• HEALTHCARE PROFESSIONALS
  • Important Safety Information
  • View information on BRAFTOVI for other FDA-approved uses

Learn about possible serious side effects

Each person responds differently to treatment, so make sure to talk to your doctor about how you’re feeling. This is a summary of important risk information about BRAFTOVI (encorafenib) + MEKTOVI (binimetinib). If you experience any of these symptoms while taking BRAFTOVI + MEKTOVI, call your doctor immediately.

Risk of new skin cancers

Symptoms included new warts; skin sores or reddish bumps that bleed or do not heal; change in size or color of a mole.

Heart problems, including heart failure

Symptoms included feeling like your heart is pounding or racing; shortness of breath; swelling in the ankles and feet; feeling light‑headed.

Blood clots

Can lead to death. Symptoms included chest pain; sudden shortness of breath or trouble breathing; pain in your legs with or without swelling; swelling in your arms and legs; a cool, pale arm or leg.

Bleeding problems

Can lead to death. Symptoms included headaches, dizziness, or feeling weak; coughing up blood or blood clots; vomiting blood or your vomit looks like “coffee grounds”; red or black stools that look like tar.

Eye problems

Symptoms included blurred vision, loss of vision, or other vision changes; seeing colored dots; seeing halos (blurred outline around objects); eye pain, swelling, or redness.

Lung or breathing problems

Symptoms included shortness of breath and cough.

Liver problems

Symptoms included yellowing of the skin or white part of the eyes (jaundice); dark or brown (tea-colored) urine; nausea and vomiting; loss of appetite.

Muscle problems (rhabdomyolysis)

Symptoms included weakness; muscle aches or pain; dark, reddish urine.

Changes in the electrical activity of your heart (QT prolongation)

Can be life-threatening. Symptoms included feeling faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast.

Risk of harm to unborn babies

Tell your doctor if you are pregnant or plan to become pregnant.

These are not all of the possible side effects with BRAFTOVI + MEKTOVI.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

The most common side effects

The most common side effects that people experienced in a clinical trial while taking BRAFTOVI + MEKTOVI are below. ClickTap on the  below for information about side effects to discuss with your doctor.

Remember, the information below does not replace directions from your doctor. Always talk to your healthcare team about side effects and ways to manage them. Your doctor may change your dose or stop treatment temporarily or completely. Before taking any medications, speak with your doctor.

Fatigue

Talk to your doctor if you experience fatigue. They may recommend daily exercise or other activities that may help reduce fatigue.

Headache

Tell your doctor about any headaches right away as they may be serious. They may suggest daily rest or other activities that may help reduce headaches.

Abdominal pain/nausea

Abdominal pain and nausea may be worse if your stomach is empty. Discuss your eating habits with your doctor to see how you can make adjustments. They may suggest avoiding foods that commonly cause abdominal pain and eating smaller meals throughout the day. They may also suggest an anti-nausea medicine.

Vomiting

It’s important to stay hydrated throughout treatment. Talk to your doctor about liquids and over-the-counter medicines that may help. Fruit juices, ginger ale, water, and sports drinks are often recommended as they can help prevent dehydration.

Pain or swelling of joints

Your doctor may recommend physical therapy or medicine to reduce swelling and inflammation. They may also suggest light stretching and hot or cold compresses to help reduce joint pain.

Fever or chills

Talk to your doctor about any fever or chills right away. They may recommend rest, fluids, and over-the-counter medicines. As soon as you sense a fever coming on, check your temperature and keep a record of it in your journal.

Rash

Tell your doctor about any rashes right away. They may recommend creams or lotions to soothe it, or wearing clothing of a different material, as well as avoiding excess time in the sun.

Diarrhea

Your doctor may suggest you take over-the-counter anti-diarrheal medicine to help, but it’s also always important to stay hydrated. Sports drinks are often recommended as they can help replace electrolytes and salts. Report diarrhea to your doctor right away.
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IMPORTANT SAFETY INFORMATION AND INDICATION

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IMPORTANT SAFETY INFORMATION AND INDICATION

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) may cause serious side effects, including:

  • Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, 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 and every 2 months during treatment, and for up to 6 months after you stop treatment 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.

  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with MEKTOVI. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:

    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling of your ankles and feet
    • feeling light-headed

  • Blood clots. MEKTOVI can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:

    • chest pain
    • sudden shortness of breath or trouble breathing
    • pain in your legs with or without swelling
    • swelling in your arms and legs
    • a cool, pale arm or leg

  • Bleeding problems. BRAFTOVI, when taken with MEKTOVI, 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. MEKTOVI can cause serious eye problems that might lead to blindness. Call 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

  • Lung or breathing problems. MEKTOVI can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:

    • shortness of breath
    • cough

  • Liver problems. Your healthcare provider should perform blood tests to check your liver function before and during treatment with MEKTOVI. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:

    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite

  • Muscle problems (rhabdomyolysis). MEKTOVI can cause muscle problems that can be severe. MEKTOVI may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should perform a blood test to check your CPK levels before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms:

    • weakness
    • muscle aches or pain
    • dark, reddish urine

  • 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 and during your treatment to check your body salts (electrolytes). Tell your healthcare provider right away if you feel faint, light-headed, dizzy, or if you feel your heart beating irregularly or fast while taking BRAFTOVI with MEKTOVI. These symptoms may be related to QT prolongation.

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI and MEKTOVI can harm your unborn baby. Females who are able to become pregnant should use effective non-hormonal birth control (contraception) during and for at least:

    • 2 weeks after the last dose of BRAFTOVI
    • 30 days after the last dose of MEKTOVI
    • Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with BRAFTOVI.
    • Your healthcare team will do a pregnancy test before you start taking BRAFTOVI and MEKTOVI. Tell your healthcare provider right away if you become pregnant or think you might become pregnant during treatment.

Talk to your healthcare team if you are breastfeeding or plan to breastfeed. It is not known if either treatment passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and MEKTOVI and for:

    • 2 weeks after the final dose of BRAFTOVI
    • 3 days after the final dose of MEKTOVI

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

The most common side effects of BRAFTOVI when taken with MEKTOVI, include: fatigue, nausea, diarrhea, vomiting, abdominal pain, and pain or swelling of your joints.

Before taking BRAFTOVI + MEKTOVI, 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
  • have had blood clots
  • have lung or breathing problems
  • have any muscle problems
  • have high blood pressure (hypertension)
  • are pregnant or plan to become pregnant

  • are breastfeeding or plan to breastfeed

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 BRAFTOVI or other medicines work. You should also avoid grapefruit products during treatment with BRAFTOVI.

These are not all the possible side effects of BRAFTOVI and MEKTOVI. 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 Pfizer Inc. at 1-800-438-1985.

Please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Patient Information, for additional information.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI and MEKTOVI are prescription medicines used together 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 that BRAFTOVI + MEKTOVI is right for you.

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

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What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together 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” (V600E or V600K) gene

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

It is not known if BRAFTOVI or MEKTOVI is safe and effective in children.

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