Encorafenib (en-koe-KAF-a-nib)

Treats melanoma (skin cancer), colorectal (colon and rectum) cancer, and non-small cell lung cancer (NSCLC).

Brand Name(s):

Braftovi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, take it as soon as you remember. If it is 12 hours or less until your next scheduled dose, skip the missed dose and go back to your regular dosing schedule. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose, do not take an extra dose. Take your next dose at your regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original container.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how encorafenib works. Tell your doctor if you are using diltiazem, posaconazole, rosuvastatin, birth control pills, or medicine for heart rhythm problems.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Birth control pills may not work as well to prevent pregnancy when used together with this medicine. Use another form of birth control such as condoms or spermicide. Use an effective form of birth control during treatment and for at least 2 weeks after the last dose.
• Do not breastfeed during treatment and for 2 weeks after the last dose.
• Tell your doctor if you have kidney disease, liver disease, eye problems, bleeding problems, or heart rhythm problems.
• This medicine may cause the following problems:
  • Increased risk for other cancers (skin and non-skin cancer)
  • Increased risk of bleeding
  • Heart problems (including cardiomyopathy)
  • Liver problems
  • Eye or vision problems, including uveitis, iritis, and iridocyclitis
  • Heart rhythm problems, including QT prolongation
• Some men who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bleeding gums, coughing up blood, unusual nosebleeds, red or dark-brown urine, or red or black, tarry stools
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Eye pain, vision changes, sensitivity to light
• Fast, slow, or pounding heartbeat
• Numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Unusual bleeding, bruising, or weakness
• Warts, skin sores, or reddish bumps that do not heal

If you notice these less serious side effects, talk with your doctor:

• Acne or pimples
• Constipation, diarrhea, nausea, vomiting, stomach pain, loss of appetite
• Joint or muscle pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088