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) + cetuximab + chemotherapy (mFOLFOX6). If you have any of these symptoms while taking BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6), call your doctor immediately. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with BRAFTOVI if you have certain side effects.

triangle with exclamation point representing the potential risk of new cancers

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.

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Heart problems, including heart failure

Symptoms included feeling like your heart is pounding or racing; shortness of breath; swelling in your hands, ankles, legs, or feet; feeling faint or light-headed.

liver icon

Liver problems

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

blood icon representing the potential side effect of bleeding problems

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; nose bleeds.

eye icon representing the possible side effect of eye problems

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.

icon of heart rate line representing the potential side effects of QT prolongation problems

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.

Icon of triangle and exclamation point representing the potential side effect of risk of harm to unborn babies

Risk of harm to unborn babies

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

These are not all of the possible side effects of BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6).
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. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

The most common side effects

The most common side effects that people experienced in a clinical trial while taking BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6) are below.

Remember, the information below does not replace directions from your doctor. Always talk to your doctor about side effects and ways you may be able to manage them. Your doctor may change your dose or stop treatment temporarily or completely. Before taking any medicines, speak with your doctor. Click on the arrows below for information about side effects to discuss with your doctor.

Numbness, tingling, or burning in your hands or feet (peripheral neuropathy)

Talk to your doctor if you experience any symptoms related to peripheral neuropathy (nerve pain). Your doctor may suggest pain medicine or recommend some practices, such as acupuncture, massage, physical therapy, or yoga.

Nausea

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

Fatigue

Talk to your doctor if you experience fatigue (tiredness or lack of energy). They may recommend daily exercise or other activities that may help reduce fatigue.

Rash

Tell your doctor about any rashes right away. They may recommend soaps, creams, or lotions to soothe it.

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.

Decreased appetite

Discuss with your doctor 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.

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.

Bleeding (hemorrhage)

Talk with your doctor about different ways to manage bleeding and possibly prevent it. They may recommend not taking certain over-the-counter medicines that can increase your risk of bleeding. They may also suggest using a very soft toothbrush and wearing shoes, even when you’re indoors.

Stomach-area (abdominal) pain

Talk to your doctor 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.

Fever

Usually, a temperature at or above 100.4°F for at least 1 hour is considered a fever. Talk to your doctor about what temperature they consider a fever and how to manage it. If you have a fever, your doctor may recommend certain over-the-counter medicines to treat it.

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

These are not all of the possible side effects of BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6).
Call your doctor 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 www.fda.gov/medwatch or call 1-800-FDA-1088.

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TAKING THE BRAFTOVI combination therapy

Learn how to take BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6) and important tips to remember when starting treatment.

 learn how

IMPORTANT SAFETY
INFORMATION AND USE

FIND OUT MORE

COLLAPSE

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.
  • BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
    • 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.

IMPORTANT SAFETY INFORMATION

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

  • Risk of new skin cancers. BRAFTOVI combination therapy 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, 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 will check your heart function before and during treatment. Tell 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 in your hands, ankles, legs, or feet
    • feeling faint or light-headed
  • Liver problems. Your healthcare provider will perform blood tests to check your liver function before and during treatment. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or your eyes
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite
    • tiredness
    • bruising
    • bleeding
  • Bleeding problems. BRAFTOVI combination therapy 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
    • cough 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. Your healthcare provider should perform an eye exam regularly during treatment. 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 combination therapy 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 during treatment with BRAFTOVI combination therapy. These symptoms may be related to QT prolongation

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

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 provider 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 last dose of BRAFTOVI.

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.

The most common side effects of BRAFTOVI when taken in combination with cetuximab and mFOLFOX6 include: numbness, tingling, or burning in your hands or feet (peripheral neuropathy), nausea, fatigue, rash, diarrhea, decreased appetite, vomiting, bleeding (hemorrhage), stomach-area (abdominal) pain, and fever.

The most common side effects of BRAFTOVI when taken in combination with cetuximab include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), stomach-area (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 of 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-1088 or visit www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

What is BRAFTOVI?
  • BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.
  • BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
    • 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.

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

What is BRAFTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):

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

BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.

BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:

  • 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.

What is BRAFTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):

BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.

BRAFTOVI is a prescription medicine used in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:

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.

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.

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 test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

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

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a prescription medicine called MEKTOVI (binimetinib) to treat adults 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
  • in combination with medicines called cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) to treat people with cancer of the colon or rectum (colorectal cancer):
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene

BRAFTOVI in combination with cetuximab and mFOLFOX6 was approved based on response rate and how long patients’ responses lasted. There is ongoing evaluation of clinical benefit of BRAFTOVI in combination with cetuximab and mFOLFOX6.

  • in combination with a medicine called cetuximab to treat adults with cancer of the colon or rectum (colorectal cancer) after past treatment:
    • that has spread to other parts of the body, and
    • that has a certain type of abnormal “BRAF” gene
  • in combination with MEKTOVI to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):
    • 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 melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI or BRAFTOVI with MEKTOVI is right for you.

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

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of skin cancer called melanoma:

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.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults 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.

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

BRAFTOVI should not be used to treat people with wild-type BRAF NSCLC. 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.

What is BRAFTOVI + MEKTOVI?

BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) are prescription medicines used together to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

  • 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 wild-type BRAF NSCLC. Your healthcare provider will perform a test to make sure that BRAFTOVI with MEKTOVI is right for you.

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