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encorafenib

Braftovi · ATC code L01EC03

Also known as: Enkorafenib

Key facts
Active substance
encorafenib
ATC code
L01EC03
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Braftovi 50 mg hard capsules / Braftovi 75 mg hard capsules
Marketing authorisation holder
Pierre Fabre Medicament
Information as of
2026-10-29

Key facts

Encorafenib (Braftovi, hard capsules) is an oral BRAF inhibitor. It is used in combination for melanoma, colorectal cancer and non-small cell lung cancer with a BRAF V600 mutation.

What it is used for

  • With binimetinib: unresectable or metastatic melanoma with a BRAF V600 mutation in adults.
  • With cetuximab: metastatic colorectal cancer with a BRAF V600E mutation after prior systemic therapy; with cetuximab and FOLFOX as first-line treatment.
  • With binimetinib: advanced non-small cell lung cancer with a BRAF V600E mutation.
  • The BRAF mutation must be confirmed with a validated test before starting; not for wild-type BRAF tumours.

Dosing

  • Melanoma and NSCLC (with binimetinib): 450 mg (six 75 mg capsules) once daily; reduction levels 300 mg and 225 mg once daily.
  • Colorectal cancer (with cetuximab, or with cetuximab and FOLFOX): 300 mg (four 75 mg capsules) once daily.
  • Mild hepatic impairment (Child-Pugh A): 300 mg once daily with caution; no recommendation in moderate or severe hepatic impairment.
  • Further dose modifications for adverse reactions: see the full text and the combination partners' product information.

Contraindications

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

Important warnings

  • Left ventricular dysfunction with binimetinib: assess LVEF before starting, after one month and then about every 3 months.
  • Haemorrhage, including major events; risk may be increased with anticoagulant and antiplatelet therapy.
  • Ocular toxicities (e.g. uveitis, iritis) can occur.
  • QTc prolongation: withhold if QTcF > 500 ms; permanently discontinue if also increased by >60 ms.
  • New primary cutaneous and non-cutaneous malignancies can occur.

Side effects

  • With binimetinib at 450 mg, most common (>25%): fatigue, nausea, diarrhoea, vomiting, abdominal pain, myopathy/muscular disorders and arthralgia.
  • Other serious reactions (haemorrhage, ocular, cardiac and skin reactions): see the full text.

Interactions

  • CYP3A4 inhibitors increase exposure (posaconazole about 3-fold in AUC); use with caution.
  • Strong CYP3A4 inducers (e.g. carbamazepine, rifampicin, phenytoin, St John's wort) may compromise efficacy; consider alternatives.
  • Encorafenib may decrease the efficacy of hormonal contraceptives.

Pregnancy and breastfeeding

  • No data in pregnant women; animal studies have shown reproductive toxicity.
  • Effective contraception during treatment and for at least 1 month after, with an additional barrier method if using hormonal contraception.

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)

  • BraftoviPierre Fabre Medicament · EMEA/H/C/004580

Source: European Medicines Agency (EMA), product information

Turkey

  • BraftoviPIERRE FABRE İLAÇ 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
Braftovi
Liechtenstein
Braftovi
Norway
Braftovi

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

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

Sources

  1. European Medicines Agency. Braftovi – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/braftovi-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 2026-10-29 · 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.