binimetinib
Mektovi · ATC code L01EE03
- Key facts
- Active substance
- binimetinib
- ATC code
- L01EE03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Mektovi 15 mg film-coated tablets / Mektovi 45 mg film-coated tablets
- Marketing authorisation holder
- Pierre Fabre Medicament
- Information as of
- 2026-10-29
Key facts
Binimetinib (Mektovi) is a MEK inhibitor used together with encorafenib for BRAF V600-mutant unresectable or metastatic melanoma and BRAF V600E-mutant advanced non-small cell lung cancer in adults.
What it is used for
- In combination with encorafenib: adults with unresectable or metastatic melanoma with a BRAF V600 mutation.
- In combination with encorafenib: adults with advanced non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.
- The BRAF mutation must be confirmed by a validated test before treatment; not for BRAF wild-type tumours.
Dosing
- 45 mg twice daily approximately 12 hours apart (total daily dose 90 mg), always with encorafenib.
- For adverse reactions: reduce to 30 mg twice daily; doses below 30 mg twice daily are not recommended, and therapy is stopped if 30 mg twice daily is not tolerated. Re-escalation is not recommended after left ventricular dysfunction or Grade 4 toxicity.
- If binimetinib is interrupted, encorafenib is reduced to 300 mg once daily; if binimetinib is permanently stopped, encorafenib is stopped too.
- Mild hepatic impairment (Child-Pugh A): no adjustment; not recommended in moderate or severe hepatic impairment.
- No adjustment for patients aged 65 years and older. After vomiting, the dose is not repeated. See the full text for toxicity-specific dose tables.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Left ventricular dysfunction can occur; LVEF should be assessed before starting, 1 month after starting and then at approximately 3-month intervals.
- Ocular events such as retinal pigment epithelial detachment and retinal vein occlusion; retinal vein occlusion requires permanent discontinuation.
- Asymptomatic CK elevations and uncommonly rhabdomyolysis; CK and creatinine should be monitored monthly during the first 6 months.
- Venous thromboembolism (deep vein thrombosis, pulmonary embolism) may require interruption or discontinuation.
- Efficacy is lower after progression on a prior BRAF inhibitor; limited data in brain metastases.
Side effects
- Most common (> 25 %) with encorafenib: fatigue, nausea, diarrhoea, vomiting, abdominal pain, myopathy/muscular disorders and arthralgia.
- Very common: anaemia.
- Common: cutaneous squamous cell carcinoma, skin papilloma, hypersensitivity; uncommon: basal cell carcinoma.
- Retinal pigment epithelial detachment was mostly Grade 1.
Interactions
- UGT1A1 inducers (e.g. rifampicin, phenobarbital) and inhibitors (e.g. indinavir, atazanavir, sorafenib) should be used with caution.
- CYP1A2 inducers (e.g. carbamazepine, rifampicin) and P-gp inducers (e.g. St John's wort, phenytoin) may reduce binimetinib exposure and efficacy.
Pregnancy and breastfeeding
- Not recommended during pregnancy; women of childbearing potential must use effective contraception during treatment and for at least 1 month after the last dose.
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.
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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)
- MektoviPierre Fabre Medicament · EMEA/H/C/004579
Source: European Medicines Agency (EMA), product information
Turkey
- MektovıPIERRE 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
- Mektovi
- Liechtenstein
- Mektovi
- Norway
- Mektovi
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?
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Sources
- European Medicines Agency. Mektovi – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/mektovi-epar-product-information_en.pdf
- 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.