How to take the BRAFTOVI combination therapy

BRAFTOVI (encorafenib) is a medicine you take by mouth one time per day. Cetuximab and chemotherapy (mFOLFOX6) are infusions administered by a healthcare provider. Take BRAFTOVI exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.

Once-daily oral treatment

icon of four oral BRAFTOVI (encorafenib) capsules

BRAFTOVI

Take four (75-mg) capsules by mouth once a day.

Infusion therapy

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Cetuximab

Your healthcare provider will administer your cetuximab infusion.

Infusion therapy

cetuximab infusion therapy iv bag icon

Chemotherapy
(mFOLFOX6)

Your healthcare provider will administer your chemotherapy infusion of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin).

If you stop treatment with cetuximab or chemotherapy (mFOLFOX6), talk to your healthcare provider about your BRAFTOVI treatment. Your BRAFTOVI dose may need to be changed or stopped.

What to do if you miss a dose

If you miss a dose of BRAFTOVI, take your dose as soon as you remember. If it is within 12 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.

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

Before taking BRAFTOVI

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

Important things to remember when taking BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6)

Tell your doctor 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. When starting a new treatment, it can be helpful to make it part of your daily routine.

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Set treatment reminders

Make it a habit by setting an alarm on your phone or watch to remind you to take your BRAFTOVI at the same time every day.

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Take with or without food

Take BRAFTOVI with or without a meal or snack. There is no need to fast.

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Avoid grapefruit

Avoid consuming grapefruit when taking BRAFTOVI. Grapefruit products may increase the amount of BRAFTOVI in your body.

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Store in a dry place

Store BRAFTOVI in its original bottle and in a dry place at a room temperature. Keep the bottle closed tightly to protect it from moisture. It does not need to be refrigerated. That means you can take it at home or on the go.

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Drink enough water

Staying hydrated is important, especially for people living with cancer. Talk with your doctor about how much water you should drink daily.

Remember, this website is being provided for your information only and does not replace the medical advice of your doctor. Be sure to consult your doctor regarding any questions or concerns you may have about your specific medical condition or treatment plan.

open book icon with down arrow to download BRAFTOVI (encorafenib) + MEKTOVI (binimetinib) patient brochure

BRAFTOVI PATIENT BROCHURE

Learn more about BRAFTOVI + cetuximab + chemotherapy (mFOLFOX6), including clinical trial results, dosing information, and the support options available to you throughout treatment.

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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.