Important Safety Information

WARNINGS AND PRECAUTIONS

The following can occur in patients treated with ZELBORAF:

• New primary malignancies including cutaneous squamous cell carcinoma, noncutaneous 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 injury leading to functional hepatic impairment (including coagulopathy or other organ dysfunction); increases in transaminases and bilirubin when concurrently administered with ipilimumab
• Photosensitivity
• Ophthalmologic reactions
• Embryo-fetal toxicity
  
• Radiation sensitization and radiation recall, including fatal cases in patients with visceral involvement
• Renal failure, including acute interstitial nephritis and acute tubular necrosis
• Dupuytren’s contracture and plantar fascial fibromatosis

DRUG INTERACTIONS

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 accompanying Full Prescribing Information for additional Important Safety Information.