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vemurafenib

Zelboraf · ATC code L01EC01

Key facts
Active substance
vemurafenib
ATC code
L01EC01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Zelboraf 240 mg film-coated tablets.
Marketing authorisation holder
Roche Registration GmbH
Information as of
2026-10-28

Key facts

Vemurafenib (Zelboraf) is a BRAF kinase inhibitor used as monotherapy for adults with BRAF V600 mutation-positive unresectable or metastatic melanoma.

What it is used for

  • Monotherapy for adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma; the mutation must be confirmed by a validated test, and it should not be used in BRAF wild-type melanoma.

Dosing

  • 960 mg (4 tablets of 240 mg) twice daily (total daily dose 1,920 mg) until disease progression or unacceptable toxicity.
  • With or without food, but taking both daily doses consistently on an empty stomach should be avoided.
  • Missed dose: may be taken up to 4 hours before the next dose; never two doses together. No extra dose after vomiting.
  • For adverse events: reduce to 720 mg twice daily, then 480 mg twice daily; doses below 480 mg twice daily are not recommended. See the full text for the AE and QTc tables.
  • Treatment not recommended with QTc>500 ms at baseline.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Serious hypersensitivity reactions including anaphylaxis, and severe dermatologic reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS) require permanent discontinuation.
  • Exposure-dependent QT prolongation; QTc monitoring is needed.
  • Cutaneous squamous cell carcinoma can occur; dermatologic evaluation before starting and during treatment. Photosensitivity: sun protection (SPF ≥ 30) is advised.
  • Liver injury, including severe cases: liver enzymes and bilirubin before starting and monthly. Pancreatitis has been reported.
  • Radiation recall and sensitisation, some fatal; serious ophthalmologic reactions (uveitis, iritis, retinal vein occlusion).

Side effects

  • Most common (> 30%): arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea, diarrhoea, headache, pruritus, vomiting, skin papilloma and hyperkeratosis.
  • Most common Grade 3 (≥ 5%): cuSCC, keratoacanthoma, rash, arthralgia and GGT increased.

Interactions

  • Moderate CYP1A2 inhibitor: use with narrow-therapeutic-window CYP1A2 substrates (e.g. tizanidine, theophylline, duloxetine, agomelatine) is not recommended; caffeine exposure rose 2.6-fold.
  • CYP3A4 inducer; may decrease efficacy of hormonal contraceptives.
  • May increase exposure to P-gp substrates such as digoxin, dabigatran etexilate and aliskiren; caution with warfarin.

Pregnancy and breastfeeding

  • Should not be given in pregnancy unless the benefit outweighs the risk to the foetus; effective contraception during treatment and for at least 6 months after.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • ZelborafRoche Registration GmbH · EMEA/H/C/002409

Source: European Medicines Agency (EMA), product information

Turkey

  • ZelborafROCHE MÜSTAHZARLARI SAN.A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Zelboraf
Liechtenstein
Zelboraf
Norway
Zelboraf

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Other substances in the same group

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Zelboraf – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/zelboraf-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.