Braftovi ) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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

Braftovi is used in combination with a medicine called cetuximab (Erbitux) to treat colorectal cancer that has been previously treated, and has spread to other parts of the body..

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

Although Braftovi 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 healthcare provider should check your skin before treatment with Braftovi, every 2 months during treatment, and for up to 6 months after you stop treatment to look for any new skin cancers.

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 Braftovi and for at least 2 weeks after your last dose.

Before taking this medicine

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

To make sure Braftovi is safe for you, 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.

Braftovi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Braftovi, 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 Braftovi exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

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

Braftovi 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 Braftovi, 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 Braftovi, 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 Braftovi if you are allergic to encorafenib.

To make sure Braftovi is safe for you, 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.

Braftovi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Braftovi, 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.

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 to Braftovi: 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 Braftovi side effects 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 interact with 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.