Encorafenib

WHY is this medicine prescribed?

Encorafenib is used to treat:

• • melanoma (a type of skin cancer)
  • a certain type of colon cancer (cancer that develops in the large intestine)
  • certain types of non small cell lung cancer (NSCLC; a type of cancer of the lungs)

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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Encorafenib comes as a capsule to take by mouth. Take with or without food once daily. Take around the same time every day.

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 need to adjust your dose or delay or stop your treatment depending on side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.

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

What SPECIAL PRECAUTIONS should I follow?

Before taking encorafenib,

• Tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, food, or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following herbal product may interact with encorafenib: St John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking encorafenib. Do not start this medication while taking encorafenib without discussing with your healthcare provider.

• You should know that encorafenib may decrease the effectiveness of hormonal contraceptives(birth control pills, patches, rings, and injections). You will need to use another method ofcontraception to prevent pregnancy while taking encorafenib. Talk to your doctor about otherways to prevent pregnancy while you are taking this medication.

• 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), heart failure, a heart attack or any other heart problems; low levels of potassium, calcium, or magnesium in your blood; bleeding problems; eye problems; or liver or kidney disease.

• Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking encorafenib. If you can become pregnant you may have to take a pregnancy test before starting treatment. You should use a nonhormonal birth control to prevent pregnancy during your treatment and for 2 weeks after your final dose. 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 breastfeeding or plan to breastfeed. 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?

Encorafenib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fatigue
• fever
• nausea
• vomiting
• stomach pain
• constipation
• decreased appetite
• headache
• dizziness
• skin thickening
• rash
• dry or itchy skin
• hair loss
• joint or muscle pain
• change in taste
• back, arm, or leg pain
• acne
• numbness, burning, or tingling in the arms, hands, feet, or legs
• difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• dizziness, fainting, feeling faint, or fast or irregular heartbeat
• blurred vision, loss of vision, or other vision changes; or eye pain, swelling, or redness
• skin changes such as new wart, a sore or reddish bump that does not heal, a change in the size or color of a mole
• unusual bleeding or bruising; black, tarry, or bloody stools; coughing up blood; vomiting blood or material that looks like coffee grounds; or nose bleeds
• swelling in your hands, ankles legs or feet; shortness of breath; fast or pounding heartbeat; or feeling lightheaded or faint
• nausea, vomiting, lack of energy, loss of appetite, dark colored urine, pain in the upperright part of the stomach, or yellowing of the skin or eyes
• redness, swelling, numbness and skin peeling of hands and soles of feet

Encorafenib may increase the risk that you will develop other cancers, including skin cancer. Your doctor will check your skin before treatment, every 2 months during treatment, and for up to 6 months after your final dose of encorafenib for signs of skin cancer. Talk to your doctor about the risks of taking this medication.

Encorafenib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 at https://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 will order a lab test before you begin your treatment to see whether your cancer can be treated with encorafenib. Your doctor may order certain lab tests, including eye exams and echocardiograms (test that uses sound waves to measure your heart's ability to pump blood), 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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.