Encorafenib is used in combination 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 in combination 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.

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.

Although 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.

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

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

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

You may need to take 4 to 6 capsules at one time for a complete 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 dosing schedule without your doctor's advice.

Your doctor will need to check your skin every 2 months while you are using 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.

Usual Adult Dose for Melanoma -- Metastatic:

450 mg orally once a day in combination with binimetinib until disease progression or unacceptable toxicity
NOTE: If binimetinib is withheld, reduce encorafenib to a maximum dose of 300 mg once a day until binimetinib is resumed.

Comments:
-Confirm the presence of a BRAF V600E or V600K mutation in tumor specimens prior to initiating therapy.
-Refer to the binimetinib prescribing information for recommended dosing information.

Use: This drug, in combination with binimetinib, is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

Usual Adult Dose for Colorectal Cancer:

300 mg orally once a day in combination with cetuximab until disease progression or unacceptable toxicity

Comments:
-Confirm the presence of a BRAF V600E mutation in tumor specimens prior to initiating therapy.
-Refer to the cetuximab prescribing information for recommended dosing information.

Use: This drug, in combination with cetuximab, is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy

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 will 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.

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.

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.

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

Grapefruit may interact with encorafenib and lead to unwanted side effects. Avoid the use of grapefruit products.

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 at once 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 discontinued 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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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

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.