Important Safety Information & Indication
What it Treats
Important: 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 and ZELBORAF 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 and ZELBORAF can harm your unborn baby. Females who are able to become pregnant should use effective birth control during treatment with COTELLIC and for 2 weeks after the final dose of COTELLIC.
- Do not breastfeed during treatment and for 2 weeks after the final dose of COTELLIC. Talk to your heallthcare provider about the best way to feed your baby during this time.
- Tell your healthcare provider about all the medicines you take. Some types of medicines will 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 and ZELBORAF.
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.