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Braftovi

Generic Name: encorafenib (EN koe RAF e nib)
Brand Names: Braftovi

Medically reviewed on Nov 12, 2018

What is Braftovi?

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

Braftovi is a prescription medicine used in combination with another medicine called binimetinib (Mektovi) to treat melanoma (skin cancer) in people who have a "BRAF" gene mutation.

These medicines are for use in treating melanoma that cannot be treated with surgery or has spread to other parts of the body.

Braftovi should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure that this medicine is right for you

Important Information

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 cause birth defects. Do not use if you are pregnant. Avoid getting pregnant 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:

  • heart disease, high blood pressure;

  • long QT syndrome (in you or a family member);

  • diabetes;

  • lung disease;

  • liver or kidney disease;

  • a muscle disorder;

  • eye problems (especially a problem with your retina); or

  • bleeding problems, or a blood clot.

Using Braftovi may increase your risk of developing a other types of skin cancer. Ask your doctor about your specific risk. 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.

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

You should not breast-feed while using this medicine, and for at least 3 days after your last dose.

How should I take Braftovi?

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 will perform blood tests to make sure you have the correct tumor type to be treated with this medicines.

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

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.

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

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Braftovi dosing information

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 orally 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.
-This drug may be taken with or without food.
-If a dose is missed, do not take it within 12 hours of the next dose.
-Do not take an additional dose if vomiting occurs after administration but continue with the next scheduled dose.

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

What happens if I miss a 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.

What happens if I overdose?

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

What should I avoid while taking Braftovi?

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

This medicine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Braftovi side effects

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 Braftovi and Mektovi 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, 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.

What other drugs will affect Braftovi?

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Braftovi only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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