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

Risk of new skin cancers. BRAFTOVI, when used alone or with MEKTOVI, 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. BRAFTOVI, when taken with MEKTOVI, can cause heart problems. 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. BRAFTOVI, when taken with MEKTOVI, can cause 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, 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. BRAFTOVI, when taken with MEKTOVI, can cause 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 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 and MEKTOVI. 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.

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 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.

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 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 + MEKTOVI, 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.

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 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.

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

IMPORTANT SAFETY
INFORMATION AND USE

FIND OUT MORE

COLLAPSE

IMPORTANT SAFETY INFORMATION

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

Risk of new skin cancers. BRAFTOVI, when used alone, with MEKTOVI, with cetuximab and mFOLFOX, 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, 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, with cetuximab and mFOLFOX6, or with 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
- nose bleeds

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, with cetuximab and mFOLFOX6, or 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 during treatment with BRAFTOVI with MEKTOVI, with cetuximab and mFOLFOX6, or with 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.

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.

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

2 weeks after the last dose of BRAFTOVI
3 days after the last dose of MEKTOVI

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 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 and mFOLFOX6 for colorectal cancer 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 for colorectal cancer 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, cetuximab and mFOLFOX6, 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

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

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

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

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.

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IMPORTANT SAFETY INFORMATION

What is BRAFTOVI + MEKTOVI?

What is BRAFTOVI + MEKTOVI?

IMPORTANT SAFETY INFORMATION

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI?

What is BRAFTOVI?

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI + MEKTOVI?

What is BRAFTOVI and MEKTOVI?

What is BRAFTOVI + MEKTOVI?

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