxyurea, 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 hydroxyurea 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 Hydroxyurea 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. Avoid live vaccines during treatment with hydroxyurea. Serious side effects of hydroxyurea Hydroxyurea can cause bone marrow suppression, or a decrease in the number of white blood cells, red blood cells, and platelets, which can be severe. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. Hydroxyurea may lead to a secondary malignancy, or the growth of a cancer, months or years after treatment with hydroxyurea is complete. HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Hydroxyurea The common side effects that have been known to happen in more than 30% of patients taking hydroxyurea 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 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 HYDROXYUREA ORAL CHEMOTHERAPY EDUCATION Page 4 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 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 hydroxyurea. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of 6 months after the last dose of hydroxyurea. Men of childbearing age and potential should use effective contraception during therapy and for a minimum of one year after the last dose of hydroxyurea. Do not breastfeed while taking hydroxyurea and for one month after the last dose of hydroxyurea. 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 hydroxyurea. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.bms.com Product prescribing information: http://packageinserts.bms.com/pi/pi droxia.pdf http://packageinserts.bms.com/pi/pi hydrea.pdf Product resources: www.bms.com/patient and caregivers.html Updated – September 8, 2017 HYDROXYUREA 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 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.

Duvelisib

DOO-veh-LIH-sib

Duvelisib (Copiktra™) is used to treat adults with certain types of leukemias and lymphomas, specifically chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small lymphocytic lymphoma (SLL).

Duvelisib (Copiktra™) is used to treat adults with certain types of leukemias and lymphomas, specifically chronic lymphocytic leukemia (CLL), follicular B-cell non-Hodgkin lymphoma (FL), and small lymphocytic ...

Page 1 DUVELISIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Duvelisib DOO veh LIH sib Brand name — Copiktra™ koo PIK truh Approved uses Duvelisib is used to treat adults with certain types of leukemias and lymphomas, specifically chronic lymphocytic leukemia CLL , follicular B cell non Hodgkin lymphoma FL , and small lymphocytic lymphoma SLL . Dose and schedule Taking duvelisib 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 duvelisib is 25 milligrams 25 mg to be taken by mouth at a scheduled time twice a day. Duvelisib can be taken with or without food, but at the same times each day. Duvelisib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow duvelisib, talk to your care provider or pharmacist for possible options. If you miss a dose of duvelisib: Only take the missed dose if it has been less than 6 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than 6 hours since you should have taken it. 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. Storage and handling Handle duvelisib 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 duvelisib at room temperature 68°F–77°F in a dry location away from light. Keep duvelisib out of reach of children and pets. Leave duvelisib in the provided packaging until it is ready to be taken. Whenever possible, you should give duvelisib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the duvelisib 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 duvelisib 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. DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for duvelisib. Do not mix other medications into the box with duvelisib. 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 duvelisib, 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 duvelisib. If you are traveling, put your duvelisib in a sealed plastic bag. Ask your pharmacist if additional travel precautions are needed. Handling body fluids and waste Since duvelisib 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 duvelisib, 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 duvelisib 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 Duvelisib has many drug interactions, so 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. Serious side effects Serious infections may develop, so monitor for signs and symptoms of infection. Severe diarrhea has occurred with the use of duvelisib, so monitor for development of worsening diarrhea. Serious skin reactions can develop, so report this side effect to your healthcare provider. Lung side effects have been reported with the use of duvelisib, so monitor for shortness of breath, chest pain, or worsening cough. DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Duvelisib The common side effects that have been known to happen in more than 30% of patients taking duvelisib 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 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. 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 DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management 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 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. 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 next page DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 duvelisib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of duvelisib. Do not breastfeed while taking duvelisib and for 1 month after the last dose of duvelisib. 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 duvelisib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Possible Side Effect Management Changes in electrolytes and other laboratory values High lipase levels High amylase levels High potassium levels Low phosphorus levels Low sodium 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 and feet Red or brown colored urine DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.copiktra.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2018/211155s000lbl.pdf Product resources: 1 833 570 2273 Updated – October 5, 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.

Eltrombopag

(el-TROM-boh-pag)

Eltrombopag (Promacta®) is used to treat: • Low platelets in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) • Low platelets in patients with chronic hepatitis C • Severe aplastic anemia in patients who have not responded to other therapy

Eltrombopag (Promacta®) is used to treat: • Low platelets in adult and pediatric patients one year and older with chronic immune (idiopathic) thrombocytopenia (ITP) • Low platelets in patients with chronic hep...

Page 1 ELTROMBOPAG ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — eltrombopag el TROM boh pag Brand name — Promacta® proh MAK tuh Approved uses Eltrombopag is used to treat: Low platelets in adult and pediatric patients one year and older with chronic immune idiopathic thrombocytopenia ITP Low platelets in patients with chronic hepatitis C Severe aplastic anemia in patients who have not responded to other therapy Dose and schedule Taking eltrombopag 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 eltrombopag is between 25 milligrams 25 mg and 50 milligrams 50 mg to be taken by mouth at a scheduled time once a day. Eltrombopag should be taken on an empty stomach at least 1 hour before or 2 hours after a meal or snack at the same time each day. Eltrombopag should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow eltrombopag, talk to your care provider or pharmacist for possible options. If you miss a dose of eltrombopag, 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 eltrombopag 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 eltrombopag at room temperature 68°F–77°F in a dry location away from light. Once reconstituted, the oral suspension should be administered immediately but may be kept at room temperature 68°F–77°F for a maximum of 30 minutes. Keep eltrombopag out of reach of children and pets. Leave eltrombopag in the provided packaging until it is ready to be taken. Whenever possible, give eltrombopag to yourself and follow the steps below. If a family member, friend, or caregiver needs to give eltrombopag 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 eltrombopag 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. ELTROMBOPAG ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box or pill reminder is not recommended for use with eltrombopag. If you have any unused eltrombopag, 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 eltrombopag. If you are traveling, put your eltrombopag in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because eltrombopag 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 eltrombopag, 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 eltrombopag 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 Eltrombopag has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Eltrombopag should be taken at least 2 hours before or 4 hours after eating dairy products and drinking calcium fortified juices. Eltrombopag should be taken on an empty stomach at least 1 hour before or 2 hours after a meal or snack . Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Eltrombopag can increase the risk of severe and potentially life threatening liver toxicity in patients with chronic hepatitis C. ELTROMBOPAG ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Eltrombopag The common side effects that have been known to happen in more than 30% of patients taking eltrombopag 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 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. 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 eltrombopag. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of eltrombopag. Do not breastfeed while taking eltrombopag and for a month after the last dose of eltrombopag. 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 eltrombopag, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your eltrombopag. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO ELTROMBOPAG ORAL CHEMOTHERAPY EDUCATION Page 4 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. Additional resources Product website: www.us.promacta.com Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ promacta.pdf Product resources: www.us.promacta.com Updated — May 3, 2018 Additional instructions

Emcyt®

(N/A)

Emcyt® (Estramustine) is used to treat prostate cancer.

Emcyt® (Estramustine) is used to treat prostate cancer.

Page 1 ESTRAMUSTINE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — estramustine ES truh MUS teen Brand name — Emcyt® Approved uses Estramustine is used to treat prostate cancer. Dose and schedule Taking estramustine as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Estramustine should be taken on any empty stomach at least one hour before or two hours after meals. Your doctor may want you to take this medication multiple times throughout the day. Estramustine should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow estramustine, talk to your care provider or pharmacist for possible options. If you miss a dose of estramustine, 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 estramustine 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 estramustine in the refrigerator 36°F–46°F . Do not freeze. Keep estramustine out of reach of children and pets. Leave estramustine in the provided packaging until it is ready to be taken. Whenever possible, you should give estramustine to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the estramustine 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 estramustine 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. ESTRAMUSTINE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for estramustine. Do not mix other medications into the box with estramustine. 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 estramustine, 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 estramustine. If you are traveling, put your estramustine in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since estramustine 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 estramustine, 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 estramustine 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 Estramustine has many drug interactions. Please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Estramustine should be taken without food, one hour before or two hours after meals. Do not take estramustine with calcium containing antacids, such as calcium carbonate TUMS® , or calcium supplements. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. ESTRAMUSTINE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Estramustine The common side effects that have been known to happen in more than 30% of patients taking estramustine 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 Breast swelling or pain in breast or nipple Notify your care provider if you are experiencing significant pain. Changes in electrolytes and other laboratory values Lactate dehydrogenase Changes in some lab 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 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 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Men should not get a partner pregnant while taking estramustine. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of seven days after the last dose of estramustine. 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. ESTRAMUSTINE ORAL CHEMOTHERAPY EDUCATION Page 4 Obtaining medication Talk with your care provider about the process for obtaining your estramustine. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2008/018045s023lbl.pdf Updated – October 19, 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 © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Enasidenib

(EH-nuh-SIH-deh-nib)

Enasidenib (Idhifa®) is used to treat patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH-2) mutation.

Enasidenib (Idhifa®) is used to treat patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH-2) mutation.

Page 1 ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — enasidenib EH nuh SIH deh nib Brand name — Idhifa® ide HEE fuh Approved uses Enasidenib is used to treat patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 IDH 2 mutation. Dose and schedule Taking enasidenib 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 enasidenib is 100 milligrams 100 mg to be taken by mouth once daily. The dose may be adjusted by your care provider based upon your individual needs. Enasidenib can be taken with or without food, but at the same time each day. Enasidenib should be swallowed whole with 1 cup 8 ounces of water. Do not crush, cut, or dissolve the tablet. If you are unable to swallow enasidenib, talk to your care provider or pharmacist for possible options. If you miss or vomit immediately after a dose of enasidenib, take an extra dose as soon as possible and return to your normal schedule the following day. 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. Storage and handling Handle enasidenib 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 enasidenib at room temperature 68°F–77°F in a dry location away from light in its original bottle with the desiccant canister i.e., moisture controller . Keep enasidenib out of reach of children and pets. Leave enasidenib in the provided packaging until it is ready to be taken. Whenever possible, give enasidenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give enasidenib 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 enasidenib 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. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 2 A daily pill box is not recommended to be used with enasidenib. You should keep the medication in the original bottle. If you have any unused enasidenib, 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 enasidenib. If you are traveling, put your enasidenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Enasidenib remains in your body for several days after it is taken, so some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take enasidenib, 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 enasidenib 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 Enasidenib has the potential for drug interactions. Inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products that you are taking. Enasidenib can be taken with or without food. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Differentiation syndrome is a condition that affects your blood cells and may be life threatening or lead to death if not treated. Go to the nearest hospital emergency room or call 911 if you develop any of these symptoms: fever, cough, shortness of breath, bone pain, fast weight gain 10 lbs within one week , or swelling of arms and legs, around the neck, groin, or underarm. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Enasidenib The common side effects that have been known to happen in more than 30% of patients taking enasidenib 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 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 Changes in electrolytes and other laboratory values Low calcium levels Low potassium 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 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. Continued on the next page ENASIDENIB 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 any of the following occur: 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. 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 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. 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 enasidenib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of enasidenib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of enasidenib. Do not breastfeed while taking enasidenib and for one month after the last dose of enasidenib. Inform your care provider if you become pregnant. ENASIDENIB ORAL CHEMOTHERAPY EDUCATION Page 5 It is safe to hug and kiss. Special precautions may be needed for sexual activity while on enasidenib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your enasidenib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: https://www.idhifa.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2017/209606s000lbl.pdf Product resources: https://idhifapro.com/access and support/#patientResources Updated — March 4, 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.

Encorafenib

(en-koe RAF-e-nib)

Encorafenib (Braftovi®) is used to treat patients with Metastatic colorectal cancer that has a genetic mutation called BRAF V600E mutation and is be used in combination with cetuximab.

Encorafenib (Braftovi®) is used to treat patients with Metastatic colorectal cancer that has a genetic mutation called BRAF V600E mutation and is be used in combination with cetuximab.

Page 1 ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — encorafenib (en koe RAF e nib) Brand name — Braftovi® (braf TOH vee) Approved uses Encorafenib is used to treat patients with: Metastatic colorectal cancer that has a genetic mutation called BRAF V600E mutation and is be used in combination with cetuximab. Dose and schedule Taking encorafenib 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 encorafenib is 300 milligram (300 mg) to be taken by mouth at a scheduled time once a day. Encorafenib can be taken with or without food, but at the same time each day. Encorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow encorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of encorafenib, follow these guidelines: • Only take the missed dose if it has been less than 12 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 Encorafenib has many drug interactions, please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with encorafenib; avoid eating or drinking these during treatment with encorafenib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle encorafenib 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 encorafenib at room temperature (68°F to 77°F) in a dry location away from light. Keep encorafenib out of reach of children and pets. Leave encorafenib in the provided packaging until it is ready to be taken.ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Encorafenib Below are common side effects that have been known to happen in about one third or more of patients taking encorafenib 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 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. Continued on the next page Whenever possible, you should give encorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the encorafenib 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 encorafenib 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 encorafenib. If you have any unused encorafenib, 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 encorafenib. If you are traveling, put your encorafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Serious side effects of encorafenib The development of skin and non skin cancers have been observed in patients who have taken encorafenib. It is recommended that you perform self skin exams prior to starting encorafenib and then every 2 months during treatment, and for up to 6 months following stopping encorafenib. Bleeding has been reported with encorafenib. Report any bleeding to your healthcare provider. Eye changes, which include redness, pain, and blurred vision, have been reported. Consult your doctor on how regularly you should get an eye exam. Be aware of changes in the electrical activity of your heart, called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking encorafenib with binimetinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Possible Side Effect Management 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 Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice either of the following: • Decreased amount of urination • Unusual swelling in your legs and feet 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 bruisingENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Handling body fluids and waste Since encorafenib 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 encorafenib, it is important to know 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 encorafenib 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 encorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 2 weeks after the last dose of encorafenib. Discuss with your care provider about effective contraception during treatment as encorafenib has the potential to render hormonal contraceptives ineffective. Do not breastfeed while taking encorafenib and for 2 weeks after the last dose of encorafenib. 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.ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about the process for obtaining your encorafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.braftovihcp.com Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=12990 Product resources: https://www.braftovihcp.com/access and support Updated – May 28, 2021 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved

Encorafenib and Binimetinib

((EN-kor-A-feh-nib) and (BIH-nee-MEH-tih-nib))

Encorafenib and Binimetinib (Braftovi® and Mektovi®) is used to treat patients with melanoma that have a genetic mutation called BRAF V600E or V600K.

Encorafenib and Binimetinib (Braftovi® and Mektovi®) is used to treat patients with melanoma that have a genetic mutation called BRAF V600E or V600K.

Page 1 ENCORAFENIB AND BINIMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic names — encorafenib (EN kor A feh nib) and binimetinib (BIH nee MEH tih nib) Brand names — Braftovi® (braf TOH vee) and Mektovi® (mek TOH vee) Please make sure to follow the instructions on the side of the table that your provider has checked. Approved uses The combination of encorafenib and binimetinib is used to treat patients with melanoma that have a genetic mutation called BRAF V600E or V600K. Dose and schedule Taking encorafenib and binimetinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. For both encorafenib and binimetinib, do not take two doses at one time, and be sure to write down if you miss a dose and to let your care provider know about any missed doses. Do not take an additional dose of either medication if vomiting occurs after administration. Continue with the next scheduled dose. Both encorafenib and binimetinib can be taken with or without food, but at the same time each day. Encorafenib and binimetinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow encorafenib and binimetinib, talk to your care provider or pharmacist for possible options. Drug and food interactions Encorafenib and binimetinib have many drug interactions. Inform your care providers of all prescription medications, overthe counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with encorafenib; avoid eating or drinking these during treatment with encorafenib. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle encorafenib and binimetinib with care. Just like when chemotherapy is given into the vein, these drugs can be toxic, and exposure of the drugs to others should be limited. Store encorafenib and binimetinib at room temperature (68°F–77°F) in a dry location away from light. Usual dose: 450 mg (six 75 mg capsules) by mouth once daily If you miss a dose: Only take if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Usual dose: 45 mg (three 15 mg tablets) by mouth twice daily If you miss a dose: Only take if it has been less than 6 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Encorafenib Binimetinib ENCORAFENIB AND BINIMETINIBORAL CHEMOTHERAPY EDUCATION Page 2 ENCORAFENIB AND BINIMETINIB Keep out of reach of children and pets. Leave encorafenib and binimetinib in the provided packaging until it is ready to be taken. Whenever possible, you should give these medications to yourself and follow the steps below. If a family member, friend, or caregiver needs to give them 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 medication 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 reminder may be used for binimetinib (but not for encorafenib, as it should be kept in the original packaging). Contact your care team before using a daily pill box. • The person filling the box or reminder should wear gloves (gloves are not necessary if you as the patient 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 encorafenib and binimetinib, 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 these medications. If you are traveling, put your medications in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.ORAL CHEMOTHERAPY EDUCATION Page 3 ENCORAFENIB AND BINIMETINIB Side Effects of Encorafenib and Binimetinib The common side effects that have been known to happen in more than 30% of patients taking encorafenib and binimetinib 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 will be checked periodically by a simple blood test. Contact your care provider if you notice either of the following: • Decreased amount of urination • Unusual swelling in your legs and feet Changes in electrolytes and other laboratory values • High creatine phosphokinase • High gamma glutamyl transferase Changes in some lab 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 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. Continued on the next pageORAL CHEMOTHERAPY EDUCATION Page 4 ENCORAFENIB AND BINIMETINIB 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. 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 because of some other health problem. • 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 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. 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 OK 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 • PalpitationsORAL CHEMOTHERAPY EDUCATION Page 5 ENCORAFENIB AND BINIMETINIB Serious side effects You may be at a higher risk of bleeding while taking these medications. 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. These medications may be harmful to your eyes. Be sure to inform your care provider of any issues you have with your vision or pain in your eyes. Your provider may stop treatment with either of these medications if your eyes are affected. The development of skin and non skin cancers have been observed in patients who have taken encorafenib. It is recommended that you perform a skin self examination prior to starting encorafenib and then every 2 months during treatment, and for up to 6 months following stopping encorafenib. Encorafenib 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 encorafenib. Binimetinib can increase your risk of a blood clot. Notify your healthcare provider right away if you notice any swelling or pain (especially with movement) in your arms or legs, as well as shortness of breath or chest pain. Binimetinib can make your heart work harder to pump blood to the rest of your body. Notify your healthcare provider if you experience shortness of breath or chest pain. Binimetinib may be harmful to your lungs. Inform your care provider of any new difficulty breathing, cough, or fever. Your provider may stop treatment with binimetinib if your lungs are affected. Binimetinib 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. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since encorafenib and binimetinib remain in your body for several days after they are taken, some of these drugs may be present in urine, stool, sweat, or vomit. Once you have started to take these medications, it is important to follow these 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 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.ORAL CHEMOTHERAPY EDUCATION Page 6 ENCORAFENIB AND BINIMETINIB 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 these medications 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 encorafenib and binimetinib. 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 these medications. o Discuss with your care provider about effective contraception during treatment as encorafenib has the potential to render hormonal contraceptives ineffective. These medications can interfere with hormonal contraception. Talk to your care team for more information. o Do not breastfeed while taking these medications and for 30 days after the last dose. 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 encorafenib and binimetinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.braftovimektovi.com/hcp Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=12990 (encorafenib), http://labeling.pfizer.com/ShowLabeling.aspx?id=12988 (binimetinib) Product resources: https://www.braftovimektovi.com/patient support Updated – May 28, 2021 Additional instructions ORAL CHEMOTHERAPY EDUCATION Page 7 ENCORAFENIB AND BINIMETINIB 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

Entrectinib

(en-TREK-tih-nib)

Entrectinib (Rozlytrek®) 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.

Entrectinib (Rozlytrek®) 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.

Enzalutamide

(EN-zuh-LOO-tuh-mide)

Enzalutamide (Xtandi®) is used to treat men with prostate cancer.

Enzalutamide (Xtandi®) is used to treat men with prostate cancer.

ShowAll Page 1 ENZALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — enzalutamide (EN-zuh-LOO-tuh-mide) Brand name — Xtandi® (ek-STAN-dee) Approved uses Enzalutamide is used to treat men with prostate cancer Dose and schedule Taking enzalutamide 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 enzalutamide is 160 milligrams (160 mg) to be taken by mouth at a scheduled time once a day o Enzalutamide can be taken with or without food but at the same time each day o Enzalutamide should be taken whole and not crushed cut or dissolved If you are unable to swallow enzalutamide talk to your care provider or pharmacist for possible options o If you miss a dose of enzalutamide 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 enzalutamide 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 enzalutamide at room temperature (68°F–77°F) in a dry location away from light o Keep enzalutamide out of reach of children and pets o Leave enzalutamide in the provided packaging until it is ready to be taken o Whenever possible give enzalutamide to yourself and follow the steps below If a family member friend or caregiver needs to give enzalutamide 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 enzalutamide 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 ENZALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 o A daily pill box or pill reminder is not recommended for use with enzalutamide o If you have any unused enzalutamide 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 enzalutamide o If you are traveling put your enzalutamide in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Enzalutamide remains in your body for several days after it is taken so some of the drug may be present in urine stool sweat or vomit Once you have started to take enzalutamide 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 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 enzalutamide 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 Enzalutamide has many drug interactions Inform your care providers of all prescription medications over-the-counter medications vitamins and herbal products that you are taking o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines ENZALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Enzalutamide The common side effects that have been known to happen in more than 30% of patients taking enzalutamide 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 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 If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: _ (INSTITUTIONAL CONTACT INFO) Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking enzalutamide Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of three months after the last dose of enzalutamide 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 enzalutamide and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your enzalutamide (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www xtandi com Product prescribing information: www astellas us/docs/us/12A005-ENZ-WPI pdf?v=1 Product resources: www xtandi com/patient-videos Updated – August 20 2017 ENZALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 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

Erdafitinib

(ER-duh-FIH-tih-nib)

Erdafitinib (Balversa®) is used to treat bladder cancer that has a genetic mutation called fibroblast growth factor receptor (FGFR).

Erdafitinib (Balversa®) is used to treat bladder cancer that has a genetic mutation called fibroblast growth factor receptor (FGFR).

Page 1 ERDAFITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — erdafitinib (ER duh FIH tih nib) Brand name — Balversa® (bal VER sah) Approved uses Erdafitinib is used to treat bladder cancer that has a genetic mutation called fibroblast growth factor receptor (FGFR). Dose and schedule Taking erdafitinib 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 erdafitinib is 8 milligrams (8 mg) to be taken by mouth at a scheduled time once a day. Your doctor may increase your dose to 9 milligrams (9 mg) daily after the first few weeks of treatment. Erdafitinib can be taken with or without food, but at the same time each day. Erdafitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow erdafitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of erdafitinib, follow these guidelines: • Take the missed dose as soon as possible on the same day. • 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 Erdafitinib 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 erdafitinib; avoid eating or drinking this during treatment with erdafitinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. For the first three weeks while taking erdafitinib, limit phosphate intake to 600 to 800 mg per day and avoid medications that can raise phosphate levels. Examples include potassium phosphate supplements, vitamin D supplements, antacids, and phosphate containing enemas or laxatives. Talk to your healthcare provider about other medications that may also contain phosphate. ERDAFITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle erdafitinib 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 erdafitinib at room temperature (68°F–77°F) in a dry location away from light. Keep erdafitinib out of reach of children and pets. Leave erdafitinib in the provided packaging until it is ready to be taken. Whenever possible, you should give erdafitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the erdafitinib 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 erdafitinib 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 erdafitinib. If you have any unused erdafitinib, 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 erdafitinib. If you are traveling, put your erdafitinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. ERDAFITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Erdafitinib Below are common side effects that have been known to happen in about one third or more of patients taking erdafitinib 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 Mouth irritation, mouth 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 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. Changes in electrolytes and other laboratory values • High phosphate levels • Low sodium levels • Low magnesium levels Changes in some lab 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 Continued on the next page ERDAFITINIB 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 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. 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. 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 Nail changes Usually this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, and picking at your nails can increase the risk of getting an infection. • Talk to your care provider if you notice any changes in your nails. 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 ERDAFITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management 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. – Use 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. 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 health care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Rash or dry 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 because 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 rash or itching continues to worsen, contact your care provider. ERDAFITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Serious side effects of erdafitinib Erdafitinib can cause serious birth defects. Do not take erdafitinib if you are pregnant or think you might be pregnant. Erdafitinib may cause eye problems. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), and problems of the retina (an internal part of the eye). Tell your care team right away if you develop blurred vision, loss of vision, or visual changes. You should use artificial tears (hydrating or lubricating eye gels or ointments) at least every two hours during waking hours to help prevent dry eyes. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since erdafitinib 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 erdafitinib, it is important to know 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 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 erdafitinib 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 erdafitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of erdafitinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking erdafitinib and for one month after the last dose of erdafitinib. 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. ERDAFITINIB 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your erdafitinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.balversa.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212018s000lbl.pdf Updated – July 15, 2021 Additional instructions

Erivedge®

(AYR-ih-vej)

Erivedge® (Vismodegib) is used to treat advanced or metastatic basal cell carcinoma.

Erivedge® (Vismodegib) is used to treat advanced or metastatic basal cell carcinoma.

Page 1 VISMODEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — vismodegib (VIS moh DEH gib) Brand name — Erivedge® (AYR ih vej) Approved uses Vismodegib is used to treat advanced or metastatic basal cell carcinoma. Dose and schedule Taking vismodegib 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 vismodegib is 150 milligrams (150 mg) to be taken by mouth daily. Vismodegib can be taken with or without food, but at the same time each day. Vismodegib capsules should be taken whole and not crushed, opened, or dissolved. If you are unable to swallow vismodegib, talk to your care provider or pharmacist for possible options. If you miss a dose of vismodegib, 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 Vismodegib 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. Storage and handling Handle vismodegib 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 vismodegib at room temperature (68°F–77°F) in a dry location away from light. Keep vismodegib out of reach of children and pets. Leave vismodegib in the provided packaging until it is ready to be taken. Whenever possible, you should give vismodegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the vismodegib 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 vismodegib 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. VISMODEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Vismodegib Below are common side effects that have been known to happen in about one third or more of patients taking vismodegib 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 Muscle spasms • Keep a diary of your spasms, 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 spasms interfere with your activity. If the pain or spasms bother you, ask your provider what you may use to help with this discomfort. Take only medication that has been prescribed or recommended by your care provider. Hair loss (alopecia) Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short hair cut prior to treatment may help with the stress of hair loss. 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 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 vismodegib, 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 vismodegib. If you are traveling, put your vismodegib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. VISMODEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management 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. • 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. 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. 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 because of some other health problem. • 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 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. VISMODEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 Serious side effects of vismodegib Vismodegib can cause serious birth defects. Do not take vismodegib if you are pregnant or think you might be pregnant. Both men and women should use effective contraception during and after vismodegib therapy. (See “Pregnancy, Sexual Activity, and Contraception” section for more detailed information.) If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since vismodegib 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 vismodegib, it is important to know 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 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 vismodegib 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 vismodegib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of 24 months after the last dose of vismodegib. Males should wear condoms during therapy and for a minimum of three months after the last dose of vismodegib to avoid drug exposure to pregnant partners and female partners of reproductive potential because the drug can be found in sperm. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking vismodegib and for 24 months after the last dose of vismodegib. Men should not donate semen while taking vismodegib and for up to three months after the final dose. VISMODEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 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. Please inform your care provider if you become pregnant. It is safe to hug and kiss, but the special precautions described above are required before sexual activity. Blood product donation It is recommended that you do not donate blood or blood products (such as platelets) while receiving vismodegib and for at least 24 months after the last dose of vismodegib. Obtaining medication Talk with your care provider about the process for obtaining your vismodegib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.erivedge.com Product prescribing information: www.gene.com/download/pdf/erivedge prescribing.pdf Product resources: www.gene.com/patients/medicines/erivedge Updated – September 11, 2020 Additional instructions

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