What should I avoid during treatment with COTELLIC and ZELBORAF?

Avoid sunlight during treatment with COTELLIC and ZELBORAF. COTELLIC and ZELBORAF can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:

• When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs.
• Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

What are the possible side effects of COTELLIC and ZELBORAF?

COTELLIC and ZELBORAF may cause serious side effects, including:

• Risk of new skin cancers. COTELLIC in combination with ZELBORAF may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma, or basal cell carcinoma). New melanoma lesions have occurred in people who take ZELBORAF.

• Check your skin regularly and tell your healthcare provider right away if you have any skin changes including:
  • 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 you start taking COTELLIC and ZELBORAF, and every 2 months during treatment with COTELLIC and ZELBORAF. Your healthcare provider may continue to check your skin for 6 months after you stop taking COTELLIC and ZELBORAF.

• Risk of other cancers. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (non-cuSCC). Talk with your healthcare provider about your risk for these 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 with COTELLIC and ZELBORAF.

• Bleeding problems. COTELLIC can cause serious bleeding problems.
  Call your healthcare provider and get medical attention right away if you get any signs of bleeding, including:
  • red or black stools (looks like tar)
  • blood in your urine
  • headaches
  • cough up or vomit blood
  • stomach (abdominal) pain
  • unusual vaginal bleeding
  • dizziness or weakness

• Heart problems. Your healthcare provider should do tests before and during treatment to check your heart function. Tell your healthcare provider if you get any of these signs and symptoms of heart problems:
  • persistent coughing or wheezing
  • shortness of breath
  • swelling of your ankles and feet
  • tiredness
  • increased heart rate

• Allergic reactions can happen while taking ZELBORAF, and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction:
  • rash or redness all over your body
  • trouble breathing or swallowing
  • throat tightness or hoarseness
  • feel faint
  • fast heartbeat

• Severe rash and other severe skin reactions. Tell your healthcare provider right away if you get any of these symptoms:
  • a rash that covers a large area of your body
  • blisters
  • peeling skin
  
  Stop taking ZELBORAF and call your doctor right away if you get a skin rash with any of the following symptoms, because you may have a severe skin reaction:
  • blisters on your skin
  • blisters or sores in your mouth
  • peeling of your skin
  • fever
  • redness or swelling of your face, hands, or soles of your feet

• Eye problems. Tell your healthcare provider right away if you get any of these symptoms:
  • blurred vision
  • partly missing vision or loss of vision
  • see halos
  • eye pain, swelling, or redness
  • any other vision changes
  Your healthcare provider should check your eyes if you notice any of the symptoms above.

• Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your doctor should do tests before you start taking ZELBORAF and during your treatment with ZELBORAF to check the electrical activity of your heart and your body salts (electrolytes). Tell your doctor right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast while taking ZELBORAF. These may be symptoms related to QT prolongation.
  

• Liver problems or liver injury. Your healthcare provider should do blood tests to check your liver function before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
  • yellowing of your skin or the white of your eyes
  • dark or brown (tea color) urine
  • nausea or vomiting
  • feeling tired or weak
  • loss of appetite
  • pain in the right side of your stomach

• Muscle problems (rhabdomyolysis). COTELLIC can cause muscle problems that can be severe. Treatment with COTELLIC may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare provider should do a blood test to check your levels of CPK before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
  • muscle aches or pain
  • muscle spasms and weakness
  • dark, reddish urine

• Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with COTELLIC and ZELBORAF is common and can sometimes be severe. Tell your healthcare provider if you get any of these symptoms:
  • red, painful, itchy skin that is hot to touch
  • sun rash
  • skin irritation
  • bumps or tiny papules
  • thickened, dry, wrinkled skin

• Worsening side effects from radiation treatment that can sometimes be severe or lead to death. Tell your healthcare provider if you have had or are planning to receive radiation therapy.

• Kidney injury. Your healthcare provider should do blood tests to check your kidney function before you start taking ZELBORAF and during treatment.

• Connective tissue disorders. Tell your healthcare provider if you develop an unusual thickening of the palms of your hands along with tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.