Patient and Healthcare Provider Resource

Patient and Healthcare Providers Resource

OralChemoEdSheets.com, Patient + Healthcare Providers Resource

OralChemoEdSheets.com, the Patient and Healthcare Providers Resource

Copiktra™

(koo-PIK-truh)

Copiktra™ (Duvelisib) is used to treat adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Copiktra™ (Duvelisib) is used to treat adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Page 1 DUVELISIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Duvelisib DOO veh LIH sib Brand name — Copiktra™ koo PIK truh Approved uses Duvelisib is used to treat adults with certain types of leukemias and lymphomas, specifically chronic lymphocytic leukemia CLL , follicular B cell non Hodgkin lymphoma FL , and small lymphocytic lymphoma SLL . Dose and schedule Taking duvelisib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of duvelisib is 25 milligrams 25 mg to be taken by mouth at a scheduled time twice a day. Duvelisib can be taken with or without food, but at the same times each day. Duvelisib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow duvelisib, talk to your care provider or pharmacist for possible options. If you miss a dose of duvelisib: Only take the missed dose if it has been less than 6 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than 6 hours since you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle duvelisib with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store duvelisib at room temperature 68°F–77°F in a dry location away from light. Keep duvelisib out of reach of children and pets. Leave duvelisib in the provided packaging until it is ready to be taken. Whenever possible, you should give duvelisib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the duvelisib to you, they also need to follow these steps. 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. Gloves are not necessary if you give the drug to yourself. 3. Gently transfer the duvelisib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for duvelisib. Do not mix other medications into the box with duvelisib. The person filling the box or reminder should wear gloves. Gloves are not necessary if you are filling the box or reminder. When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused duvelisib, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of duvelisib. If you are traveling, put your duvelisib in a sealed plastic bag. Ask your pharmacist if additional travel precautions are needed. Handling body fluids and waste Since duvelisib remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take duvelisib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or duvelisib with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Drug and food interactions Duvelisib has many drug interactions, so inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Serious infections may develop, so monitor for signs and symptoms of infection. Severe diarrhea has occurred with the use of duvelisib, so monitor for development of worsening diarrhea. Serious skin reactions can develop, so report this side effect to your healthcare provider. Lung side effects have been reported with the use of duvelisib, so monitor for shortness of breath, chest pain, or worsening cough. DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Duvelisib The common side effects that have been known to happen in more than 30% of patients taking duvelisib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Diarrhea loose and/or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: The number of bowel movements you have in a day increases by 4 or more. You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide Imodium® to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, notice blood in your urine or stool, cough up blood, or have prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on next page DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 5 If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking duvelisib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 month after the last dose of duvelisib. Do not breastfeed while taking duvelisib and for 1 month after the last dose of duvelisib. Inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about the process for obtaining your duvelisib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Possible Side Effect Management Changes in electrolytes and other laboratory values High lipase levels High amylase levels High potassium levels Low phosphorus levels Low sodium levels Low albumin levels Changes in some laboratory values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs and feet Red or brown colored urine DUVELISIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www.copiktra.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2018/211155s000lbl.pdf Product resources: 1 833 570 2273 Updated – October 5, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Cotellic®

(coh-TEL-lik)

Cotellic® (Cobimetinib) is used to treat patients with melanoma with a genetic mutation called BRAF V600 E or V600K, and is used in combination with another medication, vemurafenib.

Cotellic® (Cobimetinib) is used to treat patients with melanoma with a genetic mutation called BRAF V600 E or V600K, and is used in combination with another medication, vemurafenib.

ShowAll Page1COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — cobimetinib (KOH-bih-MEH-tih-nib) Brand name — Cotellic® (coh-TEL-lik) Approved uses Cobimetinib is used to treat patients with melanoma with a genetic mutation called BRAF V600 E or V600K and is used in combination with another medication vemurafenib Dose and schedule Taking cobimetinib 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 cobimetinib is 60 milligrams (60 mg) to be taken by mouth on days 1–21 of each 28-day treatment cycle The dose may be adjusted by your care provider based on your individual needs o Cobimetinib can be taken with or without food but at the same time each day o Cobimetinib should be taken whole and not crushed cut or dissolved If you are unable to swallow cobimetinib talk to your care provider or pharmacist for possible options o If you miss a dose of cobimetinib 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 cobimetinib 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 cobimetinib at room temperature (68°F–77°F) in a dry location away from light o Keep cobimetinib out of reach of children and pets o Leave cobimetinib in the provided packaging until it is ready to be taken o Whenever possible give cobimetinib to yourself and follow the steps below If a family member friend or caregiver needs to give cobimetinib 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 cobimetinib 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 COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Page 2 o If a daily pill box or pill reminder is used a separate one should be used for cobimetinib Do not mix other medications into the box with cobimetinib 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 cobimetinib 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 cobimetinib o If you are traveling put your cobimetinib in a sealed plastic bag Ask your pharmacist if any additional travel precautions are needed Handling body fluids and waste Cobimetinib 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 cobimetinib 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 cobimetinib 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 Cobimetinib 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 Grapefruit and grapefruit juice may interact with cobimetinib Avoid eating and drinking these during treatment with cobimetinib o Talk with your care provider or pharmacist before taking new medications or supplements or receiving any vaccines COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Cobimetinib The common side effects that have been known to happen in more than 30% of patients taking cobimetinib 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 electrolyte and other laboratory values High creatine phosphokinase levels Low albumin levels Low phosphate levels Low sodium levels Changes in some lab values may occur and will be monitored by a simple blood test You may not feel any symptoms if the changes are mild and they usually are not a sign of a serious problem More severe changes may occur which can be a sign of a serious problem Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red- or brown-colored urine Decreased 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 Continued on the next page COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test Contact your care provider if you notice any of the following: Yellowing of the skin or whites of your eyes Dark or brown urine Unusual bleeding or bruising Decreased hemoglobin part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test When your hemoglobin is low you may notice that you get tired or fatigued more easily Try to get 7–8 hours of sleep per night Avoid operating heavy machinery if you feel too tired Find a balance between work and rest Stay as active as possible but know that it is okay to rest as needed You might notice that you are more pale than usual Let your care provider know right away if you experience: Shortness of breath Dizziness Palpitations 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 related to 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 such as raw vegetables raw fruits and whole grains Avoid foods that cause gas such as broccoli and beans Avoid lactose-containing foods such as yogurt and milk Avoid spicy fried and greasy foods Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by four or more You feel dizzy or lightheaded Your care provider may recommend an over-the-counter medication called loperamide (Imodium®) to help with your diarrhea but talk to your care provider before starting this medication Continued on the next page COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Sun sensitivity sunburn easily 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 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 lay 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 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 cobimetinib Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of two weeks after the last dose of cobimetinib o Do not breastfeed while taking cobimetinib for a minimum of two weeks after the last dose of cobimetinib 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 cobimetinib 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) COBIMETINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Additional resources Product website: www cotellic com Product prescribing information: www gene com/download/pdf/cotellic_prescribing pdf Product resources: www cotellic com/patient/support-resources/cotellic-melanoma-resources html 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

Crizotinib

(krih-ZOH-tih-nib)

Crizotinib (Xalkori®) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a mutation of the anaplastic lymphoma kinase (ALK) or ROS-1 genes.

Crizotinib (Xalkori®) is used to treat metastatic non-small cell lung cancer (NSCLC) that has a mutation of the anaplastic lymphoma kinase (ALK) or ROS-1 genes.

Page 1 CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name – crizotinib krih ZOH tih nib Brand Name – Xalkori® ZAL kor ee Approved uses Crizotinib is used to treat metastatic non small cell lung cancer NSCLC that has a mutation of the anaplastic lymphoma kinase ALK or ROS 1 genes. Dose and schedule Taking crizotinib 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 crizotinib is 250 milligrams 250 mg to be taken by mouth at a scheduled time two times a day. Crizotinib can be taken with or without food, but at the same times each day. Crizotinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow crizotinib, talk to your care provider or pharmacist for possible options. If you miss a dose of crizotinib: Only take the missed dose if it has been less than six hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. Do not take the missed dose if it has been more than six hours since you should have taken it. Simply take the next dose at the regularly scheduled time. Do not take two doses at one time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Storage and handling Handle crizotinib 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 crizotinib at room temperature 68°F–77°F in a dry location away from light. Keep crizotinib out of reach of children and pets. Leave crizotinib in the provided packaging until it is ready to be taken. Whenever possible, give crizotinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give crizotinib 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 crizotinib from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 2 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for crizotinib. Do not mix other medications into the box with crizotinib. 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 crizotinib, 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 crizotinib. If you are traveling, put your crizotinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since crizotinib 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 crizotinib, 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 crizotinib 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 Crizotinib 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 crizotinib; avoid eating or drinking these during treatment with crizotinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Crizotinib The common side effects that have been known to happen in more than 30% of patients taking crizotinib 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 any 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 bruising Eye changes This medication may cause blurred vision, dry eyes, or eye pain. Report changes in eyesight to your care provider. 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. Continued on the next page CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Diarrhea loose and/ or urgent bowel movements Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland, low fiber foods, such as bananas, applesauce, potatoes, chicken, rice, and toast. Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. Avoid foods that cause gas, such as broccoli and beans. Avoid lactose containing foods, such as yogurt and milk. Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: The number of bowel movements you have in a day increases by 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. 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. Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of 5 pounds or more in a week Continued on the next page CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Constipation Monitor how many bowel movements you have each day. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Stay active and exercise, if possible. Eat foods high in fiber like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in three or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener such as docusate Colace® and/or laxative such as senna Senakot® may be helpful. If these do not help within 48 hours, tell your provider. Changes in electrolytes and other laboratory values Low phosphorus 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 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 a cough, sneezing, runny nose, fever, and scratchy or sore throat to your provider. 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. Drink liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 crizotinib. Women of reproductive potential should use effective contraception during therapy and for a minimum of 45 days after the last dose of crizotinib. Men with female partners of reproductive protential should use effective contraception during therapy and for a mininum of three months after the last dose of crizotinib. Do not breastfeed while taking crizotinib and for 45 days after the last dose of crizotinib. 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 crizotinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: www.xalkori.com Product prescribing information: http://labeling.pfizer.com/showlabeling.aspx?id=676 Product resources: www.xalkori.com/resources Updated – November 6, 2017 CRIZOTINIB ORAL CHEMOTHERAPY EDUCATION Page 7 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2017 by Hematology/Oncology Pharmacy Association. All rights reserved.

Cyclophosphamide

(SY-kloh-FOS-fuh-mide)

Cyclophosphamide (Cytoxan®) is used to treat patients with the following:

  • Certain types of leukemias and lymphomas
  • Breast cancer
  • Multiple myeloma
  • Neuroblastoma
  • Ovarian cancer
  • Retinoblastoma

Cyclophosphamide (Cytoxan®) is used to treat patients with the following:

  • Certain types of leukemias...

Page 1 CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — cyclophosphamide SY kloh FOS fuh mide Brand name — Cytoxan® sy TOK sun Approved uses Cyclophosphamide is used to treat patients with the following: Certain types of leukemias and lymphomas Breast cancer Multiple myeloma Neuroblastoma Ovarian cancer Retinoblastoma Dose and schedule Taking cyclophosphamide as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Cyclophosphamide can be taken with or without food, but at the same time each day, preferably in the morning followed by drinking plenty of fluid throughout the day. Cyclophosphamide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow cyclophosphamide, talk to your care provider or pharmacist for possible options. If you miss a dose of cyclophosphamide, 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 cyclophosphamide 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 cyclophosphamide at room temperature 68°F–77°F in a dry location away from light. Keep cyclophosphamide out of reach of children and pets. Leave cyclophosphamide in the provided packaging until it is ready to be taken. Whenever possible, you should give cyclophosphamide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the cyclophosphamide 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 cyclophosphamide from its package to a small medicine or other disposable cup. CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for cyclophosphamide. Do not mix other medications into the box with cyclophosphamide. 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 cyclophosphamide, 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 cyclophosphamide. If you are traveling, put your cyclophosphamide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since cyclophosphamide 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 cyclophosphamide, 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 cyclophosphamide 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 Cyclophosphamide has many drug interactions. Inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Cyclophosphamide The common side effects that have been known to happen in more than 30% of patients taking cyclophosphamide are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page CYCLOPHOSPHAMIDE 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 Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Decreased 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. Drink liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking cyclophosphamide. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 4 months men to 12 months women after the last dose of cyclophosphamide. Do not breastfeed while taking cyclophosphamide and for one month after the last dose of cyclophosphamide. 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 cyclophosphamide. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/appletter/2012/012141s089ltr.pdf Updated – February 7, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Cytoxan®

(sy-TOK-sun))

Cytoxan® (Cyclophosphamide) is used to treat patients with the following:

  • Certain types of leukemias and lymphomas
  • Breast cancer
  • Multiple myeloma
  • Neuroblastoma
  • Ovarian cancer
  • Retinoblastoma

Cytoxan® (Cyclophosphamide) is used to treat patients with the following:

  • Certain types of leukemias and...

Page 1 CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — cyclophosphamide SY kloh FOS fuh mide Brand name — Cytoxan® sy TOK sun Approved uses Cyclophosphamide is used to treat patients with the following: Certain types of leukemias and lymphomas Breast cancer Multiple myeloma Neuroblastoma Ovarian cancer Retinoblastoma Dose and schedule Taking cyclophosphamide as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose is based on many factors, including your height and weight, overall health, and diagnosis. Cyclophosphamide can be taken with or without food, but at the same time each day, preferably in the morning followed by drinking plenty of fluid throughout the day. Cyclophosphamide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow cyclophosphamide, talk to your care provider or pharmacist for possible options. If you miss a dose of cyclophosphamide, 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 cyclophosphamide 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 cyclophosphamide at room temperature 68°F–77°F in a dry location away from light. Keep cyclophosphamide out of reach of children and pets. Leave cyclophosphamide in the provided packaging until it is ready to be taken. Whenever possible, you should give cyclophosphamide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the cyclophosphamide 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 cyclophosphamide from its package to a small medicine or other disposable cup. CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder is used, a separate one should be used for cyclophosphamide. Do not mix other medications into the box with cyclophosphamide. 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 cyclophosphamide, 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 cyclophosphamide. If you are traveling, put your cyclophosphamide in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since cyclophosphamide 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 cyclophosphamide, 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 cyclophosphamide 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 Cyclophosphamide has many drug interactions. Inform your care providers of all prescription medications, over thecounter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Cyclophosphamide The common side effects that have been known to happen in more than 30% of patients taking cyclophosphamide are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: A bloody nose that bleeds for more than five minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page CYCLOPHOSPHAMIDE 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 Nausea or vomiting Eat and drink slowly. Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. Eat small, frequent meals throughout the day rather than a few large meals. Eat bland foods; avoid spicy, fried, and greasy foods. Avoid vigorous exercise immediately after eating. Don’t lie down immediately after eating. Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Decreased 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. Drink liquid nutritional supplements. Drink 8–10 glasses of water or fluid each day, especially if you are not eating, unless your care provider has instructed you to limit your fluid intake. Hair loss alopecia Your hair will grow back after treatment is over. Some people choose to wear scarves, caps, or wigs. A short haircut prior to treatment may help with the stress of hair loss. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: INSTITUTIONAL CONTACT INFO CYCLOPHOSPHAMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking cyclophosphamide. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 4 months men to 12 months women after the last dose of cyclophosphamide. Do not breastfeed while taking cyclophosphamide and for one month after the last dose of cyclophosphamide. 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 cyclophosphamide. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/appletter/2012/012141s089ltr.pdf Updated – February 7, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Dabrafenib

(duh-BRA-feh-nib)

Dabrafenib (Tafinlar®) is used to treat patients with: • Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib. • Non-small cell lung cancer that has a genetic mutation called BRAF V600E and is used in combination with trametinib. •Anaplast...

Dabrafenib (Tafinlar®) is used to treat patients with: • Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib. • Non-small cell lung cancer that has a...

Page 1 DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — dabrafenib (duh BRA feh nib) Brand name — Tafinlar® (TA fin lar) Approved uses Dabrafenib is used to treat patients with the following: Melanoma that has a genetic mutation called BRAF V600E or V600K and may be used in combination with trametinib Non small cell lung cancer that has a genetic mutation called BRAF V600E and may be used in combination with trametinib Anaplastic thyroid cancer that has a genetic mutation called BRAF V600E and may be used in combination with trametinib Dose and schedule Taking dabrafenib 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 dabrafenib is 150 milligrams (mg) to be taken by mouth at a scheduled time twice a day. Dabrafenib should be taken twice daily and trametinib should be taken once daily at the same time every day. Both dabrafenib and trametinib should be taken on an empty stomach (one hour before or two hours after a meal or snack) and at the same time each day. Dabrafenib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dabrafenib, talk to your care provider or pharmacist for possible options. If you miss a dose of dabrafenib: • Take the missed dose only if it has been less than six hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. • Do not take 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 Dabrafenib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with dabrafenib. Avoid eating or drinking these during treatment with dabrafenib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 2 Storage and handling Handle dabrafenib 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 dabrafenib at room temperature (68°F–77°F) in a dry location away from light. Keep dabrafenib out of reach of children and pets. Leave dabrafenib in the provided packaging until it is ready to be taken. Whenever possible, give dabrafenib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give dabrafenib 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 dabrafenib 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 dabrafenib, 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 dabrafenib. If you are traveling, put your dabrafenib’s packaging in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed.DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Dabrafenib Below are common side effects that have been known to happen in about one third or more of patients taking dabrafenib 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 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. Thickening of the skin (hyperkeratosis) Ask your care provider for management strategies if this bothers you. 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. Continued on the next pageDABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Changes in electrolyte and other laboratory values • High glucose levels • Low phosphate levels • Low sodium levels Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine 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 Headache Ask your provider what you may use to ease headaches. Contact your care provider immediately if your headache: • 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, made worse by coughing or lowering the head, rash, weakness in an arm or leg, or numbness 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 (temperature more than 100.4°F or 38°C). • Ask your doctor if you can take medicine to help with the fever. Continued on the next pageDABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Muscle or joint pain or weakness • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is okay to rest as needed, too. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease this discomfort. Take pain medication only that has been prescribed or recommended by your care provider. 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. Serious side effects of dabrafenib Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of treatment with dabrafenib. You may be at a higher risk of bleeding while taking dabrafenib. Be sure to seek medical attention right away if you have any majore bleeding. Also be sure to check for any signs of bleeding in your stool. Dabrafenib 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. Dabrafenib may be harmful to your eyes. Be sure to inform your care provider of any issue you have with your vision, or pain in your eyes. Your provider may stop treatment with dabrafenib if your eyes are affected. Serious fevers can occur when dabrafenib is used with trametinib. If you have a G6PD deficiency, dabrafenib can increase risk for hemolytic anemia. Call your care team if you experience weakness, dizziness, yellowing of the skin or whites of your eyes, or dark or brown urine. Rarely, dabrafenib can cause severe skin reactions, including Stevens Johnson syndrome, which can be life threatening. Seek emergency care if you have a severe rash or a rash on your mouth, eyes, or genitals. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO)DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 6 Handling body fluids and waste Dabrafenib 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 dabrafenib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or dabrafenib 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 Men and women of childbearing age and potential should use effective nonhormonal contraception during therapy and for a minimum of two weeks after the last dose of dabrafenib. Dabrafenib can cause hormonal contraceptive to be ineffective. o Do not breastfeed while taking dabrafenib and for two weeks after the last dose of dabrafenib. 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 dabrafenib, and you are encouraged to ask your care provider. Obtaining medication Talk with your care provider about how to obtain your dabrafenib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO)DABRAFENIB ORAL CHEMOTHERAPY EDUCATION Page 7 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2021 by Hematology/Oncology Pharmacy Association. All rights reserved. Additional resources Product website: https://www.us.tafinlarmekinist.com Product prescribing information: https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/ files/tafinlar.pdf Product resources: Melanoma: https://www.us.tafinlarmekinist.com/advanced melanoma/patient support/patient resources Lung cancer: https://www.us.tafinlarmekinist.com/globalassets/products37.com/tafinlarmekinist/lung/tafinlarmekinist patient medication guide.pdf Updated — May 28, 2021 Additional instructions

Dabrafenib and Trametinib

(duh-BRA-feh-nib and truh-MEH-tih-nib)

The combination of dabrafenib and trametinib is used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Dabrafenib and Trametinib may also be used for other treatments.

The combination of dabrafenib and trametinib is used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Dabrafenib and Trametinib may also be used for other treatments.

Page 1 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic Names – dabrafenib (duh-BRA-feh-nib) and trametinib (truh-MEH-tih-nib) Brand Name – Tafinlar (TA-fin-lar) and Mekinist (MEH-kih-nist) Common uses The combination of dabrafenib and trametinib is used to treat a variety of cancers including melanoma, lung cancer, thyroid cancer or other cancers that have a certain mutation in a gene called BRAF. Dabrafenib and trametinib may also be used for other treatments. Dose and schedule Taking dabrafenib and trametinib as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. o For both dabrafenib and trametinib, 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. o Do not take an additional dose of either medication if vomiting occurs after administration. Continue with the next scheduled dose. o Both dabrafenib and trametinib should be taken on an empty stomach. Take dabrafenib and trametinib 1 hour before or at least 2 hours after a meal. o Dabrafenib and trametinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dabrafenib and trametinib, talk to your care provider or pharmacist for possible options. Drug and food interactions o Dabrafenib and trametinib have many drug interactions. Inform your care providers of all prescription medications, overthe counter medications, vitamins, and herbal products that you are taking. o Grapefruit or grapefruit juice may interact with dabrafenib; avoid eating or drinking these during treatment with dabrafenib. o Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Dabrafenib Trametinib Usual dose: 150 mg twice a day 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. Usual dose: 2 mg 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. Page 2 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Storage and handling Handle dabrafenib and trametinib 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 dabrafenib at room temperature (68 to 77 F) in a dry location away from light. o Store trametinib in the refrigerator (36 to 46 F) in a sealed plastic bag or closed container to prevent exposure to food and spills. Do not freeze. o Keep dabrafenib and trametinib out of reach of children and pets. o Leave dabrafenib and trametinib in the provided packaging until it is ready to be taken. o Whenever possible, you should give dabrafenib and trametinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the dabrafenib and trametinib 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 dabrafenib and trametinib 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 A daily pill box or pill reminder is not recommended to be used with dabrafenib or trametinib. o If you have any unused dabrafenib and trametinib, 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 dabrafenib and trametinib. o If you are traveling, put your dabrafenib and trametinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Page 3 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Side Effects of Dabrafenib and Trametinib The common side effects that have been known to happen in about one third or more of patients taking dabrafenib and trametinib 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 glucose levels • Low sodium levels • Low phosphate levels • Low albumin levels • Low calcium levels • Low magnesium levels Changes in some lab values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red- or brown-colored urine 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 (temperature more than 100.4°F or 38°C). • Ask your doctor if you can take medicine to help with the fever. 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 Continued on the next page Page 4 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION 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 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 known that it is okay to rest as needed, too. • You might notice that you are more pale than usual. Let your healthcare provider know right away if you experience: • Shortness of breath • Dizziness • Palpitations Nausea or vomiting • Eat and drink slowly. • Drink 8–10 glasses of water/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 lay down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page Page 5 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION Serious side effects of abiraterone acetate o Secondary malignancy is the growth of a cancer months or years after treatment. This is a rare but possible side effect of dabrafenib. o Dabrafenib and trametinib may be harmful to your eyes. Be sure to inform your care provider of any issue you have with your vision, or pain in your eyes. Your provider may stop treatment with dabrafenib if your eyes are affected. o Serious fevers can occur when dabrafenib is used with trametinib. Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water/fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low-fiber foods (such as bananas, applesauce, potatoes, chicken, rice, and toast). • Avoid high fiber foods, such as raw vegetables, raw fruits, and whole grains. • Avoid foods that cause gas, such as broccoli and beans. • Avoid lactose-containing foods, such as yogurt and milk. • Avoid spicy, fried, and greasy foods. Contact your provider if any of the following occur: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over-the-counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Rash or thickening of the skin (hyperkeratosis) • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over-the-counter antihistamine or a topical cream. • Sunlight can make symptoms worse. – Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV (ultraviolet) radiation occurs between the hours of 10 am and 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. Page 6 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION o If you have a G6PD deficiency, dabrafenib can increase risk for hemolytic anemia. Call your care team if you experience weakness, dizziness, yellowing of the skin or whites of your eyes, or dark or brown urine. o Trametinib may rarely cause irritation of your bowel or tear or hole in your intestine, called bowel perforation. Speak to your care team right away if you have diarrhea, high fever, nausea, vomiting, or severe stomach pain. o Trametinib may cause your lung tissue to scar, which is called interstitial lung disease, or swelling of lung tissue which is called pneumonitis. Call your care team if you are feeling short of breath, chest pain, have a fever, or have a lasting dry cough. o Dabrafenib and trametinib can cause serious birth defects. Do not take dabrafenib and trametinib if you are pregnant or think you might be pregnant. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: Handling body fluids and waste Since dabrafenib and trametinib 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 dabrafenib and trametinib, 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. 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 dabrafenib and trametinib 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 dabrafenib and trametinib. o Females of childbearing age and potential should use effective non-hormonal contraception during therapy and for a minimum of 2 weeks after the last dose of dabrafenib and effective contraception (may be hormonal) during therapy and for a minimum of 4 months after the last dose of trametinib. Page 7 DABRAFENIB AND TRAMETINIB ORAL CHEMOTHERAPY EDUCATION 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 © 2022 by Hematology/Oncology Pharmacy Association. All rights reserved. o Males with female partners of reproductive potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of dabrafenib and 4 months after trametinib. o Do not breastfeed while taking dabrafenib and trametinib and for 2 week after the last dose of dabrafenib and 4 months after the last dose of trametinib. o Please 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 team for assistance. Obtaining medication Talk with your care provider about the process for obtaining your dabrafenib and trametinib. Additional resources Product website: www.us.tafinlarmekinist.com Product prescribing information: www.novartis.com/us-en/sites/novartis_us/files/tafinlar.pdf, www.novartis.com/us-en/sites/novartis_us/files/mekinist.pdf Product website: www.us.tafinlarmekinist.com/advanced-melanoma, www.us.tafinlarmekinist.com/metastatic-nsclc Updated – December 19, 2022 Additional instructions

Dacomitinib

(DA-koh-MIH-tih-nib)

Dacomitinib (Vizimpro®) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor (EGFR).

Dacomitinib (Vizimpro®) is used to treat non-small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor (EGFR).

Page 1 DACOMITINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — Dacomitinib Brand name — Vizimpro® (vih ZIM pro) Approved uses Dacomitinib is used to treat non small cell lung cancer (NSCLC) that has a genetic mutation called epidermal growth factor (EGFR). Dose and schedule Taking dacomitinib 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 dacomitinib is 45 milligrams (45 mg) to be taken by mouth at a scheduled time once a day. Dacomitinib can be taken with or without food, but at the same time each day. Dacomitinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dacomitinib, talk to your care provider or pharmacist for possible options. If you miss a dose of dacomitinib, do not take an extra dose or two doses at one time. Simply take your next dose at the regularly scheduled time. Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Dacomitinib has many drug interactions, so inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. If you take an antacid or H2 blocker medicine during treatment, take your dose of dacomitinib at least 6 hours before or 10 hours after taking the antacid or H2 blocker medicine. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle dacomitinib 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 dacomitinib at room temperature (68°F–77°F) in a dry location away from light. Keep dacomitinib out of reach of children and pets. Leave dacomitinib in the provided packaging until it is ready to be taken. Whenever possible, you should give dacomitinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the dacomitinib 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 dacomitinib from its package to a small medicine or other disposable cup. DACOMITINIB ORAL CHEMOTHERAPY EDUCATION Page 2 Side Effects of Dacomitinib Below are common side effects that have been known to happen in about one third or more of patients taking dacomitinib 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 either of the following occurs: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Continued on the next page 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 dacomitinib, 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 dacomitinib. If you are traveling, put your dacomitinib’s packaging in a sealed plastic bag. Ask your pharmacist if additional travel precautions are needed. DACOMITINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Acne like rash A rash that looks like acne may develop on your face, chest, and upper back while taking this medication. • Your doctor may prescribe medication to help prevent or manage the rash. • If you do get a rash, keep the area around the rash clean and dry. • Check with your care provider before using anything to treat it. • Do not use over the counter acne treatments such as benzoyl peroxide or salicylic acid or soaps containing alcohol. • Oatmeal baths and unscented moisturizers may help with itching. • Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to UV (ultra violet) radiation occurs from the hours of 10 am through 4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on the bottle. • Use lip balm with at least SPF 30. Nail changes Usually this change starts at the cuticle and may affect the skin around the nail. • Biting, chewing, or picking at your nails can increase the risk of getting an infection. • Talk to your care provider if you notice any changes in your nails. 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 next page DACOMITINIB 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 Changes in electrolytes and other laboratory values • Low albumin levels • Low calcium levels • High glucose levels • Low lymphocyte count Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs and feet • Red or brown colored urine Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Decreased appetite or weight loss Talk to your care provider if you notice a decrease in weight while taking this medication. When you do not feel like eating, try the following: • Eat small frequent meals instead of 3 large meals each day. • Keep snacks nearby so you can eat when you feel hungry. • Try 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. DACOMITINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Serious side effects of dacomitinib Dacomitinib may cause your lung tissue to scar, which is called interstitial lung disease. Call your care team if you are feeling short of breath, have a fever, or have a lasting dry cough. If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since dacomitinib 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 dacomitinib, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or dacomitinib 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 Dacomitinib can cause serious birth defects. Women should not become pregnant and men should not get a partner pregnant while taking dacomitinib. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 17 days after the last dose of dacomitinib. Effective contraception could include one or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking dacomitinib and for 17 days after the last dose of dacomitinib. 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. DACOMITINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Obtaining medication Talk with your care provider about the process for obtaining your dacomitinib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: www.vizimpro.com Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2018/211288s000lbl.pdf Updated – August 3, 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.

Darolutamide

()

Darolutamide (Nubeqa®) is used to treat men with prostate cancer.

Darolutamide (Nubeqa®) is used to treat men with prostate cancer.

Page 1 DAROLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name Darolutamide Brand name Nubeqa® (NOO bə kə) Approved uses Darolutamide is used to treat men with prostate cancer. Dose and schedule Taking darolutamide 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 darolutamide is 600 milligrams (600 mg) to be taken by mouth at a scheduled time twice a day. Darolutamide should be taken with food, at the same times each day. Darolutamide should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow darolutamide, talk to your care provider or pharmacist for possible options. If you miss or vomit a dose of darolutamide, follow these guidelines: Take it as soon as you remember, unless your next scheduled dose is due within 6 hours. Take the next dose at your regular time. Do not take 2 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 Darolutamide 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 darolutamide; avoid eating or drinking this during treatment with darolutamide. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle darolutamide 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 darolutamide at room temperature (68°F–77°F) in a dry location away from light. Keep darolutamide out of reach of children and pets. Leave darolutamide in the provided packaging until it is ready to be taken. DAROLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 2 Whenever possible, you should give darolutamide to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the darolutamide 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 darolutamide 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 is not recommended to be used with darolutamide. If you have any unused darolutamide, 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 darolutamide. If you are traveling, put your darolutamide’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Darolutamide Below are common side effects that have been known to happen in about one third or more of patients taking darolutamide; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following. Yellowing of the skin or whites of your eyes Dark or brown urine Bleeding or bruising Continued on the next page DAROLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 3 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Serious side effects If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since darolutamide 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 darolutamide, it is important to adhere to the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or darolutamide with soap and water. DAROLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 4 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 darolutamide. Males and females of childbearing age and potential should use effective contraception during therapy and for a minimum of 1 week after the last dose of darolutamide. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. 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. Darolutamide can cause serious birth defects and loss of pregnancy. Do not take darolutamide if you are pregnant or think you might be pregnant. Obtaining medication Talk with your care provider about the process for obtaining your darolutamide. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.nubeqa us.com Product prescribing information: https://www.accessdata.fda.gov/drugsatfda docs/ label/2019/212099Orig1s000lbl.pdf Updated – November 9, 2019 Additional instructions DAROLUTAMIDE ORAL CHEMOTHERAPY EDUCATION Page 5 Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Dasatinib

(da-SA-tih-nib)

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

Dasatinib (Sprycel®) is used to treat adults and children with chronic myeloid leukemia (CML) that is Philadelphia chromosome–positive (Ph+). Dasatinib is also used to treat adults with acute lymphoblastic l...

Page 1 DASATINIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — dasatinib da SA tih nib Brand name — Sprycel® SPRY sel Approved uses Dasatinib is used to treat adults and children with chronic myeloid leukemia CML that is Philadelphia chromosome–positive Ph+ . Dasatinib is also used to treat adults with acute lymphoblastic leukemia ALL that is Ph+. Dose and schedule Taking dasatinib 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 dasatinib is 100 milligram 100 mg to 140 milligrams 140 mg to be taken by mouth at a scheduled time once a day. Dasatinib can be taken with or without food, but at the same time each day. Dasatinib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow dasatinib, talk to your care provider or pharmacist for possible options. If you miss a dose of dasatinib, 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 dasatinib 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 dasatinib at room temperature 68°F–77°F in a dry location away from light. Keep dasatinib out of reach of children and pets. Leave dasatinib in the provided packaging until it is ready to be taken. Whenever possible, you should give dasatinib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the dasatinib 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 dasatinib 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. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for dasatinib. Do not mix other medications into the box with dasatinib. 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 dasatinib, 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 dasatinib. If you are traveling, put your dasatinib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since dasatinib 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 dasatinib, it is important to follow the instructions below every day for as long as your treatment lasts. This will keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure all waste has been discarded. If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or dasatinib 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 Dasatinib has many drug interactions. Inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products that you are taking. Grapefruit or grapefruit juice may interact with dasatinib; avoid eating or drinking these during your treatment with dasatinib. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Dasatinib The common side effects that have been known to happen in more than 30% of patients taking dasatinib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. Use caution to avoid bruises, cuts, or burns. Blow your nose gently, and do not pick your nose. Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. When shaving, use an electronic razor instead of razor blades. Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include: A bloody nose that bleeds for more than 5 minutes despite pressure A cut that continues to ooze despite pressure Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or hold your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Continued on the next page DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 4 Possible Side Effect Management Decreased white blood cells WBCs and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection such as: Fever temperature more than 100.4°F or 38°C Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. 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 Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Avoid eating salty foods, which can increase swelling. Avoid wearing tight fitting clothing and shoes. Weigh yourself daily. Contact your care provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in a week Continued on the next page DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache: Follows a head injury Is severe or starts suddenly Does not go away after 3 days Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, rash, weakness in an arm or leg, or numbness; or is made worse by coughing or lowering the head. 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. 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 dasatinib. 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 dasatinib. Do not breastfeed while taking dasatinb and for two weeks after the last dose of dasatinib. 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 dasatinib, and you are encouraged to ask your care provider. DASATINIB ORAL CHEMOTHERAPY EDUCATION Page 6 Obtaining medication Talk with your care provider about the process for obtaining your dasatinib. PHARMACY OR SPECIALTY PHARMACY CONTACT INFO Additional resources Product website: https://www.sprycel.com Product prescribing information: https://packageinserts.bms.com/pi/pi sprycel.pdf Product resources: https://www.sprycel.com/resources Updated — March 6, 2018 Additional instructions Important notice: The Association of Community Cancer Centers ACCC , Hematology/Oncology Pharmacy Association HOPA , National Community Oncology Dispensing Association, Inc. NCODA , and Oncology Nursing Society ONS have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education OCE sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2018 by Hematology/Oncology Pharmacy Association. All rights reserved.

Daurismo®

(DOOR-is-moe)

Daurismo® (Glasdegib) is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents.

Daurismo® (Glasdegib) is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents.

Page 1 GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name glasdegib (glas DEH gib) Brand name Daurismo® (DOOR is moe) Approved uses Glasdegib is used to treat acute myeloid leukemia (AML) in combination with other chemotherapy agents. Dose and schedule Taking glasdegib 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 glasdegib is 100 milligrams (100 mg) to be taken by mouth at a scheduled time once a day. Glasdegib may be taken with or without food, but at the same time each day. Glasdegib should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow glasdegib, talk to your care provider or pharmacist for possible options. If you miss a dose of glasdegib, you may take the dose as soon as possible as long as it is at least 12 hours prior to the next scheduled dose. Do not take two doses within the same 12 hour time frame. Storage and handling Handle glasdegib 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 glasdegib at room temperature (68°F–77°F) in a dry location away from light. Keep glasdegib out of reach of children and pets. Leave glasdegib in the provided packaging until it is ready to be taken. Whenever possible, you should give glasdegib to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the glasdegib 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 glasdegib 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. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 2 If a daily pill box or pill reminder is used, a separate one should be used for glasdegib. Do not mix other medications into the box with glasdegib. 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 glasdegib, 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 glasdegib. If you are traveling, put your glasdegib in a sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Handling body fluids and waste Since glasdegib 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 glasdegib, 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 glasdegib 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 Glasdegib has many drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Serious side effects Glasdegib can cause serious birth defects. Do not take glasdegib if you are pregnant or think you might be pregnant. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 3 Side Effects of Glasdegib The common side effects that have been known to happen in more than 30% of patients taking glasdegib are listed in the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Changes in kidney function Your kidney (renal) function should be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: Decreased amount of urination Swelling in your legs and feet Changes in electrolytes and other laboratory values Low sodium levels Low magnesium levels Changes in some lab values may occur and will be monitored by a simple blood test. You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: Shortness of breath Chest discomfort Weakness or fatigue New aches and pains Headaches Dizziness Swelling of your legs or feet Red or brown colored urine Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored using a blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. Try to get 7–8 hours of sleep per night. Avoid operating heavy machinery if you feel too tired. Find a balance between work and rest. Stay as active as possible, but know that it is okay to rest as needed. You might notice that you are more pale than usual. Let your health care provider know right away if you experience any of the following: Shortness of breath Dizziness Palpitations Continued on the next page GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 4 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. Fatigue You may be more tired than usual or have less energy. Stay as active as possible, but know it is okay to rest as needed. Try to do some activity every day. Plan your activities, and do them at a time of day when you feel a bit more energetic. Avoid operating heavy machinery if you feel too tired. Continued on the next page GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 5 Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. Wash your hands often, especially before eating and after using the bathroom. Avoid crowds and people with fevers, flu, or other infection. Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: Fever (temperature more than 100.4°F or 38°C) Chills Sore throat Burning with urination Unusual tiredness A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Fluid retention or swelling Do not stand for long periods of time. Keep your legs elevated when sitting or lying down. Try not to eat salty foods, which can increase swelling. Avoid tight fitting clothing and shoes. Weigh yourself daily. Contact your provider if you notice any of the following: Swelling in the hands, feet, or legs Shortness of breath Weight gain of five pounds or more in one week Muscle or joint pain Keep a diary of your pain (or spasms), including a description of when and where the pain is occurring, what it feels like, and how long it lasts. Stay as active as possible, but know it is okay to rest as needed. Tell your care provider if pain (or spasms) 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. Warnings and precautions Do not donate blood or blood products during treatment with glasdegib and for at least 30 days after the last dose. Changes in the electrical activity of your heart are 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 glasdegib. GLASDEGIB ORAL CHEMOTHERAPY EDUCATION Page 6 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 glasdegib. 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 glasdegib. Do not breastfeed while taking glasdegib and for 30 days after the last dose of glasdegib. 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 glasdegib. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product prescribing information: www.accessdata.fda.gov/drugsatfda docs/label/2018/210656s000lbl.pdf Updated – November 26, 2018 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2019 by Hematology/Oncology Pharmacy Association. All rights reserved.

Decitabine and Cedazuridine

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

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

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

Page 1 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Name of your medication Generic name — decitabine and cedazuridine (deh SIH tuh been and SEE daz YOOR ih deen) Brand name — Inqovi® (in KOH vee) Approved uses Decitabine and cedazuridine is a combination product used to treat myelodysplastic syndromes (MDS). Dose and schedule Taking decitabine and cedazuridine as instructed is important to allow your treatment to be as effective as possible, so here are some key points to remember. Your dose may vary, but the usual dose of decitabine and cedazuridine is 1 tablet (35 milligrams decitabine and 100 milligrams cedazuridine) to be taken by mouth at a scheduled time once daily on days 1 to 5 of each 28 day treatment cycle. Decitabine and cedazuridine should be taken on an empty stomach, at the same time each day. Do not eat food 2 hours before or 2 hours after each dose. Decitabine and cedazuridine should be taken whole and not crushed, cut, or dissolved. If you are unable to swallow decitabine and cedazuridine, talk to your care provider or pharmacist for possible options. If you miss a dose of decitabine and cedazuridine, follow these guidelines: • Only take the missed dose if it has been less than 12 hours since you were supposed to take it. Then take the next dose at the regularly scheduled time. • Do not take 2 doses at one time. • If vomiting occurs after a dose, do not take an additional dose but continue with the next scheduled dose. • Be sure to write down if you miss a dose and let your care provider know about any missed doses. Drug and food interactions Decitabine and cedazuridine may have drug interactions. Please inform your care providers of all prescription medications, over the counter medications, vitamins, and herbal products. Talk with your care provider or pharmacist before taking new medications or supplements, or receiving any vaccines. Storage and handling Handle decitabine and cedazuridine with care. Just like when chemotherapy is given into the vein, this drug can be toxic, and exposure of the drug to others should be limited. Store decitabine and cedazuridine at room temperature (68°F–77°F) in a dry location away from light. Keep decitabine and cedazuridine out of reach of children and pets. Leave decitabine and cedazuridine in the provided packaging until it is ready to be taken. Whenever possible, you should give decitabine and cedazuridine to yourself and follow the steps below. If a family member, friend, or caregiver needs to give the decitabine and cedazuridine to you, they also need to follow these steps. Page 2 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION 1. Wash hands with soap and water. 2. Put on gloves to avoid touching the medication. (Gloves are not necessary if you give the drug to yourself.) 3. Gently transfer the decitabine and cedazuridine from its package to a small medicine or other disposable cup. 4. Administer the medicine immediately by mouth with water. 5. Remove gloves and do not use them for anything else. 6. Throw gloves and medicine cup in household trash. 7. Wash hands with soap and water. If a daily pill box or pill reminder will be used, contact your care team before using. • The person filling the box or reminder should wear gloves (gloves are not necessary if you are filling the box or reminder). • When empty, the box or reminder should be washed with soap and water before refilling. Be sure to wash hands with soap and water after the task is complete, whether or not gloves are worn. If you have any unused decitabine and cedazuridine, do not throw it in the trash and do not flush it down the sink or toilet. Talk to your care provider or pharmacist about proper disposal of decitabine and cedazuridine. If you are traveling, put your decitabine and cedazuridine’s packaging in a separate sealed plastic bag. Ask your pharmacist if any additional travel precautions are needed. Side Effects of Decitabine and Cedazuridine Below are common side effects that have been known to happen in about one third or more of patients taking decitabine and cedazuridine; these are listed on the left side of this table. You MAY NOT experience these side effects. Options to help manage any side effects that do occur are included on the right side of this table. These should be discussed with your care provider. If you experience any side effect you cannot manage or that is not listed here, contact your care provider. Possible Side Effect Management Decreased white blood cells (WBCs) and increased risk for infection Your WBCs should be monitored by a simple blood test. When your WBCs are low, you are at a greater risk of having an infection. Take the following precautions to protect yourself from infection. • Wash your hands often, especially before eating and after using the bathroom. • Avoid crowds and people with fevers, flu, or other infection. • Bathe regularly to keep good personal hygiene. Contact your care provider if you experience any signs or symptoms of an infection: • Fever (temperature more than 100.4°F or 38°C) • Chills • Sore throat • Burning with urination • Unusual tiredness • A sore that becomes red, is draining, or does not heal Check with your care provider before taking any medicine for a fever or chills. Continued on the next page Page 3 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Decreased platelet count and increased risk of bleeding Your platelets should be monitored by a simple blood test. When they are low, you may bruise or bleed more easily than usual. • Use caution to avoid bruises, cuts, or burns. • Blow your nose gently, and do not pick your nose. • Brush your teeth gently with a soft toothbrush, and maintain good oral hygiene. • When shaving, use an electronic razor instead of razor blades. • Use a nail file instead of nail clippers. Call your care provider if you have bleeding that won’t stop. Examples include the following: • A bloody nose that bleeds for more than five minutes despite pressure • A cut that continues to ooze despite pressure • Gums that bleed excessively when you floss or brush Seek medical help immediately if you experience any severe headaches, observe blood in your urine or stool, cough up blood, or experience prolonged and uncontrollable bleeding. You may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Decreased hemoglobin, part of the red blood cells that carry iron and oxygen Your hemoglobin should be monitored by a simple blood test. When your hemoglobin is low, you may notice that you get tired or fatigued more easily. • Try to get 7–8 hours of sleep per night. • Avoid operating heavy machinery if you feel too tired. • Find a balance between work and rest. • Stay as active as possible, but know that it is OK to rest as needed. • You might notice that you are more pale than usual. Let your care provider know right away if you experience any of the following: • Shortness of breath • Dizziness • Palpitations Fatigue You may be more tired than usual or have less energy. • Stay as active as possible, but know it is OK to rest as needed. • Try to do some activity every day. • Plan your activities, and do them at a time of day when you feel a bit more energetic. • Avoid operating cars or machinery if you feel too tired. Continued on the next page Page 4 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Constipation Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Stay active and exercise, if possible. • Eat foods high in fiber, like raw fruits and vegetables. Contact your care provider if you have not had a bowel movement in 3 or more days. Your care provider may recommend over the counter medications to help with your constipation. A daily stool softener, such as docusate (Colace®), and/or a laxative, such as senna (Senokot®), may be helpful. If these do not help within 48 hours, tell your provider. Muscle or joint pain or weakness • Keep a diary of your pain, including a description of when and where the pain is occurring, what it feels like, and how long it lasts. • Stay as active as possible, but know that it is OK to rest as needed, too. • Tell your care provider if pain interferes with your activity. If the pain or weakness bothers you, ask your provider how you may ease this discomfort. Take only pain medication that has been prescribed or recommended by your care provider Mouth irritation or sores Practice good mouth care. • Rinse your mouth frequently. • Brush your teeth with a soft toothbrush or cotton swab after meals. • Use a mild nonalcohol mouth rinse at least 4 times a day (after eating and at bedtime). For example, you can use a mixture of 1/8 teaspoon of salt and 1/4 teaspoon of baking soda in 8 ounces of warm (not hot) water. • If you have sores in your mouth, avoid using tobacco products, alcohol, and mouthwashes that contain alcohol. Call your care provider if you experience pain or sores in your mouth or throat. Nausea or vomiting • Eat and drink slowly. • Drink 8 10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland foods; avoid spicy, fried, and greasy foods. • Avoid vigorous exercise immediately after eating. • Don’t lie down immediately after eating. • Avoid strong odors. Let your provider know if you experience nausea or vomiting. Your provider may prescribe medication to help with the nausea or vomiting. Continued on the next page Page 5 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Possible Side Effect Management Diarrhea (loose and/ or urgent bowel movements) Monitor how many bowel movements you have each day. • Drink 8–10 glasses of water or fluid each day unless your care provider has instructed you to limit your fluid intake because of some other health problem. • Eat small, frequent meals throughout the day rather than a few large meals. • Eat bland, low fiber foods (e.g., bananas, applesauce, potatoes, chicken, rice, toast). • Avoid high fiber foods (e.g., raw vegetables, raw fruits, whole grains). • Avoid foods that cause gas (e.g., broccoli, beans). • Avoid lactose containing foods (e.g., yogurt, milk). • Avoid spicy, fried, and greasy foods. Contact your provider if either of the following occurs: • The number of bowel movements you have in a day increases by 4 or more. • You feel dizzy or lightheaded. Your care provider may recommend an over the counter medication called loperamide (Imodium®) to help with your diarrhea, but talk to your care provider before starting this medication. Rash or itchy skin • Keep your skin moisturized with creams and moisturizing lotions to decrease the risk of rash or itchiness, and wear loose fitting clothing. • Avoid using perfumes and cologne as these products may increase rash symptoms. • Avoid being in the heat for long periods of time. • Your provider may recommend an over the counter antihistamine or a topical cream. Sunlight can make symptoms worse. • Avoid sun exposure as much as possible to decrease the risk of sunburn. The highest exposure to ultraviolet (UV) radiation occurs from 10 am to 4 pm. • Wear long sleeved clothing, with UV protection if possible. • Wear broad brimmed hats. • Apply broad spectrum sunscreen (UVA/UVB) with at least SPF 30 as often as directed on the bottle. • Use lip balm with at least SPF 30. If your rash or itching continues to worsen, contact your care provider. Fluid retention or swelling • Do not stand for long periods of time. • Keep your legs elevated when sitting or lying down. • Avoid eating salty foods, which can increase swelling. • Avoid wearing tight fitting clothing and shoes. • Weigh yourself daily. Contact your care provider if you notice any of the following: • Swelling in the hands, feet, or legs • Shortness of breath • Weight gain of 5 or more pounds in 1 week Continued on the next page Page 6 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Serious side effects Decitabine and cedazuridine can cause serious birth defects. Do not take decitabine and cedazuridine if you are pregnant or think you might be pregnant. Decitabine and cedazuridine can lower your white blood cells and your platelets, increasing your risk of infection and bleeding. Bone marrow suppression is a decrease in the number of white blood cells, red blood cells, and platelets that can be severe with decitabine and cedazuridine. Speak to your care provider to know when you need to have laboratory tests done to monitor your blood cell counts. You also may need to take a break or “hold” your medication for medical or dental procedures. Talk to your care provider or dentist before any scheduled procedures. Possible Side Effect Management Headache Ask your provider what you may use to help with this discomfort. Contact your care provider right away if your headache has any of the following characteristics: • Follows a head injury • Is severe or starts suddenly • Does not go away after 3 days • Is associated with vomiting, visual disturbance, neck stiffness, drowsiness, confusion, rash, weakness in an arm or leg, or numbness • Is made worse by coughing or lowering the head Changes in liver function Your liver function will be checked periodically by a simple blood test. Contact your care provider if you notice any of the following: • Yellowing of the skin or whites of your eyes • Dark or brown urine • Bleeding or bruising Changes in electrolytes and other laboratory values • High or low glucose levels • Low albumin levels • Low sodium levels • Low calcium levels Changes in some laboratory values may occur and will be monitored by a simple blood test. • You may not feel any symptoms if the changes are mild, and they usually are not a sign of a serious problem. • More severe changes may occur, which can be a sign of a serious problem. Notify your care provider if you have any of the following: • Shortness of breath • Chest discomfort • Weakness or fatigue • New aches and pains • Headaches • Dizziness • Swelling of your legs or feet • Red or brown colored urine Page 7 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION If you experience ANY uncontrolled side effect, call your physician or healthcare center immediately: (INSTITUTIONAL CONTACT INFO) Handling body fluids and waste Since decitabine and cedazuridine remains in your body for several days after it is taken, some of the drug may be present in urine, stool, sweat, or vomit. Once you have started to take decitabine and cedazuridine it is important to know the following instructions every day for as long as your treatment lasts. This is to keep yourself, loved ones, and the environment as safe as possible. Pregnant women should avoid touching anything that may be soiled with body fluids from the patient. Toilet and septic systems • You may use the same toilet, septic tank, and/or sewer that you usually use. If you have a low flow toilet, close the lid and flush twice to ensure that all waste has been discarded. • If the toilet or toilet seat becomes soiled with urine, stool, or vomit, clean the surfaces before other people use the toilet. • Wash hands with soap and water after using the toilet. If you need a bedpan, be sure your caregiver knows to wear gloves to assist with cleanup and to wash the bedpan with soap and water every day. If you do not have good control of bladder or bowels, use a disposable pad with a plastic back, a diaper, or a sheet to absorb body waste. Wash any skin that has been exposed to body waste or decitabine and cedazuridine with soap and water. Linens or clothing that are soiled with body fluids or body waste should be washed separately from other linens and clothing. If you do not have a washer, place the soiled linens in a plastic bag until they can be washed. Wash hands with soap and water after touching linens or clothing that may be soiled with body fluids. Pregnancy, sexual activity, and contraception Women should not become pregnant and men should not get a partner pregnant while taking decitabine and cedazuridine. Men and women of childbearing age and potential should use effective contraception during therapy and for a minimum of 6 months (women) and 3 months (men) after the last dose of decitabine and cedazuridine. Effective contraception could include 1 or more of the following: oral contraceptive, barrier methods, etc. Do not breastfeed while taking decitabine and cedazuridine and for 2 weeks after the last dose of decitabine and cedazuridine. Please inform your care provider if you become pregnant. It is safe to hug and kiss. Special precautions may be needed for sexual activity while on oral chemotherapy, and you are encouraged to ask your care team for assistance. Page 8 DECITABINE AND CEDAZURIDINE ORAL CHEMOTHERAPY EDUCATION Obtaining medication Talk with your care provider about the process for obtaining your decitabine and cedazuridine. (PHARMACY OR SPECIALTY PHARMACY CONTACT INFO) Additional resources Product website: https://www.inqovi.com Product prescribing information: https://www.inqovi.com Financial assistance: www.taihopatientsupport.com Updated – October 2, 2020 Additional instructions Important notice: The Association of Community Cancer Centers (ACCC), Hematology/Oncology Pharmacy Association (HOPA), National Community Oncology Dispensing Association, Inc. (NCODA), and Oncology Nursing Society (ONS) have collaborated in gathering information for and developing this patient education guide. This guide represents a brief summary of the medication derived from information provided by the drug manufacturer and other resources. This guide does not cover all existing information related to the possible uses, directions, doses, precautions, warnings, interactions, adverse effects, or risks associated with this medication and should not substitute for the advice of a qualified healthcare professional. Provision of this guide is for informational purposes only and does not constitute or imply endorsement, recommendation, or favoring of this medication by ACCC, HOPA, NCODA, or ONS, who assume no liability for and cannot ensure the accuracy of the information presented. The collaborators are not making any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional. Permission: Oral Chemotherapy Education (OCE) sheets are provided as a free educational resource for patients with cancer in need of concise, easy to understand information about oral cancer drugs. Healthcare providers are permitted to copy and distribute the sheets to patients as well as direct patients to the OCE website for information. However, commercial reproduction or reuse, as well as rebranding or reposting of any type, are strictly prohibited without permission of the copyright holder. Please email permission requests and licensing inquiries to This email address is being protected from spambots. You need JavaScript enabled to view it.. Copyright © 2020 by Hematology/Oncology Pharmacy Association. All rights reserved.

Our Sponsors