Information for Healthcare Providers / Patients

Zelboraf® (vemurafenib)

Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

What it Treats

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 has a certain type of abnormal BRAF gene.

Your healthcare provider will perform a test to make sure that ZELBORAF is right for you. ZELBORAF is not used to treat melanoma with a normal BRAF gene.

Important Safety Information

ZELBORAF can cause serious side effects, including risk of cancers. ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Talk with your healthcare provider about your risk for these cancers. Check your skin and tell your healthcare provider about skin changes, including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that you get while taking ZELBORAF.

While taking ZELBORAF, you should avoid sunlight. 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.

Possible serious side effects of ZELBORAF include severe allergic reactions, severe skin reactions, potentially life-threatening changes in the electrical activity of your heart called QT prolongation, liver injury, eye problems, worsening side effects from radiation treatment, and kidney injury.

Tell your healthcare provider if you are pregnant, or plan to become pregnant, as ZELBORAF can harm your unborn baby. Females who are able to become pregnant should use effective birth control during ZELBORAF treatment and for 2 weeks after the final dose.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with ZELBORAF and for 2 weeks after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time.

Tell your healthcare provider about all the medicines you take.

Common side effects of ZELBORAF include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts.

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

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

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

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Patient Access

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