LEARN ABOUT POSSIBLE SERIOUS SIDE EFFECTS

Each person responds differently to treatment, so make sure to talk to your doctor about how youre feeling. This is a summary of important risk information about BRAFTOVI (encorafenib) + cetuximab. If you have any of these symptoms while taking BRAFTOVI + cetuximab, 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.

heart icon

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.

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

The most common side effects

The most common side effects that people experienced in a clinical trial while taking BRAFTOVI + cetuximab 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.

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.

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.

Diarrhea

Your doctor may suggest you take over-the-counter anti-diarrheal medicine to help, but its 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.

Acne-like rash

Your doctor 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.

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.

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.

Pain or swelling of your 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.

Rash

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

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

capsule and tablet icon

TAKING
BRAFTOVI + CETUXIMAB

Learn how to take BRAFTOVI + cetuximab and important tips to remember when starting treatment.

learn how

IMPORTANT SAFETY
INFORMATION AND USE

FIND OUT MORE

COLLAPSE

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a medicine called cetuximab for the treatment of adults with cancer of their 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
  • 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 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.

IMPORTANT SAFETY INFORMATION

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

  • Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI or 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, 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
  • Muscle problems (rhabdomyolysis). MEKTOVI, when taken with BRAFTOVI, 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
  • Bleeding problems. BRAFTOVI, when taken with MEKTOVI or cetuximab, 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
  • Blood clots. MEKTOVI, when taken with BRAFTOVI, 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
  • 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 with MEKTOVI or 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 during treatment with BRAFTOVI with MEKTOVI or cetuximab. These symptoms may be related to QT prolongation
  • Lung or breathing problems. MEKTOVI, when taken with BRAFTOVI, 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

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

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 provider 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 last dose of BRAFTOVI
  • 3 days after the last 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 for melanoma include: fatigue, nausea, diarrhea, vomiting, stomach-area (abdominal) pain, and pain or swelling of your joints (arthralgia).

The most common side effects of BRAFTOVI when taken in combination with cetuximab for CRC include: fatigue, nausea, diarrhea, acne-like rash (dermatitis acneiform), stomach-area (abdominal) pain, decreased appetite, pain or swelling of your joints (arthralgia), and rash.

The most common side effects of BRAFTOVI when taken with MEKTOVI for NSCLC include: fatigue, nausea, diarrhea, muscle or joint pain, vomiting, stomach-area (abdominal) pain, blurred vision, loss of vision, or other vision changes, constipation, shortness of breath, rash, and cough.

Before taking BRAFTOVI in combination with MEKTOVI or cetuximab, 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 of 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 or visit www.fda.gov/medwatch. You may also report side effects to Pfizer Inc. at 1-800-438-1985.

For BRAF positive metastatic melanoma, please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Medication Guide, for additional information.

For BRAF positive metastatic colorectal cancer, please see BRAFTOVI full Prescribing Information, including Medication Guide, for additional information.

For BRAF positive metastatic non-small cell lung cancer, please see both BRAFTOVI full Prescribing Information, including Medication Guide, and MEKTOVI full Prescribing Information, including Medication Guide, for additional information.

What is BRAFTOVI and MEKTOVI?

BRAFTOVI (encorafenib) is a prescription medicine used:

  • in combination with a medicine called cetuximab for the treatment of adults with cancer of their 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
  • 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 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) is a prescription medicine used:

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:

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 a medicine called cetuximab for the treatment of adults with cancer of their 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
  • 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) is a prescription medicine used:

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 a medicine called cetuximab for the treatment of adults with cancer of their 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
  • 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) is a prescription medicine used:

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 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
  • in combination with a medicine called cetuximab for the treatment of adults with cancer of their 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
  • in combination with MEKTOVI 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, 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.