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trametinib

Mekinist, Spexotras · ATC code L01EE01

Key facts
Active substance
trametinib
ATC code
L01EE01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Mekinist 0.5 mg film-coated tablets / Mekinist 2 mg film-coated tablets · Spexotras 0.05 mg/ml powder for oral solution
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Trametinib (Mekinist, Spexotras) is a MEK inhibitor used, mostly together with dabrafenib, to treat tumours with a BRAF V600 mutation.

What it is used for

  • Mekinist: unresectable or metastatic melanoma with a BRAF V600 mutation in adults and adolescents aged 12 years and older (alone or with dabrafenib); adjuvant treatment with dabrafenib of Stage III melanoma after complete resection.
  • Mekinist with dabrafenib: advanced non-small cell lung cancer with a BRAF V600 mutation; locally advanced or metastatic differentiated thyroid cancer with a BRAF V600E mutation, refractory to radioactive iodine, after prior systemic therapy.
  • Spexotras with dabrafenib: low-grade glioma or previously treated high-grade glioma with a BRAF V600E mutation in children aged 1 year and older.

Dosing

  • Mekinist, adults: 2 mg once daily regardless of body weight.
  • Mekinist, adolescents with melanoma: 1 mg (26 to 37 kg), 1.5 mg (38 to 50 kg) or 2 mg (51 kg or more) once daily; adjuvant treatment for 12 months.
  • Spexotras (powder for oral solution): weight-based once-daily dose, e.g. from 0.30 mg at 8 kg to 2 mg at ≥51 kg (see the full text).
  • Mekinist tablets are taken without food (at least 1 hour before or 2 hours after a meal); a missed dose is taken only if it is more than 12 hours until the next dose.
  • Dose reduction or interruption for adverse reactions; interrupt for temperature ≥38ºC. BRAF mutation must be confirmed beforehand.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • LVEF reduction and left ventricular dysfunction; cardiac function should be monitored.
  • Eye disorders such as retinal vein occlusion and retinal pigment epithelial detachment: visual disturbances need ophthalmological evaluation.
  • Interstitial lung disease/pneumonitis: withhold if suspected.
  • Pyrexia (more frequent with dabrafenib), haemorrhage, hypertension, rhabdomyolysis, colitis and gastrointestinal perforation.
  • With dabrafenib, new cutaneous and non-cutaneous malignancies; skin examination before starting and monthly.

Side effects

  • Mekinist monotherapy, most common (≥20%): rash, diarrhoea, fatigue, peripheral oedema, nausea and dermatitis acneiform.
  • With dabrafenib in adults, most common: pyrexia, fatigue, nausea, rash, chills, diarrhoea, headache, arthralgia, vomiting, cough, haemorrhage and peripheral oedema.
  • In children (with dabrafenib): pyrexia (70%), rash (49%), headache (47%), vomiting (40%).

Interactions

  • Caution with strong P-gp inhibitors (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole).
  • With dabrafenib, hormonal contraceptives may be less effective; a barrier method should be used.

Pregnancy and breastfeeding

  • Effective contraception during treatment and for 16 weeks after stopping; if used in pregnancy, the patient should be informed of the risk to the foetus.
  • Should not be given to breast-feeding mothers; a decision between stopping breast-feeding or trametinib is needed.

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)

  • MekinistNovartis Europharm Limited · EMEA/H/C/002643
  • SpexotrasNovartis Europharm Limited · EMEA/H/C/005886

Source: European Medicines Agency (EMA), product information

Turkey

  • MekinistNOVARTİS 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
Mekinist, Spexotras
Liechtenstein
Mekinist, Spexotras
Norway
Mekinist, Spexotras

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. Mekinist – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/mekinist-epar-product-information_en.pdf
  2. European Medicines Agency. Spexotras – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/spexotras-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.