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Zelboraf (Vemurafenib) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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)The intensity of clinical adverse events graded by the Common Terminology Criteria for Adverse Events v4.0 (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

DOSAGE FORMS AND STRENGTHS

Film-coated tablet: 240 mg

HOW SUPPLIED/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 20C - 25C (68F - 77F); excursions permitted between 15C and 30C (59F and 86F), 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.

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