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Zelboraf

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Zelboraf

INDICATIONS

ZELBORAF®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 [see WARNINGS AND PRECAUTIONS].

DOSAGE AND ADMINISTRATION

Patient Selection

Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with ZELBORAF [see WARNINGS AND PRECAUTIONS]. Information on FDA approved tests for the detection of BRAF V600 mutations in melanoma is available at http://www.fda.gov/CompanionDiagnostics.

Recommended Dose

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.

Dose Modifications

For New Primary Cutaneous Malignancies: No dose modifications are recommended.

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]

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.

HOW SUPPLIED

Dosage Forms And Strengths

Tablet: 240 mg.

Storage And Handling

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. Initial US Approval: August 2011. PI Revision Date: February 2014

Last reviewed on RxList: 2/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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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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