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
If your healthcare provider prescribes ZELBORAF (vemurafenib), also read the Medication Guide that comes with ZELBORAF.
What is COTELLIC?
COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, 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.
Your healthcare provider will perform a test to make sure that COTELLIC is right for you.
It is not known if COTELLIC is safe and effective in children under 18 years of age.
Important Safety Information
- Avoid sunlight during treatment with COTELLIC. COTELLIC can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. 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
- COTELLIC may cause serious side effects, including risk of new skin cancers, bleeding problems, heart problems, severe rash, eye problems, liver problems, muscle problems (rhabdomyolysis), and skin sensitivity to sunlight (photosensitivity)
- Tell your doctor if you are pregnant or plan to become pregnant, as COTELLIC can harm your unborn baby. Patients who take COTELLIC should use effective methods of birth control during treatment, and for 2 weeks after the final dose of COTELLIC
- Do not breastfeed during treatment with COTELLIC and for 2 weeks after the final dose
- Tell your healthcare provider about all the medicines you take. Certain medicines may affect the blood levels of COTELLIC
- Common side effects of COTELLIC include diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting. COTELLIC can also cause changes in blood test results
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COTELLIC.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see Full COTELLIC Prescribing Information and Patient Information for additional Important Safety Information.