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dabrafenib

Finlee, Tafinlar · ATC code L01EC02

Key facts
Active substance
dabrafenib
ATC code
L01EC02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Finlee 10 mg dispersible tablets · Tafinlar 50 mg hard capsules / Tafinlar 75 mg hard capsules
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Dabrafenib is an oral BRAF inhibitor (Tafinlar hard capsules, Finlee dispersible tablets). It is used alone or with trametinib for tumours with a BRAF V600 mutation.

What it is used for

  • Tafinlar: unresectable or metastatic BRAF V600 melanoma (adults and adolescents aged 12 years and older), alone or with trametinib; adjuvant treatment of Stage III melanoma after complete resection, with trametinib.
  • Tafinlar with trametinib: advanced BRAF V600 non-small cell lung cancer; locally advanced or metastatic BRAF V600E differentiated thyroid cancer refractory to radioactive iodine.
  • Finlee with trametinib: children aged 1 year and older with BRAF V600E low-grade glioma, or high-grade glioma after prior treatment.
  • The mutation must be confirmed with a validated test before starting.

Dosing

  • Tafinlar, adults: 150 mg (two 75 mg capsules) twice daily, regardless of body weight; 12 months in the adjuvant setting.
  • Tafinlar, adolescents with melanoma: 75 mg twice daily at 26 to 37 kg, 100 mg at 38 to 50 kg, 150 mg at 51 kg or more.
  • Finlee (children with glioma): twice-daily dose by body weight, from 20 mg (8 to 9 kg) to 150 mg (≥51 kg); Finlee must not be replaced with other dabrafenib formulations.
  • Take a missed dose only if it is more than 6 hours until the next dose.
  • Dose modifications for adverse reactions: see the full text and the trametinib SmPC.

Contraindications

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

Important warnings

  • Should not be used in wild-type BRAF tumours.
  • New malignancies (e.g. cutaneous squamous cell carcinoma, new primary melanoma) can occur; skin examination before starting, monthly, and for up to 6 months after treatment.
  • Pyrexia: interrupt therapy if temperature is ≥38°C.
  • Haemorrhage, including major and fatal events, with the trametinib combination.
  • Uveitis: withhold if it does not respond to local ocular therapy.

Side effects

  • Monotherapy (≥15%): hyperkeratosis, headache, pyrexia, arthralgia, fatigue, nausea, papilloma, alopecia, rash, vomiting.
  • With trametinib in adults (≥20%): pyrexia, fatigue, nausea, rash, chills, diarrhoea, headache, arthralgia, vomiting, cough, haemorrhage, peripheral oedema.
  • In children with trametinib, most common: pyrexia (70%), rash (49%), headache (47%), vomiting (40%).

Interactions

  • Use with caution with strong CYP2C8 or CYP3A4 inhibitors (e.g. ketoconazole, gemfibrozil, clarithromycin, ritonavir, itraconazole).
  • Avoid potent inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
  • Dabrafenib may decrease the efficacy of hormonal contraceptives.

Pregnancy and breastfeeding

  • Should not be given to pregnant women unless the benefit to the mother outweighs the possible risk to the foetus.
  • Effective non-hormonal contraception during therapy and for 2 weeks after dabrafenib and 16 weeks after trametinib.

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)

  • FinleeNovartis Europharm Limited · EMEA/H/C/005885
  • TafinlarNovartis Europharm Limited · EMEA/H/C/002604

Source: European Medicines Agency (EMA), product information

Turkey

  • TafinlarNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 4 register entries

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

Brand names in 3 more European countries
Iceland
Finlee, Tafinlar
Liechtenstein
Finlee, Tafinlar
Norway
Finlee, Tafinlar

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.

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Sources

  1. European Medicines Agency. Finlee – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/finlee-epar-product-information_en.pdf
  2. European Medicines Agency. Tafinlar – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tafinlar-epar-product-information_en.pdf
  3. 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.