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Learn about possible serious side effects

Each person responds differently to treatment, so make sure to talk to your healthcare provider about how you’re feeling. This section outlines the serious side effects that people experienced in a clinical trial.
If you experience any of these symptoms while taking BRAFTOVI (encorafenib) in combination with cetuximab, it's important to call your healthcare provider 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.

Bleeding problems

Can lead to death. Symptoms included headaches, dizziness, or feeling weak; coughing up blood or blood clots; vomiting blood or vomit that 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.

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

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

Tell your healthcare team if you are pregnant or plan to become pregnant. BRAFTOVI can harm your unborn baby.

These are not all of the possible side effects with BRAFTOVI + cetuximab. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

 
 
 
 
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The most common side effects of BRAFTOVI + cetuximab

The most common side effects that people taking BRAFTOVI (encorafenib) in combination with cetuximab experienced in a clinical trial are below. Tap on Click on the plus sign icon below for information about side effects to discuss with your healthcare provider.

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

FATIGUE

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

NAUSEA

Nausea may be worse if your stomach is empty, so discuss your eating habits with your healthcare provider. They may also suggest an anti-nausea medicine.

DIARRHEA

Your healthcare provider 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 healthcare provider right away.

ACNE-LIKE RASH

Your healthcare provider may recommend protecting your skin from the sun and using moisturizers every day. They may recommend or prescribe creams or other medicines to treat these rashes.

ABDOMINAL PAIN

Talk to your healthcare provider about your eating habits and how you can make adjustments. They may suggest avoiding foods that commonly cause abdominal pain and eating smaller meals throughout the day.

DECREASED APPETITE

Discuss with your healthcare provider different ways you could increase your appetite. These may include eating balanced nutritious meals and eating small, frequent meals or snacks 6 to 8 times daily.

PAIN OR SWELLING OF JOINTS

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

RASH

Tell your healthcare provider about any rashes right away. They may recommend creams or lotions to soothe it.

These are not all of the possible side effects with BRAFTOVI + cetuximab. Call your healthcare provider for medical advice about side effects.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (US only). If you prefer, you may contact the US Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

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Important Safety Information and Indication

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Important Safety Information and Indication

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

  • Risk of new skin cancers. BRAFTOVI, when used alone or with cetuximab, 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.

  • Bleeding problems. BRAFTOVI, when taken with cetuximab, 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 cetuximab 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 cetuximab. These symptoms may be related to QT prolongation.

Tell your healthcare team if you 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 with BRAFTOVI and for 2 weeks after the last dose of BRAFTOVI.
  • 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. 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 BRAFTOVI passes into your breast milk. Do not breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose of BRAFTOVI.

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 in combination with cetuximab include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), abdominal pain, decreased appetite, pain or swelling of your joints (arthralgia), and rash.

Before taking BRAFTOVI, 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
  • 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088 or visit www.fda.gov/medwatch.

Please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI?

BRAFTOVI is a prescription medicine used:

  • in combination with a medicine called cetuximab, for the treatment of adults with cancer of your colon or rectum (colorectal cancer):

    • that has been previously treated, and
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

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

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