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• 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.

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.