Encorafenib

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. It is also used with cetuximab (Erbitux) to treat a certain type of colon cancer in adults that has spread to other parts of the body after other treatment(s). 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.

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.

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

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, 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.

• 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 breastfeeding. 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.

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

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.

• 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, or feeling faint

  • vision changes

  • 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

  • nose bleeding

  • redness, swelling, numbness and skin peeling of hands and soles of feet

• Encorafenib may cause an increased risk of developing cancer, 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

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.

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, 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.