Generic
Cobimetinib
(KOH-bih-MEH-tih-nib)
Brand
Cotellic®
(coh-TEL-lik)
Additional resources
Cobimetinib (Cotellic®) 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.
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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