Pronunciation: braf-TOE-vee
Generic name: encorafenib
Dosage form: oral capsule
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 30, 2024.

What is Braftovi?

Braftovi is a targeted cancer treatment used in combination with: 

• Mektovi to treat melanoma that has spread or cannot be removed by surgery, and has a certain type of abnormal "BRAF" gene

• Erbitux and mFOLFOX6 (fluorouracil, leucovorin and oxaliplatin) to treat colorectal cancer that has spread and has a certain type of abnormal “BRAF” gene

• Erbitux to treat colorectal cancer that has spread despite past treatment and has a certain type of abnormal “BRAF” gene

• Mektovi to treat non-small cell lung cancer (NSCLC) that has spread and has a certain type of abnormal “BRAF” gene.

Braftovi should not be used to treat people with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a genetic test to make sure that Braftovi is right for you.

Braftovi's mechanism of action involves binding to and blocking the action of a protein called BRAF, which plays a crucial role in regulating cell growth and division. When BRAF becomes mutated, particularly with the V600E mutation, it becomes overactive and causes cells to grow and divide uncontrollably, leading to cancer. By blocking BRAF, Braftovi interrupts the signaling pathway that drives cancer cell growth and survival, which stops or slows down cancer growth. Braftovi is often prescribed in combination with other targeted therapies, particularly MEK inhibitors like Mektovi (binimetinib), which helps prevent the development of drug resistance that can occur when BRAF inhibitors are used alone.

Braftovi (generic name encorafenib) is not chemotherapy it is a targeted treatment that belongs to the drug class called kinase inhibitors.

Braftovi first gained FDA approval on June 27, 2018 for metastatic or unresectable melanoma with BRAF mutations. Approval of Braftovi with Erbitux and mFOLFOX6 for colorectal cancer is under the accelerated approval designation and is contingent upon a continued benefit being shown in future clinical trials.

It is not known if Braftovi is safe and effective in children

Braftovi side effects

The most common side effects of Braftovi when taken in combination with Mektovi for melanoma are:

• fatigue
• nausea
• vomiting
• abdominal pain
• pain or swelling of your joints (arthralgia).

The most common side effects of Braftovi when taken in combination with Erbitux and mFOLFOX6 for colorectal cancer are:

• numbness, tingling or burning in your hands or feet (peripheral neuropathy) 
• decreased appetite
• vomiting
• nausea
• bleeding (hemorrhage)
• fatigue
• stomach-area (abdominal) pain
• rash
• fever
• diarrhea.

The most common side effects of Braftovi when taken in combination with Erbitux for colorectal cancer are:

• fatigue
• stomach-area (abdominal) pain
• nausea
• decreased appetite
• diarrhea
• pain or swelling of your joints (arthralgia)
• acne-like rash (dermatitis acneiform)
• rash.

The most common side effects of Braftovi when taken in combination with Mektovi for NSCLC are:

• fatigue
• blurred vision, loss of vision, or other vision changes
• nausea
• constipation
• diarrhea
• shortness of breath
• muscle or joint pain
• rash
• vomiting
• cough
• stomach-area (abdominal) pain.

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

Serious side effects and warnings

Braftovi may cause serious the following side effects.

Risk of new skin cancers. Braftovi when used alone, or with Mektovi or Erbitux, 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 treatment with Braftovi, every 2 months during treatment, and for up to 6 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 treatment with Braftovi.

Heart problems, including heart failure. Braftovi, when taken with Mektovi, can cause heart problems. Your healthcare provider will check your heart function before and during treatment with Braftovi. Tell your healthcare provider right away if you get any of the following signs and symptoms of a heart problem:

• feeling like your heart is pounding or racing
• shortness of breath
• swelling in your hands, ankles legs or feet
• feeling faint or lightheaded.

Liver problems. Braftovi, when taken with Mektovi, can cause liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment with Braftovi. Tell your healthcare provider if you get any of the following signs and symptoms of a liver problem:

• yellowing of your skin or your eyes
• tiredness
• dark or brown (tea-colored) urine
• bruising
• nausea or vomiting
• bleeding
• loss of appetite.

Bleeding problems. Braftovi, when taken with Mektovi or Erbitux, can cause serious bleeding problems, including in your stomach or brain, that can lead to death. Tell your healthcare provider and get medical help right away if you develop any signs of bleeding, including:

• headaches, dizziness, or feeling weak
• coughing up blood or blood clots
• vomit blood or your vomit looks like “coffee grounds”
• red or black stools that look like tar
• nose bleeds.

Eye problems. Braftovi, when taken with Mektovi, can cause eye problems. Your healthcare provider should perform an eye exam regularly. Tell your healthcare provider right away if you develop any new or worsening symptoms of eye problems, including:

• 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 Mektovi or Erbitux and during your treatment, 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 with Braftovi and Mektovi or Erbitux. These symptoms may be related to QT prolongation.

Braftovi can harm an unborn baby.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Braftovi if you have certain side effects.

These are not all of the possible side effects of Braftovi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Pfizer Inc. at 1-800-438-1985. 

Related/similar drugs

Before taking this medicine

You should not use Braftovi if you are allergic to encorafenib, Braftovi, or any of the other ingredients in the capsules.

To make sure Braftovi is safe for you, tell your healthcare provider if you have ever had:

• heart problems including a condition called 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
• have had bleeding problems
• have been told that you have low blood levels of potassium, calcium, or magnesium
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

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

Pregnancy

Do not use Braftovi if you are pregnant. Your healthcare provider may conduct a pregnancy test before you start treatment if you are a woman of childbearing age. 

Braftovi can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. Females who can become pregnant should use effective non-hormonal birth control (contraception) during treatment with Braftovi and for 2 weeks after the last dose, such as a condom, diaphragm, cervical cap, or contraceptive sponge. Talk to your healthcare provider about birth control methods that may be right for you during this time.

If you inadvertently become pregnant while taking Braftovi, tell your healthcare provider right away.

Breastfeeding

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

How should I take Braftovi?

Take Braftovi exactly as prescribed by your healthcare provider. Follow all directions on the Braftovi Package Insert. Your healthcare provider may occasionally change your dose.

• Take Braftovi 1 time a day
• Braftovi may be taken with or without food.
• You may need to take multiple capsules for one complete dose. Follow your healthcare provider's dosing instructions very carefully.
• Avoid grapefruit during treatment with Braftovi. Grapefruit products may increase the amount of Braftovi in your body.

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

If you stop treatment with Mektovi or Erbitux, talk to your healthcare provider about your Braftovi treatment. Your dose may need to be changed or stopped. 

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

Braftovi dosing information

Usual adult Braftovi dose for melanoma or NSCLC

• Braftovi 450 mg orally once a day in combination with Mektovi.

Usual adult Braftovi dose for colorectal cancer

• Braftovi 300 mg orally once daily in combination with Erbitux and mFOLFOX6.
• Braftovi 300 mg orally once daily in combination with Erbitux for previously treated colorectal cancer.

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.

Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.

What happens if I overdose?

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

What to avoid

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

What other drugs will affect Braftovi?

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

• Strong or moderate CYP3A4 inhibitors, such as clarithromycin, nefazodone, itraconazole, ketoconazole, atazanavir, darunavir, indinavir, lopinavir, nelfinavir, ritonavir, or saquinavir. Avoid coadministration, but if unavoidable, reduce the dosage of Braftovi
• Strong or moderate CYP3A4 inducers, such as phenobarbital, phenytoin, rifampicin, St. John's Wort, or glucocorticoids. Avoid coadministration.
• Sensitive CYP3A4 substrates, such as lenacapavir or hormonal contraceptives. Coadministration may increase the toxicity or decrease the efficacy of these agents. Avoid hormonal contraceptives.
• Substrates of OATP1B1, OATP1B3, or BCRP transporters, such as statins, rifampicin, bosentan, valsartan, and thyroid hormones. Dose reductions may be required.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Store Braftovi at room temperature, 20°C to 25°C (68°F to 77°F).

Do not use it if the safety seal under the cap is broken or missing. Do not remove the desiccant. Protect from moisture.

Keep the container tightly closed and out of reach of children.

Braftovi ingredients

Active: encorafenib 75mg

Inactive: copovidone, poloxamer 188, microcrystalline cellulose, succinic acid, crospovidone, colloidal silicon dioxide, magnesium stearate (vegetable origin).

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

Available as 75 mg capsules.

Who makes Braftovi?

Array BioPharma Inc. makes Braftovi.

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Further information

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

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