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Belzutifan

(bel-ZOO-tih-fan)

Belzutifan (Welireg®) is used to treat renal cell carcinoma, central nervous system hemangioblastoma, or pancreatic neuroendocrine tumor caused by von Hippel-Lindau disease.

Belzutifan (Welireg®) is used to treat renal cell carcinoma, central nervous system hemangioblastoma, or pancreatic neuroendocrine tumor caused by von Hippel-Lindau disease.

Page 1 Name of your medication Generic name — Belzutifan (bel-ZOO-tih-fan) Brand name — Welireg® (WEL-ih-reg) Approved uses Belzutifan is used to treat renal cell carcinoma, central nervous system hemangioblastoma, or pancreatic neuroendocrine tumor caused by von Hippel-Lindau disease. Dose and schedule Taking belzutifan as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o Your dose may vary, but the usual dose of belzutifan is 120 milligrams (120 mg) to be taken by mouth at a scheduled time once a day. o Belzutifan can be taken with or without food, but at the same time each day. o Belzutifan should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow belzutifan, talk to your care provider or pharmacist for possible options. o If you miss a dose of belzutifan, take it as soon as possible on the same day and resume the regular daily dose schedule the next day. Do not take an extra dose or 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. o If vomiting occurs after taking belzutifan, do not retake the dose. Take the next dose on the next day at the regularly scheduled time. Drug and food interactions o Belzutifan has many drug interactions. Inform your care providers of all prescription medications, over-the-counter medications, vitamins, and herbal products. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle belzutifan with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. o Store belzutifan at room temperature (68°F–77°F) in a dry location away from light. o Keep belzutifan out of reach of children and pets. o Leave belzutifan in the provided packaging until it is ready to be taken. o Whenever possible, you should give belzutifan to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the belzutifan to you, they also need to follow these steps: 1. Wash hands with soap and water. BELZUTIFAN ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Belzutifan Below are common side effects that have been known to happen in about one-third or more of patients taking belzutifan 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 OK to rest as needed. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations 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. Continued on the next page 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the belzutifan 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. o 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. Page 3 Serious side effects o Belzutifan can cause serious birth defects. Do not take belzutifan if you are pregnant or think you might be pregnant. o Belzutifan can lower your white blood cells and your platelets, increasing your risk of infection and bleeding. o Bone marrow suppression is a decrease in the number of white blood cells, red blood cells, and platelets that can be severe with belzutifan. 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. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Because belzutifan 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 belzutifan, it is important to follow the instructions below every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. o Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low-flow toilet, close the lid and flush twice to ensure all waste has been discarded. Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if you headache has any of the following characteristics: • Follows a head injury • Is severe or starts suddenly • Does not go away after three 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 Nausea • 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. Page 4 • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. o If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. o If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. o Wash any skin that has been exposed to body waste or belzutifan with soap and water. o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception o Women should not become pregnant and men should not get a partner pregnant while taking belzutifan. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of one week after the last dose of belzutifan. o Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. o Do not breastfeed while taking belzutifan and for one week after the last dose of belzutifan. o Inform your care provider if you become pregnant. o It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication o Talk with your care provider about the process for obtaining your belzutifan. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.welireg.com Product prescribing information: www.merck.com/product/usa/pi_circulars/w/welireg/welireg_pi.pdf Product resources: www.merckaccessprogram-welireg.com/hcp/ Updated – September 12, 2021 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Bexarotene

bek-SAYR-uh-teen

Bexarotene (Targretin®) is used to treat people with cutaneous T-cell lymphomas.

Bexarotene (Targretin®) is used to treat people with cutaneous T-cell lymphomas.

Page 1 BEXAROTENE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name bexarotene (bek SAYR uh teen) Brand name Targretin® (tar GREH tin) Approved uses Bexarotene is used to treat people with cutaneous T cell lymphomas. Dose and schedule Taking bexarotene 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 bexarotene is 300 milligrams (300 mg) to 750 milligrams (750 mg) to be taken by mouth at a scheduled time once daily. Bexarotene should be taken with food with a full glass of water and at the same time each day. Bexarotene should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow bexarotene, talk to your care provider or pharmacist for possible options. If you miss a dose of bexarotene, 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 bexarotene 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 bexarotene at 36°F in a dry location away from light. Keep bexarotene out of reach of children and pets. Leave bexarotene in the provided packaging until it is ready to be taken. Whenever possible, you should give bexarotene to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the bexarotene 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 bexarotene 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. BEXAROTENE ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for bexarotene. Do not mix other medications into the box with bexarotene. 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 bexarotene, 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 bexarotene. If you are traveling, put your bexarotene in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since bexarotene 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 bexarotene, 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 bexarotene 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 Bexarotene has many drug interactions. Please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Avoid taking concurrent vitamin A without approval. Avoid concurrent gemfibrozil (Lopid®) with bexarotene. Grapefruit or grapefruit juice may interact with bexarotene; avoid eating or drinking these during treatment with bexarotene. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. BEXAROTENE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Bexarotene The common side effects that have been known to happen in more than 30% of patients taking bexarotene 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 High cholesterol High triglycerides Low thyroid hormone 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 Constipation Dry hair Slow heart rate Unexplained weight gain Headache Ask your provider what you may use to help with this discomfort. Contact your 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 three 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 Continued on the next page BEXAROTENE 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: 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. 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. Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. BEXAROTENE ORAL CHEMOTHERAPY EDUCATION Page 5 Serious side effects Bexarotene may be harmful to your pancreas. Speak to your care provider to know when you need to have laboratory tests done to monitor your pancreas. Seek medical attention if you have severe abdominal pain or tenderness, fever, or vomiting. Bexarotene may cause liver problems. Contact your care provider if you notice yellowing of the skin or whites of your eyes, dark or brown urine, or unusual bleeding or bruising. This medication may cause vision changes, such as cataracts. Report any changes in eyesight to 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 must not become pregnant and men should not get a partner pregnant while taking bexarotene. Female patients with reproductive potential must use effective contraception for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy. In addition, two reliable forms of contraception should be used simultaneously, one of which should be non hormonal. Male patients with sexual partners who are pregnant, possibly pregnant, or who could become pregnant must use condoms during sexual intercourse while taking bexarotene and for at least one month after the last dose of the drug. Do not breastfeed while taking bexarotene and for one month after the last dose of bexarotene. Please inform your care provider if you become pregnant. You should stop taking bexarotene immediately 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 bexarotene. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: http://targretin.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2011/021055s006lbl.pdf Product resources: http://targretin.com/coupon eligibility Updated – August 9, 2018 BEXAROTENE ORAL CHEMOTHERAPY EDUCATION Page 6 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Bicalutamide

(bye-ka-LOO-ta-mide)

Bicalutamide (Casodex®) is used to treat prostate cancer.

Bicalutamide (Casodex®) is used to treat prostate cancer.

ShowAll Page1BICALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — bicalutamide bye-ka-LOO-ta-mide Brand name — Casodex® ka-soh-dex Approved uses Bicalutamide is used to treat prostate cancer Dose and schedule Taking bicalutamide as instructed is important to allow your treatment to be as effective as possible so here are some key points to remember o Your dose may vary but the usual dose of bicalutamide is 50 mg to be taken by mouth at a scheduled time once a day o Bicalutamide can be taken with or without food o Bicalutamide should be taken whole and not crushed cut or dissolved If you are unable to swallow bicalutamide talk to your care provider or pharmacist for possible options o If you miss a dose of bicalutamide 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 bicalutamide with care Just like when chemotherapy is given into the vein this drug can be toxic and exposure of the drug to others should be limited o Store bicalutamide at room temperature 68°F–77°F in a dry location away from light o Keep bicalutamide out of reach of children and pets o Leave bicalutamide in the provided packaging until it is ready to be taken o Whenever possible give bicalutamide to yourself and follow the steps below If a family member friend or caregiver needs to give bicalutamide 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 bicalutamide 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 BICALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for bicalutamide Do not mix other medications into the box with bicalutamide The person filling the box or reminder should wear gloves Gloves are not necessary if you are filling the box or reminder When empty the box or reminder should be washed with soap and water before refilling Be sure to wash hands with soap and water after the task is complete whether or not gloves are worn o If you have any unused bicalutamide 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 bicalutamide o If you are traveling put your bicalutamide in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Bicalutamide 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 bicalutamide it is important to follow the instructions below every day for as long as your treatment lasts This will keep yourself loved ones and the environment as safe as possible o Pregnant women should avoid touching anything that may be soiled with body fluids from the patient o Toilet and septic systems You may use the same toilet septic tank and/or sewer that you usually use If you have a low-flow toilet close the lid and flush twice to ensure all waste has been discarded If the toilet or toilet seat becomes soiled with urine stool or vomit clean the surfaces before other people use the toilet Wash hands with soap and water after using the toilet o If you need a bedpan be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day o If you do not have good control of bladder or bowels use a disposable pad with a plastic back a diaper or a sheet to absorb body waste o Wash any skin that has been exposed to body waste or bicalutamide with soap and water o Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing If you do not have a washer place the soiled linens in a plastic bag until they can be washed o Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids Drug and food interactions o Bicalutamide has many drug interactions Inform your care providers of all prescription medications over-the-counter medications vitamins and herbal products that you are taking o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines BICALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Bicalutamide The common side effects that have been known to happen in more than 30% of patients taking bicalutamide are listed in the left side of this table You MAY NOT experience these side effects Options to help manage any side effects that do occur are included on the right side of this table These should be discussed with your care provider If you experience any side effect you cannot manage or that is not listed here contact your care provider Possible Side Effect Management Hot flashes sudden sweating and feelings of warmth If hot flashes are bothersome: Mild regular exercise may help Consult first with your care provider Try staying in a cool environment Wear layers so that if you experience a hot flash the outer layers may be removed Avoid or limit caffeine spicy food alcohol and stress which may cause hot flashes to worsen Inform your care provider if this side effect is bothersome as there may be medications that can help with hot flashes Pain Keep a diary of your pain including a description of when and where the pain is occurring what it feels like and how long it lasts Stay as active as possible but know that it is okay to rest as needed too Tell your care provider if pain interferes with your activity If the pain bothers you ask your provider what you may use to help with this discomfort Take only pain medication that has been prescribed or recommended by your care provider If you experience ANY uncontrolled side effect call your physician or healthcare center immediately: _ INSTITUTIONAL CONTACT INFO Pregnancy sexual activity and contraception o Women should not become pregnant and men should not get a partner pregnant while taking bicalutamide 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 bicalutamide o Inform your care provider if you become pregnant o It is safe to hug and kiss Special precautions may be needed for sexual activity while on bicalutamide and you are encouraged to ask your care provider Obtaining medication Talk with your care provider about how to obtain your bicalutamide PHARMACY OR SPECIALTY PHARMACY CONTACT INFO BICALUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 Additional resources Bicalutamide drug information: https://medlineplus gov/druginfo/meds/a697047 html Product prescribing information: www accessdata fda gov/drugsatfda_docs/label/2005/020498s016lbl pdf Updated – August 6 2017 Additional instructions Important notice: The Association of Community Cancer Centers ACCC Hematology/Oncology Pharmacy Association HOPA National Community Oncology Dispensing Association Inc NCODA and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources This guide does not cover all existing information related to the possible uses directions doses precautions warnings interactions adverse effects or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional Provision of this guide is for informational purposes only and does not constitute or imply endorsement recommendation or favoring of this medication by ACCC HOPA NCODA or ONS who assume no liability for and cannot ensure the accuracy of the information presented The collaborators are not making any representations with respect to the medications whatsoever and any and all decisions with respect to such medications are at the sole risk of the individual consuming the medication All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise easy-to-understand information about oral cancer drugs Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information However commercial reproduction or reuse as well as rebranding or reposting of any type are strictly prohibited without permission of the copyright holder Please email permission requests and licensing inquiries to Contact@NCODA org Copyright © 2017 by Hematology/Oncology Pharmacy Association All rights reserved

Bosulif®

(BAH-soo-lif)

Bosulif® (Bosutinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Bosulif® (Bosutinib) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Page 1 BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — bosutinib (bah SOO tih nib) Brand name — Bosulif® (BAH soo lif) Approved uses Bosutinib is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dose and schedule Taking bosutinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual adult dose of bosutinib is 400 milligrams (400 mg) to 500 milligrams (500 mg) to be taken by mouth at a scheduled time once a day. Bosutinib should be taken with food at the same time each day. Bosutinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow bosutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of bosutinib: • Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Bosutinib 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. Medications that decrease stomach acid decrease bosutinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), separate from bosutinib by more than two hours. Grapefruit or grapefruit juice may interact with bosutinib; avoid eating or drinking these during your treatment with bosutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle bosutinib 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 bosutinib at room temperature (68°F–77°F) in a dry location away from light. Keep bosutinib out of reach of children and pets. Leave bosutinib in the provided packaging until it is ready to be taken. Whenever possible, give bosutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give bosutinib 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 bosutinib 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 bosutinib, 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 bosutinib. If you are traveling, put your bosutinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Bosutinib Below are common side effects that have been known to happen in about one third or more of patients taking bosutinib 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, 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 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 pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am–4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on the bottle. • Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of your pancreas (pancreatitis). Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection 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 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 Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Serious side effects of bosutinib Be aware of changes in the electrical activity of your heart, called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking bosutinib o You may have diarrhea, nausea, vomitting, or abdominal pain while you are taking bosutinib. Tell your doctor right away if these side effects continue for more than a day. o You may be at a higher risk of bleeding while taking bosutnib. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. o Bosutinib 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. o Bosutinib may be harmful to your kidneys. Speak to your care provider to know when you need to have laboratory tests done to monitor your kidneys. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since bosutinib 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 bosutinib, 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. Possible Side Effect Management Fever You may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if you have a fever of 100.4°F or greater. Ask your doctor if you can take medicine to help with the fever. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know that 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 heavy machinery if you feel too tired. Cough A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 bosutinib 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 bosutinib. 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 bosutinib. o Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking bosutinib and for one month after the last dose of bosutinib. 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 bosutinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your bosutinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.bosulif.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2012/203341lbl.pdf Product resources: https://www.bosulif.com/resources Updated — June 7, 2021BOSUTINIB 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Bosutinib

(bah-SOO-tih-nib)

Bosutinib (Bosulif®) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Bosutinib (Bosulif®) is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+).

Page 1 BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — bosutinib (bah SOO tih nib) Brand name — Bosulif® (BAH soo lif) Approved uses Bosutinib is used to treat adults with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dose and schedule Taking bosutinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual adult dose of bosutinib is 400 milligrams (400 mg) to 500 milligrams (500 mg) to be taken by mouth at a scheduled time once a day. Bosutinib should be taken with food at the same time each day. Bosutinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow bosutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of bosutinib: • Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Bosutinib 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. Medications that decrease stomach acid decrease bosutinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), separate from bosutinib by more than two hours. Grapefruit or grapefruit juice may interact with bosutinib; avoid eating or drinking these during your treatment with bosutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle bosutinib 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 bosutinib at room temperature (68°F–77°F) in a dry location away from light. Keep bosutinib out of reach of children and pets. Leave bosutinib in the provided packaging until it is ready to be taken. Whenever possible, give bosutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give bosutinib 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 bosutinib 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 bosutinib, 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 bosutinib. If you are traveling, put your bosutinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Bosutinib Below are common side effects that have been known to happen in about one third or more of patients taking bosutinib 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, 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 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 pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am–4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on the bottle. • Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Abdominal pain Abdominal pain/discomfort may occur. Report any serious pain or symptoms to your care provider immediately. If these side effects occur with nausea and vomiting, you might have inflammation of your pancreas (pancreatitis). Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection 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 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 Changes in liver function Your liver function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Continued on the next pageBOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Serious side effects of bosutinib Be aware of changes in the electrical activity of your heart, called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking bosutinib o You may have diarrhea, nausea, vomitting, or abdominal pain while you are taking bosutinib. Tell your doctor right away if these side effects continue for more than a day. o You may be at a higher risk of bleeding while taking bosutnib. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. o Bosutinib 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. o Bosutinib may be harmful to your kidneys. Speak to your care provider to know when you need to have laboratory tests done to monitor your kidneys. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since bosutinib 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 bosutinib, 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. Possible Side Effect Management Fever You may feel hot, cold and shivery, achy, or dizzy. This usually starts during the first month of therapy but could happen at any time. • Call your doctor immediately if you have a fever of 100.4°F or greater. Ask your doctor if you can take medicine to help with the fever. Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know that 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 heavy machinery if you feel too tired. Cough A cough that does not produce any mucous or congestion relief (dry cough) may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. BOSUTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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 bosutinib 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 bosutinib. 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 bosutinib. o Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking bosutinib and for one month after the last dose of bosutinib. 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 bosutinib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your bosutinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.bosulif.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2012/203341lbl.pdf Product resources: https://www.bosulif.com/resources Updated — June 7, 2021BOSUTINIB 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 © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Braftovi® and Mektovi®

((braf-TOH-vee) and (mek-TOH-vee))

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

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

Page 1 ENCORAFENIB AND BINIMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic names — encorafenib (EN kor A feh nib) and binimetinib (BIH nee MEH tih nib) Brand names — Braftovi® (braf TOH vee) and Mektovi® (mek TOH vee) Please make sure to follow the instructions on the side of the table that your provider has checked. Approved uses The combination of encorafenib and binimetinib is used to treat patients with melanoma that have a genetic mutation called BRAF V600E or V600K. Dose and schedule Taking encorafenib and binimetinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. For both encorafenib and binimetinib, do not take two doses at one time, and be sure to write down if you miss a dose and to let your care provider know about any missed doses. Do not take an additional dose of either medication if vomiting occurs after administration. Continue with the next scheduled dose. Both encorafenib and binimetinib can be taken with or without food, but at the same time each day. Encorafenib and binimetinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow encorafenib and binimetinib, talk to your care provider or pharmacist for possible options. Drug and food interactions Encorafenib and binimetinib have many drug interactions. Inform your care providers of all prescription medications, overthe counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with encorafenib; avoid eating or drinking these during treatment with encorafenib. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle encorafenib and binimetinib with care. Just like when chemotherapy is given into the vein, these drugs can be toxic, and exposure of the drugs to others should be limited. Store encorafenib and binimetinib at room temperature (68°F–77°F) in a dry location away from light. Usual dose: 450 mg (six 75 mg capsules) by mouth once daily If you miss a dose: Only take if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Usual dose: 45 mg (three 15 mg tablets) by mouth twice daily If you miss a dose: Only take if it has been less than 6 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Encorafenib Binimetinib ENCORAFENIB AND BINIMETINIBORAL CHEMOTHERAPY EDUCATION Page 2 ENCORAFENIB AND BINIMETINIB Keep out of reach of children and pets. Leave encorafenib and binimetinib in the provided packaging until it is ready to be taken. Whenever possible, you should give these medications to yourself and follow the steps below. If a family member, friend, or caregiver needs to give them to you, they also need to follow these steps: 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the medication from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or reminder may be used for binimetinib (but not for encorafenib, as it should be kept in the original packaging). Contact your care team before using a daily pill box. • The person filling the box or reminder should wear gloves (gloves are not necessary if you as the patient are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused encorafenib and binimetinib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of these medications. If you are traveling, put your medications in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.ORAL CHEMOTHERAPY EDUCATION Page 3 ENCORAFENIB AND BINIMETINIB Side Effects of Encorafenib and Binimetinib The common side effects that have been known to happen in more than 30% of patients taking encorafenib and binimetinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice either of the following: • Decreased amount of urination • Unusual swelling in your legs and feet Changes in electrolytes and other laboratory values • High creatine phosphokinase • High gamma glutamyl transferase Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed, too. • Try to do some activity every day. • Plan your activities and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Continued on the next pageORAL CHEMOTHERAPY EDUCATION Page 4 ENCORAFENIB AND BINIMETINIB Possible Side Effect Management Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake because of some other health problem. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is OK to rest as needed. • You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • PalpitationsORAL CHEMOTHERAPY EDUCATION Page 5 ENCORAFENIB AND BINIMETINIB Serious side effects You may be at a higher risk of bleeding while taking these medications. Be sure to seek medical attention right away if you have any major bleeding. Also be sure to check for any signs of bleeding in your stool. These medications may be harmful to your eyes. Be sure to inform your care provider of any issues you have with your vision or pain in your eyes. Your provider may stop treatment with either of these medications if your eyes are affected. The development of skin and non skin cancers have been observed in patients who have taken encorafenib. It is recommended that you perform a skin self examination prior to starting encorafenib and then every 2 months during treatment, and for up to 6 months following stopping encorafenib. Encorafenib may cause a condition called QT or QTc prolongation, which is a heart rhythm that can cause fast, irregular heartbeats. These fast heartbeats may cause you to faint or have a seizure. In rare cases, this could be life threatening. Tell your care team right away if you feel faint, lightheaded, or dizzy or if you feel your heart beating irregularly or fast while taking encorafenib. Binimetinib can increase your risk of a blood clot. Notify your healthcare provider right away if you notice any swelling or pain (especially with movement) in your arms or legs, as well as shortness of breath or chest pain. Binimetinib can make your heart work harder to pump blood to the rest of your body. Notify your healthcare provider if you experience shortness of breath or chest pain. Binimetinib may be harmful to your lungs. Inform your care provider of any new difficulty breathing, cough, or fever. Your provider may stop treatment with binimetinib if your lungs are affected. Binimetinib may be harmful to your liver. Seek medical attention if you notice yellowing of the skin or whites of your eyes, dark or brown urine, bleeding, or bruising. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since encorafenib and binimetinib remain in your body for several days after they are taken, some of these drugs may be present in urine, stool, sweat, or vomit. Once you have started to take these medications, it is important to follow these instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day.ORAL CHEMOTHERAPY EDUCATION Page 6 ENCORAFENIB AND BINIMETINIB If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or these medications with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking encorafenib and binimetinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 30 days after the last dose of these medications. o Discuss with your care provider about effective contraception during treatment as encorafenib has the potential to render hormonal contraceptives ineffective. These medications can interfere with hormonal contraception. Talk to your care team for more information. o Do not breastfeed while taking these medications and for 30 days after the last dose. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining encorafenib and binimetinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.braftovimektovi.com/hcp Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=12990 (encorafenib), http://labeling.pfizer.com/ShowLabeling.aspx?id=12988 (binimetinib) Product resources: https://www.braftovimektovi.com/patient support Updated – May 28, 2021 Additional instructions ORAL CHEMOTHERAPY EDUCATION Page 7 ENCORAFENIB AND BINIMETINIB Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved

Braftovi®

(braf-TOH-vee)

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

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

Page 1 ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — encorafenib (en koe RAF e nib) Brand name — Braftovi® (braf TOH vee) Approved uses Encorafenib is used to treat patients with: Metastatic colorectal cancer that has a genetic mutation called BRAF V600E mutation and is be used in combination with cetuximab. Dose and schedule Taking encorafenib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of encorafenib is 300 milligram (300 mg) to be taken by mouth at a scheduled time once a day. Encorafenib can be taken with or without food, but at the same time each day. Encorafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow encorafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of encorafenib, follow these guidelines: • Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Encorafenib has many drug interactions, please inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Grapefruit or grapefruit juice may interact with encorafenib; avoid eating or drinking these during treatment with encorafenib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle encorafenib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store encorafenib at room temperature (68°F to 77°F) in a dry location away from light. Keep encorafenib out of reach of children and pets. Leave encorafenib in the provided packaging until it is ready to be taken.ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Encorafenib Below are common side effects that have been known to happen in about one third or more of patients taking encorafenib are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is okay to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating heavy machinery if you feel too tired. Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page Whenever possible, you should give encorafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the encorafenib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the encorafenib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. A daily pill box or pill reminder is not recommended to be used with encorafenib. If you have any unused encorafenib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of encorafenib. If you are traveling, put your encorafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Serious side effects of encorafenib The development of skin and non skin cancers have been observed in patients who have taken encorafenib. It is recommended that you perform self skin exams prior to starting encorafenib and then every 2 months during treatment, and for up to 6 months following stopping encorafenib. Bleeding has been reported with encorafenib. Report any bleeding to your healthcare provider. Eye changes, which include redness, pain, and blurred vision, have been reported. Consult your doctor on how regularly you should get an eye exam. Be aware of changes in the electrical activity of your heart, called QT prolongation. Tell your healthcare provider right away if you feel faint, lightheaded, or dizzy, or if you feel your heart beating irregularly or fast, while taking encorafenib with binimetinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is okay to rest as needed. • You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Changes in kidney function Your kidney (renal) function will be checked periodically by a simple blood test. Contact your care provider if you notice either of the following: • Decreased amount of urination • Unusual swelling in your legs and feet Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruisingENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Handling body fluids and waste Since encorafenib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take encorafenib, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or encorafenib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking encorafenib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 2 weeks after the last dose of encorafenib. Discuss with your care provider about effective contraception during treatment as encorafenib has the potential to render hormonal contraceptives ineffective. Do not breastfeed while taking encorafenib and for 2 weeks after the last dose of encorafenib. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider.ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 ENCORAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Obtaining medication Talk with your care provider about the process for obtaining your encorafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.braftovihcp.com Product prescribing information: http://labeling.pfizer.com/ShowLabeling.aspx?id=12990 Product resources: https://www.braftovihcp.com/access and support Updated – May 28, 2021 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved

Brigatinib

(brih-GA-tih-nib)

Brigatinib (Alunbrig®) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called anaplastic lymphoma kinase (ALK).

Brigatinib (Alunbrig®) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a genetic mutation called anaplastic lymphoma kinase (ALK).

Page 1 BRIGATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — brigatinib brih GA tih nib Brand name — Alunbrig® uh LUN brig Approved uses Brigatinib is used to treat metastatic non small cell lung cancer NSCLC that has a genetic mutation called anaplastic lymphoma kinase ALK . Dose and schedule Taking brigatinib 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 brigatinib is 90 milligrams 90 mg to be taken by mouth at a scheduled time, once a day for the first seven days. Then, the dose may increase to 180 milligrams 180 mg to be taken by mouth at a scheduled time, once a day. Brigatinib can be taken with or without food, but at the same time each day. Brigatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow brigatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of brigatinib, 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 brigatinib 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 brigatinib at room temperature 68°F–77°F in a dry location away from light. Keep brigatinib out of reach of children and pets. Leave brigatinib in the provided packaging until it is ready to be taken. Whenever possible, you should give brigatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the brigatinib 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 brigatinib 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. BRIGATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for brigatinib. Do not mix other medications into the box with brigatinib. 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 brigatinib, 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 brigatinib. If you are traveling, put your brigatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since brigatinib 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 brigatinib, it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or brigatinib 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 Brigatinib 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 brigatinib; avoid eating or drinking these during treatment with brigatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. BRIGATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Brigatinib The common side effects that have been known to happen in more than 30% of patients taking brigatinib 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 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 Unusual bleeding or bruising Changes in electrolytes and other laboratory values High glucose levels High creatine phosphokinase levels High lipase levels High amylase 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 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 BRIGATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Diarrhea lose 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, 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. Cough or shortness of breath A cough that does not produce any mucous or congestion relief dry cough may occur while taking this medication. If you experience any breathing problems or shortness of breath, notify your care provider immediately. This may be a serious side effect of the medication. BRIGATINIB 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 brigatinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of brigatinib. Men with female partners of childbearing age and potential should use effective contraception during therapy and for a minimum of three months after the last dose of brigatinib. Do not breastfeed while taking brigatinib and for one week after the last dose of brigatinib. 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 brigatinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.alunbrig.com Product prescribing information: www.alunbrig.com/assets/pi.pdf Product resources: www.ariadpass.com/patient alunbrig.html Updated – November 6, 2017 Additional instructions BRIGATINIB 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 © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Brukinsa®

(BROO-kin-sah)

Brukinsa® (Zanubrutinib) is used to treat mantle cell lymphoma (MCL), Waldenströms macroglobulinemia (MW), and marginal zone lymphoma (MZL).

Brukinsa® (Zanubrutinib) is used to treat mantle cell lymphoma (MCL), Waldenströms macroglobulinemia (MW), and marginal zone lymphoma (MZL).

Page 1 ZANUBRUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — zanubrutinib (ZAN ue BROO ti nib) Brand name — Brukinsa® (BROO kin sah) Approved uses Zanubrutinib is used to treat mantle cell lymphoma (MCL). Dose and schedule Taking zanubrutinib 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 zanubrutinib is 160 milligrams (160 mg) to be taken by mouth at a scheduled time twice a day OR 320 milligrams (320 mg) to be taken by mouth at a scheduled time once a day. Zanubrutinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow zanubrutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of zanubrutinib, remember the following guidelines: • Only take the missed dose as soon as you remember it on the same day. • Do not take two doses at one time. • Be sure to write down if you miss a dose, and let your care provider know about any missed doses. Drug and food interactions Zanubrutinib 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 zanubrutinib; avoid eating or drinking this during treatment with zanubrutinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle zanubrutinib 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 zanubrutinib at room temperature (68°F–77°F) in a dry location away from light. Keep zanubrutinib out of reach of children and pets. Leave zanubrutinib in the provided packaging until it is ready to be taken. Whenever possible, you should give zanubrutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the zanubrutinib 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.) ZANUBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the zanubrutinib 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, contact your care team before using. • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. Side Effects of Zanubrutinib Below are common side effects that have been known to happen in about one third or more of patients taking zanubrutinib; 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 ZANUBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 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. 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. 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. Continued on the next page ZANUBRUTINIB 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 Serious side effects Zanubrutinib can cause serious birth defects. Do not take zanubrutinib if you are pregnant or think you might be pregnant. Zanubrutinib may cause arrhythmias, which are problems with your heartbeat. Call your care team right away if you feel a change in the way your heart beats. Secondary malignancy is the growth of a cancer, including skin cancer, months or years after treatment. This is a rare but possible side effect of treatment with zanubrutinib. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since zanubrutinib 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 zanubrutinib, 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. ZANUBRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 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 zanubrutinib 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 zanubrutinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of zanubrutinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking zanubrutinib and for 2 weeks after the last dose of zanubrutinib. 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 zanubrutinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.brukinsa.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/213217s000lbl.pdf Product resources: https://www.brukinsa.com/patient support Updated – November 18, 2019 Additional instructions ZANUBRUTINIB 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.

Cabometyx™

(ka-boe-MET-iks)

Cometriq® (Cabozantinib)is used to treat patients with advanced kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma) and those with progressive, metastatic medullary thyroid cancer.

Cometriq® (Cabozantinib) is used to treat patients with advanced kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma) and those with progressive, metastatic medullary thyroid cancer.

Page 1 Cabometyx ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — cabozantinib KA boe ZAN ti nib Brand name — Cabometyx™ for kidney cancer; ka boe MET iks ; Cometriq® for thyroid cancer; CO met rik Approved uses Cabozantinib is used to treat patients with advanced kidney cancer renal cell carcinoma and those with progressive, metastatic medullary thyroid cancer. Dose and schedule Taking cabozantinib 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 cabozantinib is: 60 milligrams 60 mg to be taken by mouth at a scheduled time once a day for kidney cancer 140 milligrams 140 mg to be taken by mouth at a scheduled time once a day for thyroid cancer Cabozantinib should be taken on an empty stomach do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib at the same time each day. Do not substitute cabozantinib tablets with cabozantinib capsules. Cabozantinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow cabozantinib, talk to your care provider or pharmacist for possible options. If you miss a dose of cabozantinib, 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 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. If you need to have surgery, tell your care provider you are taking cabozantinib. Cabozantinib may need to be stopped until your wound heals after some surgeries. Storage and handling Handle cabozantinib 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 cabozantinib at room temperature 68°F–77°F in a dry location away from light. Keep cabozantinib out of reach of children and pets. Leave cabozantinib in the provided packaging until it is ready to be taken. Whenever possible, give cabozantinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give cabozantinib 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. CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the cabozantinib 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 cabozantinib. Do not mix other medications into the box with cabozantinib. 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 cabozantinib, 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 cabozantinib. If you are traveling, put your cabozantinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because cabozantinib 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 cabozantinib, 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 cabozantinib 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. CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Drug and food interactions Cabozantinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Cabozantinib should be taken without food do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib . Grapefruit or grapefruit juice may interact with cabozantinib; avoid eating or drinking these during treatment with cabozantinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects of cabozantinib Cabozantinib that is taken for thyroid cancer can increase your risk of developing gastrointestinal fistulas and perforations holes to occur. Cabozantinib that is taken for thyroid cancer can increase your risk of bleeding. Side Effects of Cabozantinib The common side effects that have been known to happen in more than 30% of patients taking cabozantinib 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 will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. 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 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. Changes in electrolytes and other laboratory values Low calcium levels High triglyceride levels Low phosphate levels High glucose levels Low albumin levels Low magnesium levels Low sodium levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Continued on the next page CABOZANTINIB 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. Pain or discomfort in hands and/or feet Hand foot skin reaction HFSR appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. Exfoliate and keep hands and feet moisturized. Avoid tight fitting shoes or socks. Use cushioning i.e., gloves when performing activities that increase pressure on the palms of your hands. 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 . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 Unusualtiredness 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 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. Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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. Hair color changes Changes to your hair color may occur during treatment. The hair usually returns to normal after treatment, but for some, the change is permanent. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth with a soft bristle toothbrush before and after eating. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 8 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 cabozantinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of cabozantinib. Do not breastfeed while taking cabozantinib and for four months after the last dose of cabozantinib. 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 cabozantinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product websites: www.cometriq.com and www.cabometyx.com Product prescribing information: www.cometriq.com/downloads/Cometriq Full Prescribing Information.pdf and www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Product resources: www.cometriq.com/support and www.cabometyx.com/support Updated – October 1, 2017 CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 9 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Cabozantinib

(KA boe ZAN ti nib)

Cabozantinib (Cometriq® for thyroid cancer) or (Cabometyx™ for kidney and liver cancer) is used to treat patients with advanced kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma) and those with progressive, metastatic medullary thyroid cancer.

Cabozantinib (Cometriq® for thyroid cancer) or (Cabometyx™ for kidney and liver cancer) is used to treat patients with advanced kidney cancer (renal cell carcinoma), liver cancer (hepatocellular carcinoma) and those with progressive, metastatic medullary thyroid cancer.

Page 1 CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — cabozantinib KA boe ZAN ti nib Brand name — Cabometyx™ for kidney cancer; ka boe MET iks ; Cometriq® for thyroid cancer; CO met rik Approved uses Cabozantinib is used to treat patients with advanced kidney cancer renal cell carcinoma and those with progressive, metastatic medullary thyroid cancer. Dose and schedule Taking cabozantinib 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 cabozantinib is: 60 milligrams 60 mg to be taken by mouth at a scheduled time once a day for kidney cancer 140 milligrams 140 mg to be taken by mouth at a scheduled time once a day for thyroid cancer Cabozantinib should be taken on an empty stomach do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib at the same time each day. Do not substitute cabozantinib tablets with cabozantinib capsules. Cabozantinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow cabozantinib, talk to your care provider or pharmacist for possible options. If you miss a dose of cabozantinib, 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 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. If you need to have surgery, tell your care provider you are taking cabozantinib. Cabozantinib may need to be stopped until your wound heals after some surgeries. Storage and handling Handle cabozantinib 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 cabozantinib at room temperature 68°F–77°F in a dry location away from light. Keep cabozantinib out of reach of children and pets. Leave cabozantinib in the provided packaging until it is ready to be taken. Whenever possible, give cabozantinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give cabozantinib 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. CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 3. Gently transfer the cabozantinib 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 cabozantinib. Do not mix other medications into the box with cabozantinib. 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 cabozantinib, 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 cabozantinib. If you are traveling, put your cabozantinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Because cabozantinib 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 cabozantinib, 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 cabozantinib 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. CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Drug and food interactions Cabozantinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Cabozantinib should be taken without food do not eat for at least 2 hours before and at least 1 hour after taking cabozantinib . Grapefruit or grapefruit juice may interact with cabozantinib; avoid eating or drinking these during treatment with cabozantinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects of cabozantinib Cabozantinib that is taken for thyroid cancer can increase your risk of developing gastrointestinal fistulas and perforations holes to occur. Cabozantinib that is taken for thyroid cancer can increase your risk of bleeding. Side Effects of Cabozantinib The common side effects that have been known to happen in more than 30% of patients taking cabozantinib 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 will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods e.g., bananas, applesauce, potatoes, chicken, rice, toast . Avoid high fiber foods e.g., raw vegetables, raw fruits, whole grains . Avoid foods that cause gas e.g., broccoli, beans . Avoid lactose containing foods e.g., yogurt, milk . Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. 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 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. Changes in electrolytes and other laboratory values Low calcium levels High triglyceride levels Low phosphate levels High glucose levels Low albumin levels Low magnesium levels Low sodium levels Changes in some laboratory values may occur and should be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Continued on the next page CABOZANTINIB 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. Pain or discomfort in hands and/or feet Hand foot skin reaction HFSR appears on the palms of the hands and soles of the feet. It can appear as a rash, callus, or peeling skin, and the area has increased sensitivity to heat or a “pins and needles” sensation. Let your care provider know right away if you experience this side effect. To prevent HFSR, you can do the following: Soak your feet in a water bath with Epsom salt and gently pumice any callused skin. Exfoliate and keep hands and feet moisturized. Avoid tight fitting shoes or socks. Use cushioning i.e., gloves when performing activities that increase pressure on the palms of your hands. 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 . One example is a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm not hot water. If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased 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. Increased blood pressure Routinely take your blood pressure. Record your blood pressure in a journal/diary and report these to your physician. Contact your healthcare provider for high blood pressure or if the following symptoms occur: Headache Dizziness Chest pain Shortness of breath Fluid retention, weight gain, or swelling Continued on the next page CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 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. Hair color changes Changes to your hair color may occur during treatment. The hair usually returns to normal after treatment, but for some, the change is permanent. Taste changes Some people experience a metallic or bitter taste in their mouth. To help with taste changes, try the following: Choose and prepare foods that look and smell good to you. Use plastic utensils if food tastes like metal. Flavor foods with spices to change taste. Suck on mints or chew gum to mask taste. Brush teeth with a soft bristle toothbrush before and after eating. Avoid smoking. Notify your doctor if you are having trouble eating or are losing weight. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 8 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 cabozantinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of four months after the last dose of cabozantinib. Do not breastfeed while taking cabozantinib and for four months after the last dose of cabozantinib. 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 cabozantinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product websites: www.cometriq.com and www.cabometyx.com Product prescribing information: www.cometriq.com/downloads/Cometriq Full Prescribing Information.pdf and www.cabometyx.com/downloads/CABOMETYXUSPI.pdf Product resources: www.cometriq.com/support and www.cabometyx.com/support Updated – October 1, 2017 CABOZANTINIB ORAL CHEMOTHERAPY EDUCATION Page 9 Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional instructions

Calquence®

(KAL-kwents)

Calquence® (Acalabrutinib) is used to treat patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma

Calquence® (Acalabrutinib) is used to treat patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma

Page 1 ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — acalabrutinib (uh KA luh BROO tih nib) Brand name — Calquence® (KAL kwents) Approved uses Acalabrutinib is used to treat patients with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma Dose and schedule Taking acalabrutinib 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 acalabrutinib is 100 milligrams (100 mg) to be taken by mouth every 12 hours. The dose may be adjusted by your care provider based upon your individual needs. Acalabrutinib can be taken with or without food, but at the same time each day. Acalabrutinib should be taken whole and not crushed, cut, opened, or dissolved. If you are unable to swallow acalabrutinib, talk to your care provider or pharmacist for possible options. If you miss a dose of acalabrutinib, follow these guidelines: • Only take the missed dose if it has been less than three hours since you were supposed to take it. Then, take the next dose at the regularly scheduled time. • Do not take two doses at one time. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Acalabrutinib has the potential for 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 acalabrutinib. Avoid eating or drinking these during your treatment with acalabrutinib. Medications that decrease stomach acid decrease acalabrutinib concentrations. Avoid use with proton pump inhibitors (e.g., omeprazole [Prilosec®], esomeprazole [Nexium®]), if possible. If taken with a histamine blocker (e.g., ranitidine [Zantac®], famotidine [Pepcid®]), take acalabrutinib 10 hours after the histamine blocker and at least 2 hours prior to the next histamine blocker dose. Separate use of acalabrutinib from antacids by at least 2 hours. Talk with your care team or pharmacist before taking new medications or supplements, or receiving any vaccines. ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle acalabrutinib 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 acalabrutinib at room temperature (68°F–77°F) in a dry location away from light. Keep acalabrutinib out of reach of children and pets. Leave acalabrutinib in the provided packaging until it is ready to be taken. Whenever possible, give acalabrutinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the acalabrutinib 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 acalabrutinib 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 acalabrutinib, 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 acalabrutinib. If you are traveling, put your acalabrutinib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Acalabrutinib Below are common side effects that have been known to happen in about one third or more of patients taking acalabrutinib 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 Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 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 three 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 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 ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Serious side effects of acalabrutinib Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of treatment with acalabrutinib. Acalabrutinib may cause arrhythmias, which are problems with your heartbeat. Call your care team right away if you feel a change in the way your heart beats. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) 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. ACALABRUTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Handling body fluids and waste Acalabrutinib 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 acalabrutinib, 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 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 acalabrutinib 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 acalabrutinib. Women of childbearing age and potential should use effective contraception during therapy and for a minimum of four weeks after the last dose of acalabrutinib. Men of reproductive age and potential should use effective contraception during therapy and for a minimum of four weeks after the last dose of acalabrutinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking acalabrutinib and for two weeks after the last dose of acalabrutinib. 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. ACALABRUTINIB 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 © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved. Obtaining medication Talk with your care provider about the process for obtaining your acalabrutinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.calquence.com Product prescribing information: www.azpicentral.com/calquence/calquence.pdf#page=1 Product resources: www.calquence.com/patient/support for patients.html Updated – September 11, 2020 Additional instructions