ZELBORAF Indication and Important Safety Information
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.
Important Safety Information
The following can occur in patients treated with ZELBORAF:
- New primary malignancies including cutaneous squamous cell carcinoma, non-cutaneous squamous cell carcinoma, new primary melanoma, and other malignancies
- Tumor promotion in BRAF wild-type melanomas
- Serious hypersensitivity reactions including anaphylaxis
- Severe dermatologic reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis
- QT prolongation
- Hepatotoxicity including liver laboratory abnormalities, and, when concurrently administered with ipilimumab, increases in transaminases and bilirubin
- Ophthalmologic reactions
ZELBORAF can cause fetal harm when administered to a pregnant woman based on its mechanism of action.
The most common adverse reactions of any grade (≥30%) reported were arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma.
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 accompanying full Prescribing Information for additional important safety information.
ZELBORAF® and the Access Solutions logo are registered trademarks of Genentech, Inc.