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