Encorafenib

Encorafenib is used along with a medicine called binimetinib (Mektovi) to treat melanoma (skin cancer) that cannot be treated with surgery or has spread to other parts of the body.

Encorafenib is used along with a medicine called cetuximab (Erbitux) to treat colorectal cancer that has spread to other parts of the body.

Encorafenib is used only if your cancer has a specific genetic marker (an abnormal "BRAF" gene). Your doctor will test you for this gene. Encorafenib is not for treating wild-type BRAF cancers.

Encorafenib may also be used for purposes not listed in this medication guide.

Your doctor will perform blood tests to confirm that you have the correct tumor type to be treated with encorafenib.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Encorafenib is usually taken once a day, with or without food.

You may need to take 4 to 6 capsules at one time for a full dose. Follow your doctor's dosing instructions very carefully.

If you vomit shortly after taking encorafenib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Do not change your dose or schedule without your doctor's advice.

Your doctor will need to check your skin every 2 months while you are taking encorafenib, and for up to 6 months after your last dose.

You will need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Encorafenib can harm an unborn baby. Do not use if you are pregnant. Use a non-hormonal form of birth control to prevent pregnancy while using encorafenib and for at least 2 weeks after your last dose.

Even though encorafenib is used to treat melanoma, using encorafenib may increase your risk of developing other types of skin cancer. Ask your doctor about your specific risk. Tell your doctor if you notice any new skin symptoms.

You should not use encorafenib if you are allergic to it.

Tell your doctor if you have ever had:

• heart problems;
• long QT syndrome (in you or a family member);
• lung disease;
• liver or kidney disease;
• eye problems (especially a problem with your retina); or
• bleeding problems, or a blood clot.

Although this medicine is used to treat melanoma, using encorafenib may increase your risk of developing other types of skin cancer. Tell your doctor if you notice any new skin symptoms such as redness, warts, sores that do not heal, or a mole that has changed in size or color.

You may need to have a negative pregnancy test before starting this treatment.

Do not use encorafenib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose. Tell your doctor if you become pregnant.

Encorafenib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using encorafenib, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

This medicine may affect fertility (ability to have children) in men.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects are more likely to occur if you take encorafenib and binimetinib together. Call your doctor right away if you have:

• eye pain or swelling, vision changes, seeing halos around lights, seeing color "dots" in your vision;
• severe skin rash, skin pain or swelling, redness and peeling skin on your hands or feet;
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out); or
• signs of bleeding--weakness, dizziness, headache, nosebleeds, rectal bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Your cancer treatments may be delayed or permanently stopped if you have certain side effects.

Common side effects of encorafenib may include:

• nausea, vomiting, stomach pain;
• tiredness; or
• joint pain or swelling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with encorafenib and cause unwanted side effects. Avoid using grapefruit products.

Sometimes, it is not safe to use certain medications together. Some drugs can change the amount of other drugs in your blood, which may increase side effects or make those medications less effective.

Other drugs may affect encorafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any new medicine you start or stop using.