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.
ZELBORAF® (vemurafenib) tablets are indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
ZELBORAF is not indicated for use in patients with wild-type BRAF melanoma.
WARNINGS AND PRECAUTIONS
The following can occur in patients treated with ZELBORAF:
Avoid concurrent use of ZELBORAF with strong CYP3A4 inhibitors, strong CYP3A4 inducers, and CYP1A2 and P-glycoprotein substrates with a narrow therapeutic window.
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed while taking ZELBORAF and for 2 weeks after the final dose.
Most Common Adverse Reactions
The most common adverse reactions of any grade (≥30%) reported were arthralgia (53%), rash (37%), alopecia (45%), fatigue (38%), photosensitivity reaction (33%), nausea (35%), pruritus (23%), and skin papilloma (21%).
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 for additional Important Safety Information.