Brand Name(s):

Braftovi^®

WHY is this medicine prescribed?

Encorafenib is used along with binimetinib (Mektovi) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery. Encorafenib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

HOW should this medicine be used?

Encorafenib comes as a capsule to take by mouth. It is usually taken with or without food once daily. Take encorafenib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take encorafenib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking the medication, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease or temporarily or permanently stop your treatment depending on if you experience any side effects. Be sure to tell your doctor how you are feeling during your treatment with encorafenib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking encorafenib,

tell your doctor and pharmacist if you are allergic to encorafenib, any other medications, or any of the ingredients in encorafenib capsules. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products} you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone), carbamazepine (Carbatrol, Teril, others), citalopram (Celexa), clarithromycin (Biaxin, in Prevpac), diltiazem (Cardizem, Cartia, Diltzac, others), disopyramide (Norpace), erythromycin (E.E.S, PCE, others), efavirenz (Sustiva, in Atripla), indinavir (Crixivan), itraconazole (Onmel, Sporanox), ketoconazole, modafinil (Provigil), nefazodone, nelfinavir (Viracept), nevirapine (Viramune), phenobarbital, phenytoin (Dilantin, Phenytek), procainamide, quinidine (in Nuedexta), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), ritonavir (Norvir, in Kaletra), sotalol (Betapace, Sotylize), and verapamil (Calan, Verelan, in Tarka). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with encorafenib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
tell your doctor what herbal products you are taking, especially St John's wort.
tell your doctor if you have or have ever had a QT interval prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), low levels of potassium or magnesium in your blood, heart failure, or liver disease.
tell your doctor if you are pregnant or plan to become pregnant. You will have to take a pregnancy test before starting treatment. You should use a nonhormonal birth control to prevent pregnancy during your treatment with encorafenib and for 2 weeks after your final dose. Encorafenib may decrease the effectiveness of oral contraceptives (birth control pills), so it is especially important to use a nonhormonal form of birth control. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while taking encorafenib, call your doctor immediately. Encorafenib may harm the fetus.
tell your doctor if you are breast-feeding. Do not breastfeed while you are taking encorafenib and for 2 weeks after your final dose.
you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of taking encorafenib.

What SPECIAL DIETARY instructions should I follow?

Do not eat grapefruit or drink grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is within 12 hours of the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant (drying agent) from the bottle.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach.http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online athttps://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor, eye doctor, and the laboratory. Your doctor may order certain lab tests, including eye exams, to check your body's response to encorafenib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS^® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2018.