Zelboraf
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Zelboraf
INDICATIONS
ZELBORAF™ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test.
Limitation of Use: ZELBORAF is not recommended for use in patients with wild-type BRAF melanoma.
DOSAGE AND ADMINISTRATION
Recommended Dose
The recommended dose of ZELBORAF is 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal.
ZELBORAF tablets should be swallowed whole with a glass of water. ZELBORAF tablets should not be chewed or crushed.
Duration of treatment
It is recommended that patients are treated with ZELBORAF until disease progression or unacceptable toxicity occurs.
Missed doses
If a dose is missed, it can be taken up to 4 hours prior to the next dose to maintain the twice daily regimen. Both doses should not be taken at the same time.
Dose Modifications
Management of symptomatic adverse drug reactions or prolongation of QTc may require dose reduction, treatment interruption, or treatment discontinuation of ZELBORAF (Table 1). Dose modifications or interruptions are not recommended for cutaneous squamous cell carcinoma (cuSCC) adverse reactions [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Dose reductions resulting in a dose below 480 mg twice daily are not recommended.
Table 1: Dose Modification Information
| Grade (CTC-AE)* | Recommended ZELBORAF Dose Modification |
| Grade 1 or Grade 2 (tolerable) | Maintain ZELBORAF at a dose of 960 mg twice daily. |
| Grade 2 (Intolerable) or Grade 3 | |
| 1st Appearance | Interrupt treatment until grade 0-1. Resume dosing at 720 mg twice daily. |
| 2nd Appearance | Interrupt treatment until grade 0-1. Resume dosing at 480 mg twice daily. |
| 3rd Appearance | Discontinue permanently |
| Grade 4 | |
| 1st Appearance | Discontinue permanently or interrupt ZELBORAF treatment until grade 0-1. Resume dosing at 480 mg twice daily. |
| 2nd Appearance | Discontinue permanently |
| *The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE) | |
HOW SUPPLIED
Dosage Forms and Strengths
Film-coated tablet: 240 mg
ZELBORAF (vemurafenib) is supplied as 240 mg film-coated tablets with VEM debossed on one side in single bottle of 120 count. The following packaging configuration is available:
NDC 50242-090-01
Storage and Stability: Store at room temperature 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F), See USP Controlled Room Temperature. Store in the original container with the lid tightly closed.
Disposal of unused/expired medicines: The release of Pharmaceuticals in the environment should be minimized. Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Use established "collection systems", if available in your location.
Distributed by: Genentech USA Inc, A member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Issued: August 2011.
Last reviewed on RxList: 8/29/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Zelboraf Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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