This information does not take the place of talking to your doctor about your medical condition or your treatment with ZELBORAF.

What is ZELBORAF?

ZELBORAF is a prescription medicine used to treat 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.

It is not known if ZELBORAF is safe and effective in children under 18 years of age.

Important Safety Information

What is the most important information I should know about ZELBORAF?

ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). CuSCC usually does not spread to other parts of the body. Check your skin and tell your doctor right away about any skin changes, including a:

  • A new wart
  • A skin sore or reddish bump that bleeds or does not heal
  • A change in size or color of a mole

A doctor should check your skin before you start taking ZELBORAF and every 2 months while you are taking ZELBORAF to look for any new skin cancers. Your doctor may continue to check your skin for 6 months after you stop taking ZELBORAF.

What should I tell my doctor before taking ZELBORAF?

Before you start taking ZELBORAF, tell your doctor if you:

  • Have any heart problems, including a condition called long QT syndrome
  • Have liver or kidney problems
  • Have been told that you have low blood levels of potassium, calcium or magnesium
  • Plan to have surgical, dental, or other medical procedures
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. ZELBORAF may harm your unborn baby. Women who are able to become pregnant and men who take ZELBORAF should use birth control during treatment and for 2 months after stopping ZELBORAF. Talk to your doctor about birth control methods that may be right for you and tell your doctor right away if you become pregnant during treatment with ZELBORAF.
  • Are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take ZELBORAF or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and non- prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • Blood thinners
  • Antifungal medicines
  • Antibiotics
  • HIV medicines
  • Seizure medicines
  • Anti-depressants
  • Medicines to treat irregular heart beat

What should I avoid while taking ZELBORAF?

Avoid sunlight while you are taking ZELBORAF. 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 ZELBORAF?

  • Allergic reactions can happen while taking your ZELBORAF, and may be severe. Stop taking ZELBORAF and get medical help if you have any of these symptoms:
    • A rash or redness all over your body
    • Feel faint
    • Have trouble breathing or swallowing
    • Have throat tightness or hoarseness
    • Have a fast heartbeat
    • Have swelling of the face, lips, or tongue
  • Severe skin reactions. 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
  • 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, if your dose changes, at certain other times during treatment and after you stop treatment with ZELBORAF, to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG. 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
  • Abnormal liver function tests. Your doctor should do blood tests to check your liver function before you start taking ZELBORAF and during treatment. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
    • Your skin or the whites of your eyes turn yellow
    • You feel tired
    • Your urine turns dark or brown (tea color)
    • You have nausea or vomiting
    • You do not want to eat
    • Pain on the right side of your stomach
  • Eye problems. You should have your eyes examined before and while you are taking your ZELBORAF. Tell your doctor right away if you get these symptoms during treatment with ZELBORAF
    • Eye pain, swelling, or redness,
    • Blurred vision or other vision changes during treatment with ZELBORAF
  • New melanoma lesions. You may develop new melanoma lesions while taking ZELBORAF. Check your skin and tell your doctor right away about any skin changes.

The most common side effects include:

  • Joint pain
  • Rash
  • Hair loss
  • Tiredness
  • Sunburn or sun sensitivity
  • Nausea
  • Itching
  • Warts

These are not all of the possible side effects of ZELBORAF. Tell your doctor if you have any side effect that bothers you or does not go away. For more information about side effects, ask your doctor or pharmacist.

Call your doctor for medical advice about any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.