ZELBORAF Access Solutions
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Important Safety Information & Indication
Unresectable or Metastatic Melanoma
ZELBORAF® (vemurafenib) is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test.
Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma.
ZELBORAF® is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.
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
- 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
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.