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Generic Name: encorafenib
Dosage Form: Capsules
Date of Approval: June 27, 2018
Company: Array BioPharma Inc.

Treatment for: Melanoma

Medically reviewed on August 9, 2018

FDA Approves Braftovi

The U.S. Food and Drug Administration (FDA) has approved the kinase inhibitor Braftovi (encorafenib) in combination with Mektovi (binimetinib) for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Important information: If your healthcare provider prescribes Braftovi with binimetinib (Mektovi), please read the Patient Information leaflet that comes with binimetinib.

Important information

Braftovi may cause serious side effects, including:

  • Risk of new skin cancers. Braftovi when used alone, or with binimetinib, may cause skin cancers called cutaneous squamous cell carcinoma or basal cell carcinoma.
    Talk to your healthcare provider about your risk for these cancers.
    Check your skin and tell your healthcare provider right away about any skin changes, including a:
    • new wart
    • skin sore or reddish bump that bleeds or does not heal
    • change in size or color of a mole
    Your healthcare provider should check your skin before you start treatment, every two months during treatment, and for up to six months after you stop treatment with Braftovi to look for any new skin cancers.
    Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during your treatment.
    See Braftovi side effects for more information about side effects.

What is Braftovi?

Braftovi is a prescription medicine used in combination with a medicine called binimetinib to treat people with a type of skin cancer called melanoma:

  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal "BRAF" gene
Braftovi should not be used to treat people with wild-type BRAF melanoma. Your healthcare provider will perform a test to make sure this treatment is right for you.

It is not known if this medicine is safe and effective in children.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

  • have had bleeding problems
  • have eye problems
  • have heart problems, including a condition called long QT syndrome
  • have been told that you have low blood levels of potassium, calcium, or magnesium
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. Braftovi can harm your unborn baby.
    • Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during treatment, and for two weeks after your final dose. Birth control methods that contain hormones (such as birth control pills, injections or transdermal systems) may not work as well.
      • Talk to your healthcare provider about birth control methods that may be right for you during this time.
      • Your healthcare provider will do a pregnancy test before you start treatment. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.
  • are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk. Do not breastfeed during treatment, and for two weeks after your final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Braftovi and certain other medicines can affect each other, causing side effects or affecting how each of the other medicines work.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Braftovi?

  • Take Braftovi exactly as your healthcare provider tells you. Do not change your dose or stop treatment unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose, temporarily stop, or completely stop your treatment if you develop certain side effects.
  • Take Braftovi capsules in combination with binimetinib by mouth one time each day.
  • The capsules may be taken with or without food.
  • Avoid grapefruit during your treatment. Grapefruit products may increase the amount of Braftovi in your body.
  • If you miss a dose, take it as soon as you remember. If it is within 12 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.
  • Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
  • If you stop treatment with binimetinib, talk to your healthcare provider about your Braftovi treatment. Your Braftovi dose may need to be changed.

Braftovi side effects

Braftovi may cause serious side effects, including:

  • See Important information.
  • Bleeding problems. Braftovi, when taken with binimetinib, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like “coffee grounds”
    • red or black stools that look like tar
  • Eye problems. Tell your healthcare provider right away if you develop any of these symptoms of eye problems:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your healthcare provider should do tests before you start taking Braftovi with binimetinib and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or if you feel your heart beating irregularly or fast during treatment. These symptoms may be related to QT prolongation.

The most common side effects of Braftovi when taken with binimetinib, include:

  • fatigue
  • nausea
  • vomiting
  • abdominal pain
  • pain or swelling of your joints

Braftovi may cause fertility problems in males. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.

See also: Side effects (in more detail)

How should I store Braftovi?

  • Store Braftovi capsules at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store the capsules in the original bottle.
  • Keep the original bottle tightly closed and protect it from moisture. Braftovi comes with a desiccant packet in the bottle to help protect your medicine from moisture. Do not remove the desiccant packet from the bottle.

Keep all medicines out of the reach of children and pets.

General information about the safe and effective use of Braftovi.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use this medicine for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information that is written for health professionals.

What are the ingredients in Braftovi?

Active ingredient: encorafenib

Inactive ingredients: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, and magnesium stearate of vegetable origin

Capsule shell: gelatin, titanium dioxide, iron oxide red, iron oxide yellow, ferrosoferric oxide, monogramming ink (pharmaceutical glaze, ferrosoferric oxide, propylene glycol)

Further information

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