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IMPORTANT SAFETY INFORMATION

What is the most important information I should know about BRAFTOVI (encorafenib) and MEKTOVI (binimetinib)?

BRAFTOVI and MEKTOVI can cause serious side effects, including:

• Risk of new skin cancers. BRAFTOVI or BRAFTOVI when used with MEKTOVI can 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 or MEKTOVI taken with BRAFTOVI 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 or MEKTOVI taken with BRAFTOVI 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 or MEKTOVI taken with BRAFTOVI 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. BRAFTOVI or MEKTOVI taken with BRAFTOVI 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 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. These symptoms may be related to QT prolongation

• Lung or breathing problems. MEKTOVI (binimetinib), when taken with BRAFTOVI (encorafenib), 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.