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Iclusig®

(i-KLOO-sig)

Iclusig® (Ponatinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+) and acute lymphoblastic leukemia (ALL) that is Ph+.

Iclusig® (Ponatinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+) and acute lymphoblastic leukemia (ALL) that is Ph+.

Page 1 PONATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Ponatinib poh NA tih nib Brand name — Iclusig® i KLOO sig Approved uses Ponatinib is used to treat adults with chronic myeloid leukemia CML that is Philadelphia chromosome–positive Ph+ and acute lymphoblastic leukemia ALL that is Ph+. Dose and schedule Taking ponatinib 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 ponatinib is 45 milligrams 45 mg to be taken by mouth at a scheduled time once a day. Ponatinib can be taken with or without food, but at the same time each day. Ponatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ponatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ponatinib, 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 ponatinib 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 ponatinib at room temperature 68°F–77°F in a dry location away from light. Keep ponatinib out of reach of children and pets. Leave ponatinib in the provided packaging until it is ready to be taken. Whenever possible, give ponatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give ponatinib to you, they may also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the ponatinib 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 is used, a separate one should be used for ponatinib. Do not mix other medications into the box with ponatinib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 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 ponatinib, 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 ponatinib. If you are traveling, put your ponatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ponatinib 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 ponatinib, 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 ponatinib 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 Ponatinib has many drug interactions, please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with ponatinib; avoid eating or drinking these during your treatment with ponatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Ponatinib can cause serious cardiovascular events, including heart failure, fatal myocardial infarction heart attack , stroke, and venous thromboembolism blood clot . Notify your care provider immediately if you experience any of the following PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ponatinib The common side effects that have been known to happen in more than 30% of patients taking ponatinib 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 Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal or diary and report this information to your physician. Contact your healthcare provider for high blood pressure or if symptoms such as the following occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling 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 UV ultraviolet radiation occurs between 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed on the bottle. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Continued on the next page symptoms: shortness of breath; significant weight gain; swelling in the arms or legs; numbness or weakness on one side of your body; trouble speaking or thinking; change in balance; change in eye sight; chest, arm, leg, back, neck, or jaw pain or pressure. Ponatinib can cause liver failure. Notify your care provider immediately if you have signs of liver problems like dark urine, feeling tired or not hungry, have an upset stomach or stomach pain, have light colored stools, are throwing up, or have yellow skin or eyes. PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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 such as: 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. Changes in electrolytes and other laboratory values High glucose levels High lipase levels Low phosphorous levels Low calcium 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 PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of your pancreas pancreatitis . Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache: Follows a head injury Is severe or starts suddenly Does not go away after 3 days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, made worse by coughing or lowering the head, rash, weakness in an arm or leg, or numbness Continued on the next page PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 laxative such as senna Senokot® may be helpful. If these do not help within 48 hours, tell your provider. 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 Unusual bleeding or bruising 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: Shortness of breath Dizziness Palpitations 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 PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Possible Side Effect Management Joint pain Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know that it is okay to rest as needed. 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. 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 ponatinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of three weeks after the last dose of ponatinib. Do not breastfeed while taking ponatinib and for six days after the last dose of ponatinib. 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 ponatinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ponatinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO PONATINIB ORAL CHEMOTHERAPY EDUCATION Page 8 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional resources Product website: http://www.iclusig.com Product prescribing information: http://www.iclusig.com/pi Product resources: http://www.iclusig.com/support and resources Updated — March 6, 2018 Additional instructions

Idelalisib

(i-deh-luh-LIH-sib)

Idelalisib (Zydelig®) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:
• Chronic lymphocytic leukemia (CLL)
• Follicular B-cell non-Hodgkin lymphoma (FL)
• Small lymphocytic lymphoma (SLL)

Idelalisib (Zydelig®) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:
• Chronic lymphocytic leukemia (CLL)
• Follicular B-cell n...

Page 1 IDELALISIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — idelalisib i deh luh LIH sib Brand name — Zydelig® zy DEH lig Approved uses Idelalisib is used to treat adults with certain types of leukemias and lymphomas, specifically the following: Chronic lymphocytic leukemia CLL Follicular B cell non Hodgkin lymphoma FL Small lymphocytic lymphoma SLL Dose and schedule Taking idelalisib 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 idelalisib is 150 milligrams 150 mg to be taken by mouth at a scheduled time twice a day. Idelalisib can be taken with or without food, but at the same time each day. Idelalisib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow idelalisib, talk to your care provider or pharmacist for possible options. If you miss a dose of idelalisib, follow these guidelines: Only take the missed dose if it has been less than six 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 six 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 idelalisib 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 idelalisib at room temperature 68°F–77°F in a dry location away from light. Keep idelalisib out of reach of children and pets. Leave idelalisib in the provided packaging until it is ready to be taken. Whenever possible, you should give idelalisib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the idelalisib 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. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the idelalisib 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 is used, a separate one should be used for idelalisib. Do not mix other medications into the box with idelalisib. 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 idelalisib, 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 idelalisib. If you are traveling, put your idelalisib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since idelalisib 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 idelalisib, 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 idelalisib 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 Idelalisib 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 idelalisib. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 3 Serious side effects Idelalisib can cause serious liver damage. Idelalisib can cause severe diarrhea, inflammation of the colon commonly called colitis , or perforation hole of the intestine. Idelalisib can cause inflammation of the lungs commonly called pneumonitis . Idelalisib can increase your risk for infections that are very serious and may lead to death. Side Effects of Idelalisib The common side effects that have been known to happen in more than 30% of patients taking idelalisib 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. 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 Abdominal pain Continued on the next page IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Problems with your lungs Contact your provider if you have any new or worsening lung problems, including cough, shortness of breath, wheezing, or difficult breathing. This may be a sign of pneumonia an infection in the lungs or pneumonitis inflammation of the lungs . 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 four or more. You feel dizzy or lightheaded. You have diarrhea along with severe abdominal pain, nausea or vomiting, chills, or fever. 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. 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 idelalisib. 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 idelalisib. Do not breastfeed while taking idelalisib and for one month after the last dose of idelalisib. 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. IDELALISIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about the process for obtaining your idelalisib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.zydelig.com Product prescribing information: www.gilead.com/~/media/Files/pdfs/medicines/oncology/zydelig/zydelig pi.pdf Product resources: www.zydeligaccessconnect.com/hcp Updated – January 15, 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.

Idhifa®

(ide-HEE-fuh)

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

Idhifa® (Enasidenib) 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.

Imatinib

(ih-MA-tih-nib)

Imatinib (Gleevec®) is used to treat adult and pediatric patients with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+) and acute lymphoblastic leukemia (ALL) that is Ph+. Other approved uses in adults include the following:

  • Gastrointestinal stromal tumors ...

Imatinib (Gleevec®) is used to treat adult and pediatric patients with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+) and acute lymphoblastic leukemia (ALL) that is Ph+. Other ...

Page 1 IMATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — imatinib ih MA tih nib Brand name — Gleevec® GLEE vek Approved uses Imatinib is used to treat adult and pediatric patients with chronic myeloid leukemia CML that is Philadelphia chromosome–positive Ph+ and acute lymphoblastic leukemia ALL that is Ph+. Other approved uses in adults include the following: Gastrointestinal stromal tumors GISTs that are Kit CD117 positive Myelodysplastic/myeloproliferative diseases MDS/MPD with platelet derived growth factor receptor PDGFR gene rearrangements Aggressive systemic mastocytosis ASM without the D816V c Kit mutation Hypereosinophilic syndrome and/or chronic eosinophilic leukemia CEL Dermatofibrosarcoma protuberans DFSP Dose and schedule Taking imatinib 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 imatinib is 100 milligrams 100 mg to 600 milligrams 600 mg to be taken by mouth at a scheduled time once a day. Imatinib should be taken with food at the same time each day. Imatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow imatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of imatinib, 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 imatinib 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 imatinib at room temperature 68°F–77°F in a dry location away from light. Keep imatinib out of reach of children and pets. Leave imatinib in the provided packaging until it is ready to be taken. Whenever possible, give imatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give imatinib to you, they may also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the imatinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. IMATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 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 for use with imatinib. If you have any unused imatinib, 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 imatinib. If you are traveling, put your imatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since imatinib 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 imatinib, 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 imatinib 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 Imatinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Imatinib should be taken with food. Grapefruit or grapefruit juice may interact with imatinib; avoid eating or drinking these during your treatment with imatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. IMATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Imatinib The common side effects that have been known to happen in more than 30% of patients taking imatinib 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 such as: 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: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page IMATINIB 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 Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice: Swelling in the hands, feet, or legs Shortness of breath Weight gain of 5 pounds or more in a week 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. 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 okay to rest as needed. Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Continued on the next page IMATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with diarrhea, but talk to your care provider before starting this medication. 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 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. 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 UV ultraviolet radiation occurs from 10 am–4 pm. Wear long sleeved clothing, with UV protection if possible. Wear broad brimmed hats. Apply broad spectrum sunscreen UVA/UVB with at least SPF 30 as often as directed. Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Continued on the next page IMATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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: Follows a head injury Is severe or starts suddenly Does not go away after 3 days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, rash, weakness in an arm or leg, or numbness; or is made worse by coughing or lowering the head. Abdominal pain Abdominal pain or discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of the pancreas pancreatitis . Changes in electrolytes and other laboratory values Low potassium 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 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 imatinib. Men and women of childbearing potential should use effective contraception during therapy and for a minimum of 14 days after the last dose of imatinib. Do not breastfeed while taking imatinib and for one month after the last dose of imatinib. 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 imatinib, and you are encouraged to ask your care provider. IMATINIB 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 © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your imatinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.gleevec.com/index.jsp Product prescribing information: www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/ gleevec tabs.pdf Product resources: www.gleevec.com/patient/patient resource support.jsp Updated — March 6, 2018 Additional instructions

Imbruvica®

(im-BROO-vih-kuh)

Imbruvica® (Ibrutinib) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:

  • Chronic lymphocytic leukemia (CLL)
  • Small lymphocytic lymphoma (SLL)
  • Wal...

Imbruvica® (Ibrutinib) is used to treat adults with certain types of leukemias and lymphomas, specifically the following:

  • Chronic lymphocytic leukemia...

Page 1 IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ibrutinib i BROO tih nib Brand name — Imbruvica® im BROO vih kuh Approved uses Ibrutinib is used to treat adults with certain types of leukemias and lymphomas, specifically the following: Chronic lymphocytic leukemia CLL Mantle cell lymphoma MCL Marginal zone lymphoma MZL Small lymphocytic lymphoma SLL Waldenstrom macroglobulinemia WM Ibrutinib can also be used to treat adults who have received a bone marrow transplant and now have chronic graft versus host disease cGVHD . Dose and schedule Taking ibrutinib 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 ibrutinib is 420 milligrams 420 mg or 560 milligrams 560 mg to be taken by mouth at a scheduled time once a day. Ibrutinib can be taken with or without food, but at the same time each day. Ibrutinib should be taken whole and not opened, crushed, cut, or dissolved. If you are unable to swallow ibrutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of ibrutinib, take your missed dose as soon as possible on the same day and then return to your normal schedule the next day. Do not take an extra dose or two doses at one time to make up for the missed dose. 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 ibrutinib 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 ibrutinib at room temperature 68°F–77°F in a dry location away from light. Keep ibrutinib out of reach of children and pets. Leave ibrutinib in the provided packaging until it is ready to be taken. Whenever possible, you should give ibrutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ibrutinib 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 ibrutinib from its package to a small medicine or other disposable cup. IBRUTINIB 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, a separate one should be used for ibrutinib. Do not mix other medications into the box with ibrutinib. 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 ibrutinib, 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 ibrutinib. If you are traveling, put your ibrutinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since ibrutinib 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 ibrutinib, 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 ibrutinib 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 Ibrutinib has many drug interactions. Inform your care provider of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice and Seville oranges often found in marmalades may interact with ibrutinib; avoid eating or drinking these during treatment with ibrutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ibrutinib The common side effects that have been known to happen in more than 30% of patients taking ibrutinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include 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 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 IBRUTINIB 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 due to some other health problem. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. 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. Respiratory tract infection Wash your hands often, especially before eating and after using the bathroom. Avoid people with fevers, flu, or other infections. Maintain good personal hygiene. Report symptoms of a respiratory infection, like cough, sneezing, runny nose, fever, and scratchy or sore throat, to your provider. 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 IBRUTINIB 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 ibrutinib. 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 ibrutinib. Do not breastfeed while taking ibrutinib and for one month after the last dose of ibrutinib. Possible Side Effect Management 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 okay to rest as needed. Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week 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. IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ibrutinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.imbruvica.com Product prescribing information: www.imbruvica.com/docs/librariesprovider7/default document library/prescribing information.pdf Product resources: www.imbruvica.com/you i support Updated – January 16, 2018 Additional instructions

Inlyta®

(in-LY-tuh)

Inlyta® (Axitinib) is used to treat patients with advanced kidney cancer (renal cell carcinoma).

Inlyta® (Axitinib) is used to treat patients with advanced kidney cancer (renal cell carcinoma).

Page 1 AXITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — axitinib (AK sih TIH nib) Brand name — Inlyta® (in LY tuh) Approved uses Axitinib is used to treat patients with advanced kidney cancer (renal cell carcinoma). Dose and schedule Taking axitinib 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 axitinib is 5 milligrams (5 mg) to be taken by mouth at a scheduled time twice daily (about 12 hours apart). Axitinib can be taken with or without food with a full glass of water, but at the same time each day. Axitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow axitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of axitinib, 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. If you need to have surgery, tell your care provider you are taking axitinib. Axitinib may need to be stopped until your wound heals after some surgeries. Drug and food interactions Axitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with axitinib. Avoid eating or drinking these during treatment with axitinib. Talk with your care team or pharmacist before taking new medications or supplements or receiving any vaccines. Storage and handling Handle axitinib 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 axitinib at room temperature (68°F–77°F) in a dry location away from light. Keep axitinib out of reach of children and pets. Leave axitinib in the provided packaging until it is ready to be taken. Whenever possible, give axitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give axitinib 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.)AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the axitinib 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 axitinib, 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 axitinib. If you are traveling, put your axitinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Axitinib Below are common side effects that have been known to happen in about one third or more of patients taking axitinib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next pageAXITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 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 Changes in electrolytes and other laboratory values • Low bicarbonate levels • Low calcium levels • High blood glucose • Low alkaline phosphatase 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 Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your care provider for high blood pressure or if the following symptoms occur: • Headache • Dizziness • Chest pain • Shortness of breath • Fluid retention, weight gain, or swelling Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed, 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 pageAXITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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. • 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. 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 care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations 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 pageAXITINIB 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. Voice changes or hoarseness These changes are not permanent and should go away during the time you are not taking the medication. 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 Serious side effects of axitinib Axitinib can increase your risk of having a stroke. Be aware of the signs of a stroke and seek medical attention immediately at the first sign of a stroke. Axitinib can increase your risk of having a heart attack. Be aware of the signs of a heart attack and seek medical attention immediately at the first sign of a heart attack. If you need to have a surgical or dental procedure, tell your doctor that you are taking axitinib. You may need to stop axitinib until your wound heals after some types of surgery. Axitinib may be harmful to your thyroid. Speak to your care provider to know when you need to have laboratory tests done to monitor your thyroid function. Your doctor may prescribe medication to keep your thyroid functioning properly. Axitinib can cause severe diarrhea or perforation (hole) of the intestine. Tell your doctor right away if you develop fever, severe abdominal pain or diarrhea that lasts longer than a day. A condition called reversible posterior leukoencephalopathy syndrome can occur while taking axitinib. Call your healthcare provider immediately if you have headaches, seizures, confusion or changes in vision. You may be at a higher risk of bleeding while taking axitinib. Contact your care team if you notice frequent nose bleeds, blood in your stool, bleeding that occurs by itself without injury, or bleeding that will not stop after five minutes of pressure. Axitinib can increase your risk of having a blood clot. Seek immediate medical attention if you have sudden swelling in an arm or leg, chest pain, or trouble breathing.AXITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because axitinib 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 axitinib, 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 axitinib 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 axitinib. 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 axitinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking axitinib and for one month after the last dose of axitinib. 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 axitinib.AXITINIB 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. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.inlyta.com Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=759 Product resources: www.inlyta.com/cancer resources Updated – June 7, 2021 Additional instructions

Inqovi®

(in-KOH-vee)

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

Inqovi® (Decitabine and Cedazuridine) 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.

Inrebic®

(inn-REH-bik)

Inrebic® (fedratinib) is used to treat myelofibrosis.

Inrebic® (fedratinib) is used to treat myelofibrosis.

Page 1 FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name fedratinib (fed RA ti nib) Brand name Inrebic® (inn REH bik) Approved uses Fedratinib is used to treat myelofibrosis. Dose and schedule Taking fedratinib 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 fedratinib is 400 milligrams (400 mg) to be taken by mouth at a scheduled time once a day. Fedratinib can be taken with or without food, but at the same time each day. Fedratinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow fedratinib, talk to your care provider or pharmacist for possible options. If you miss a dose of fedratinib, 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 Fedratinib 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 fedratinib; avoid eating or drinking this during treatment with fedratinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle fedratinib 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 fedratinib at room temperature (68°F–77°F) in a dry location away from light. Keep fedratinib out of reach of children and pets. Leave fedratinib in the provided packaging until it is ready to be taken. Whenever possible, you should give fedratinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the fedratinib 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 fedratinib from its package to a small medicine or other disposable cup. FEDRATINIB 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 provider 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 Fedratinib Below are common side effects that have been known to happen in about one third or more of patients taking fedratinib; 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 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 FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Unusual swelling in your legs and feet Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, notice blood in your urine or stool, cough up blood, or have prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page FEDRATINIB 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 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. Changes in electrolytes and other laboratory values High pancreas enzyme 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 Serious side effects Fedratinib may cause a serious and sometimes fatal brain problem called encephalopathy (including Wernicke encephalopathy). Wernicke encephalopathy is a medical emergency and can happen if you do not have enough vitamin B1 (thiamine) in your body. You care team will do a blood test to check your vitamin B1 levels before starting and during treatment with fedratinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Handling body fluids and waste Since fedratinib 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 fedratinib, 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 fedratinib 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 There are no scientific data on the safety of fedratinib during pregnancy. Discuss with your healthcare team before using fedratinib if you plan to become pregnant or get a partner pregnant, or if you are pregnant or breastfeeding. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your fedratinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212327s000lbl.pdf Updated – October 30, 2019 FEDRATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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. Additional instructions

Iressa®

(i-REH-suh)

Iressa® (Gefitinib) is used to treat adults with metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor receptor (EGFR).

Iressa® (Gefitinib) is used to treat adults with metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor receptor (EGFR).

Page 1 GEFITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — gefitinib geh FIH tih nib Brand name — Iressa® i REH suh Approved uses Gefitinib is used to treat adults with metastatic non small cell lung cancer NSCLC that has a genetic mutation called epidermal growth factor receptor EGFR . Dose and schedule Taking gefitinib 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 gefitinib is 250 milligrams 250 mg to be taken by mouth at a scheduled time once a day. Gefitinib can be taken with or without food at the same time each day. Gefitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow gefitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of gefitinib: – 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 the missed dose if it has been more than 12 hours since you should have taken it. Simply take your 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 notify your care provider about any missed doses. Storage and handling Handle gefitinib 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 gefitinib at room temperature 68°F–77°F in a dry location away from light. Keep gefitinib out of reach of children and pets. Leave gefitinib in the provided packaging until it is ready to be taken. Whenever possible, you should give gefitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the gefitinib 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 gefitinib 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. GEFITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for gefitinib. Do not mix other medications into the box with gefitinib. 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 gefitinib, 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 gefitinib. If you are traveling, put your gefitinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Gefitinib 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 gefitinib, 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 gefitinib 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 Gefitinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with gefitinib, so avoid eating or drinking these during treatment with gefitinib. Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines. GEFITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Gefitinib The common side effects that have been known to happen in more than 30% of patients taking gefitinib 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 Acne like rash A rash that looks like acne may develop on your face, chest, and upper back while taking this medication. Your doctor may prescribe medication to help prevent or manage the rash. If you do get a rash, keep the surrounding area clean and dry. Check with your care provider before using anything to treat the rash. Do not use over the counter acne treatments, such as benzoyl peroxide or salicylic acid, or soaps containing alcohol. Oatmeal baths and unscented moisturizers may help with itching. Sunlight can make symptoms worse. – Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV ultraviolet radiation occurs from the hours of 10 am through 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 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 Kidney damage Your care provider will monitor your kidney function by checking the amount of protein in your urine. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO GEFITINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking gefitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of gefitinib. Do not breastfeed while taking gefitinib and for two weeks after the last dose of gefitinib. Inform your care provider if you become pregnant. It is safe to hug and kiss, but special precautions may be needed for sexual activity while on oral chemotherapy. You are encouraged to talk to your care provider. Obtaining medication Talk with your care provider about how to obtain your gefitinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.iressa usa.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2015/206995s000lbl.pdf Product resources: www.iressa usa.com/lung cancer support/nsclc resources.html Updated – February 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.

Ivosidenib

(I-voh-SIH-deh-nib)

Ivosidenib is used to treat patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH-1) mutation. Ivosidenib is also used to treat patients with cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH-1) mutation.

Ivosidenib is used to treat patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH-1) mutation. Ivosidenib is also used to treat patients with cholangiocarcinoma with an isocitrate dehydrogenase-1 (IDH-1) mutation.

Page 1 IVOSIDENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ivosidenib (I voh SIH deh nib) Brand name — Tibsovo® (tib SOH voh) Approved uses Ivosidenib is used to treat patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 1 (IDH 1) mutation. Ivosidenib is also used to treat patients with cholangiocarcinoma with an isocitrate dehydrogenase 1 (IDH 1) mutation. Dose and schedule Taking ivosidenib 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 ivosidenib is 500 milligrams (500 mg) to be taken by mouth at a scheduled time once a day. Ivosidenib can be taken with or without food but at the same time each day. Avoid consuming a high fat meal while taking a dose of ivosidenib. Ivosidenib should be swallowed whole. Do not crush, cut, or dissolve the tablet. If you are unable to swallow ivosidenib, talk to your care provider or pharmacist for possible options. If you vomit immediately after taking ivosidenib, do not take a replacement dose. Wait until the next scheduled dose. If a dose of ivosidenib is missed, take a dose as soon as possible, as long as it is at least 12 hours prior to the next scheduled dose. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle ivosidenib 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 ivosidenib at room temperature (68°F–77°F) in a dry location away from light. Keep ivosidenib out of reach of children and pets. Whenever possible, you should give ivosidenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ivosidenib 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 ivosidenib 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. IVOSIDENIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for ivosidenib. Do not mix other medications into the box with ivosidenib. 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 ivosidenib, 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 ivosidenib. If you are traveling, put your ivosidenib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Ivosidenib remains in your body for several days after it is taken, and some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take ivosidenib, 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 ivosidenib 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 Ivosidenib 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 ivosidenib; avoid eating or drinking these during treatment with ivosidenib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Ivosidenib can cause differentiation syndrome, which is a condition that affects your blood cells and may be lifethreatening. Differentiation syndrome has happened as early as one day and up to three months after starting ivosidenib. Call your healthcare provider or go to the nearest emergency room right away if you develop any of the following symptoms of differentiation syndrome while taking ivosidenib: fever, cough, trouble breathing, rash, decreased urination, dizziness or lightheadness, rapid weight gain, and swelling of your arms or legs. IVOSIDENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ivosidenib The common side effects that have been known to happen in more than 30% of patients taking ivosidenib 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 electrolytes and other laboratory values • Increased white blood cell count (leukocytosis) • Increased uric acid levels • Low magnesium levels • Low potassium levels • Low sodium 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 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 IVOSIDENIB 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/fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (such as bananas, applesauce, potatoes, chicken, rice, and toast). • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by four or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. 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 IVOSIDENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Fluid retention or swelling • Do not stand for long periods of time. • Keep your legs elevated when sitting or lying down. • Try not to eat salty foods, which can increase swelling. • Avoid tight fitting clothing and shoes. • Weigh yourself daily. Contact your provider if you notice any of the following: • Swelling in the hands, feet, or legs • Shortness of breath • Weight gain of five pounds or more in one week 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 it is okay to rest as needed. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider what you may use to help with this discomfort. Take only pain medication that has been prescribed or recommended by your care provider. 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 ivosidenib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of ivosidenib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of one month after the last dose of ivosidenib. Do not breastfeed while taking ivosidenib and for one month after the last dose of ivosidenib. 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. IBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 IVOSIDENIB ORAL CHEMOTHERAPY EDUCATION Obtaining medication Talk with your care provider about the process for obtaining your ivosidenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.tibsovo.com Product prescribing information: www.tibsovo.com/pdf/prescribinginformation.pdf Product resources: 1 844 409 1141 Updated – July 31, 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.

Ixazomib

(ik-SA-zoh-mib)

Ixazomib (Ninlaro®) is used to treat multiple myeloma (MM) in combination with lenalidomide and dexamethasone.

Ixazomib (Ninlaro®) is used to treat multiple myeloma (MM) in combination with lenalidomide and dexamethasone.

Page 1 IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — ixazomib ik SA zoh mib Brand name — Ninlaro® nin LAR oh Approved uses Ixazomib is used to treat multiple myeloma MM in combination with lenalidomide and dexamethasone. Dose and schedule Taking ixazomib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. While capsules come in different strengths 4 mg, 3 mg, and 2.3 mg , the usual dose of ixazomib is 4 milligrams 4 mg to be taken by mouth at a scheduled time once weekly for 3 weeks, followed by a 1 week break i.e., on days 1, 8, and 15 of a 28 day cycle . Ixazomib should be taken on an empty stomach at least 1 hour before or 2 hours after a meal or snack , but at the same time of day. Ixazomib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow ixazomib, talk to your care provider or pharmacist for possible options. If you miss a dose of ixazomib: Only take the missed dose if the next scheduled dose is at least 72 hours 3 days away. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it is within 72 hours 3 days of the next scheduled dose. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle ixazomib 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 ixazomib at room temperature 68°F to 77°F in a dry location away from light. Keep ixazomib out of reach of children and pets. Leave ixazomib in the provided packaging until it is ready to be taken. Whenever possible, you should give ixazomib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the ixazomib 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 ixazomib from its package to a small medicine or other disposable cup. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box is not recommended to be used with ixazomib. If you have any unused ixazomib, 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 ixazomib. If you are traveling, ask your pharmacist, nurse, or healthcare provider if any additional travel precautions are needed as capsules are to remain in the packaging. Handling body fluids and waste Since ixazomib 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 ixazomib, 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 ixazomib 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 Ixazomib has many drug interactions, please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Ixazomib 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. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Ixazomib The common side effects that have been known to happen in more than 30% of patients taking ixazomib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, 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. 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 such as: 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. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 4 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 ixazomib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 90 days after the last dose of ixazomib. Women using hormonal contraceptives should also use a barrier method of contraception. Do not breastfeed while taking ixazomib and for 90 days after the last dose of ixazomib. Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. 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. A daily stool softener, such as docusate Colace® , and/or laxative, such as senna Senakot® , may be helpful. If these do not help within 48 hours, tell your provider. IXAZOMIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your ixazomib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.ninlaro.com Product prescribing information: https://www.ninlaro.com/prescribing information.pdf Product resources: https://www.ninlaro.com/financial resources Updated – March 14, 2018 Additional instructions

Jakafi®

(JA-kah-fy)

Jakafi® (Ruxolitinib) is used to treat patients with myelofibrosis, polycythemia vera, and graft-versus-host disease.

Jakafi® (Ruxolitinib) is used to treat patients with myelofibrosis, polycythemia vera, and graft-versus-host disease.

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