HOW TO TAKE BRAFTOVI + MEKTOVI

BRAFTOVI (encorafenib) is an oral medicine taken one time per day. MEKTOVI (binimetinib) is taken two times per day. Take BRAFTOVI at the same time each day with either the morning or evening dose of MEKTOVI.

BRAFTOVI

ONCE DAILY

six 75 mg BRAFTOVI (encorafenib) capsules icon

Six (75-mg) BRAFTOVI capsules

MEKTOVI

1ST DOSE

MEKTOVI (binimetinib) tablets dosing icon

Three (15-mg) MEKTOVI tablets

About

12 HOURS

after the first dose

2ND DOSE

MEKTOVI (binimetinib) tablets dosing icon

Three (15-mg) MEKTOVI tablets

  • Do not change your dose or stop taking either medicine unless your doctor tells you to. If you develop certain side effects, your doctor may change your dose, temporarily stop, or completely stop your treatment with either medicine or both
  • If you stop treatment with BRAFTOVI, talk to your doctor about whether your MEKTOVI treatment may need to be stopped
  • If you stop treatment with MEKTOVI, talk to your doctor 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.

If you miss a dose of MEKTOVI

Take your dose as soon as you remember. If it is within 6 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.

IMPORTANT THINGS TO REMEMBER WHEN TAKING
BRAFTOVI + MEKTOVI

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 and MEKTOVI at the same time every day.

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Take with or without food

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

grapefruit icon

Avoid grapefruit

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

thermometer icon

Store in a dry place

Store BRAFTOVI and MEKTOVI in their original bottles and in a dry place at room temperature. Keep the bottles closed tightly to protect them from moisture.

hand with capsule and tablet and rx bottle for BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)

Take it at home or on the go

BRAFTOVI + MEKTOVI is not an infusion, and it does not need to be refrigerated. That means you can take it at home or on the go.

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.

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BRAFTOVI + MEKTOVI PATIENT BROCHURE

Learn more about BRAFTOVI + MEKTOVI, including clinical trial results, dosing information, and the support options available to you throughout treatment.

English

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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 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.

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.