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.

Indication

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

WARNINGS AND PRECAUTIONS

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 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

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 Full Prescribing Information for additional Important Safety Information.