Generic name: vemurafenib
Dosage form: tablet, film coated
This dosage information does not include all the information needed to use Zelboraf safely and effectively. See full prescribing information for Zelboraf.
The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.
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 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)
â€‹Do not dose reduce to below 480 mg twice daily.