Vemurafenib is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test, among other approved uses. MedsAcross supplies Vemurafenib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ZELBORAF ® is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ZELBORAF ® is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma
Source: US FDA prescribing information
Vemurafenib is a low molecular weight, orally available inhibitor of some mutated forms of BRAF serine- threonine kinase, including BRAF V600E. Vemurafenib also inhibits other kinases in vitro such as CRAF, ARAF, wild-type BRAF, SRMS, ACK1, MAP4K5, and FGR at similar concentrations. Some mutations in the BRAF gene including V600E result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation. Vemurafenib has anti-tumor effects in cellular and animal models of melanomas with mutated BRAF V600E.
Source: US FDA prescribing information
Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with ZELBORAF. Recommended dose: 960 mg orally twice daily taken approximately 12 hours apart with or without a meal.
Source: US FDA prescribing information
None. None
Source: US FDA prescribing information
New Primary Cutaneous Malignancies: Perform dermatologic evaluations prior to initiation of therapy, every 2 months while on therapy, and for up to 6 months following discontinuation of ZELBORAF. Manage with excision and continue treatment without dose adjustment. New Non-Cutaneous Squamous Cell Carcinoma: Evaluate for symptoms or clinical signs of new non-cutaneous SCC before initiation of treatment and periodically during treatment. Other Malignancies: Monitor patients receiving ZELBORAF closely for signs or symptoms of other malignancies. Tumor Promotion in BRAF Wild-Type Melanoma: Increased cell proliferation can occur with BRAF inhibitors. Serious Hypersensitivity Reactions including anaphylaxis and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS Syndrome): Discontinue ZELBORAF for severe hypersensitivity reactions.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the label: New Primary Malignancies Hypersensitivity Reactions Dermatologic Reactions QT Prolongation Hepatotoxicity Photosensitivity Ophthalmologic Reactions Radiation Sensitization and Radiation Recall Renal Failure Dupuytren's Contracture and Plantar Fascial Fibromatosis Melanoma: Most common adverse reactions (≥ 30%) are arthralgia, rash, alopecia, fatigue, photosensitivity reaction, nausea, pruritus, and skin papilloma. Erdheim-Chester Disease: Most common adverse reactions (>50%) are arthralgia, rash maculo-papular, alopecia, fatigue, electrocardiogram QT interval prolonged, and skin papilloma.
Source: US FDA prescribing information
Avoid concomitant administration of ZELBORAF with strong CYP3A4 inhibitors or inducers. CYP1A2 Substrates: ZELBORAF can increase concentrations of CYP1A2 substrates. Avoid concomitant use of ZELBORAF with CYP1A2 substrates with a narrow therapeutic window. If coadministration cannot be avoided, monitor closely for toxicities and consider dose reduction of CYP1A2 substrates.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Vemurafenib, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Zelboraf 240 mg tabletOral | Genentech | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Vemurafenib in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Vemurafenib and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Vemurafenib, including Zelboraf.
Yes. The US FDA first approved Vemurafenib on 17 August 2011, according to Drugs@FDA.
Yes. Vemurafenib has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Vemurafenib is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Vemurafenib is classified under ATC code L01EC01 (Vemurafenib).
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