Generic name: vemurafenib
Dosage form: tablet, film coated
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Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with ZELBORAF [see Warnings and Precautions (5.2)]. Information on FDA approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.
The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) orally every 12 hours with or without a meal. A missed dose can be taken up to 4 hours prior to the next dose.
Treat patients with ZELBORAF until disease progression or unacceptable toxicity occurs.
Do not take an additional dose if vomiting occurs after ZELBORAF administration, but continue with the next scheduled dose.
Do not crush or chew the tablets.
For Other Adverse Reactions:
Permanently discontinue ZELBORAF for any of the following:
- Grade 4 adverse reaction, first appearance (if clinically appropriate) or second appearance
- QTc prolongation > 500 ms and increased by > 60 ms from pre-treatment values [see Warnings and Precautions (5.5)]
Withhold ZELBORAF for NCI CTCAE (v4.0) intolerable Grade 2 or greater adverse reactions.
- Upon recovery to Grade 0–1, restart ZELBORAF at a reduced dose as follows:
- 720 mg twice daily for first appearance of intolerable Grade 2 or Grade 3 adverse reactions
- 480 mg twice daily for second appearance of Grade 2 (if intolerable) or Grade 3 adverse reactions or for first appearance of Grade 4 adverse reaction (if clinically appropriate)
Do not dose reduce to below 480 mg twice daily.