MedeliX
Start asking

selumetinib

Koselugo · ATC code L01EE04

Key facts
Active substance
selumetinib
ATC code
L01EE04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Koselugo 10 mg hard capsules / Koselugo 25 mg hard capsules · Koselugo 5 mg granules in capsule for opening / Koselugo 7.5 mg granules in capsule for opening
Marketing authorisation holder
AstraZeneca AB
Information as of
2026-10-28

Key facts

Selumetinib (Koselugo) is an oral MEK inhibitor used to treat symptomatic, inoperable plexiform neurofibromas in neurofibromatosis type 1 (NF1).

What it is used for

  • Hard capsules (10 mg, 25 mg): monotherapy of symptomatic, inoperable plexiform neurofibromas in adults and children with NF1 aged 3 years and older.
  • Granules in capsule for opening (5 mg, 7.5 mg): the same condition in children aged 1 year to less than 7 years and older patients with swallowing difficulties.

Dosing

  • Hard capsules: 25 mg/m² body surface area twice daily (about every 12 hours), rounded to the nearest achievable 5 mg or 10 mg dose; maximum single dose 50 mg. Swallow capsules whole.
  • Granules: equivalent to 25 mg/m² twice daily, rounded to 2.5 mg, 5 mg or 10 mg; maximum single dose 50 mg.
  • For dose adjustments for adverse reactions, hepatic impairment and CYP3A4 or CYP2C19 inhibitors see the full text.

Contraindications

  • Hypersensitivity to the active substance or any excipient.
  • Severe hepatic impairment.

Important warnings

  • Left ventricular ejection fraction reduction (asymptomatic in 26% of children): echocardiogram before starting and at about 3-month intervals.
  • Ocular toxicity: blurred vision, subretinal fluid, retinopathy, RPED/CSR; new visual disturbances should be reported.
  • No supplemental vitamin E (capsules contain vitamin E); higher bleeding risk with anticoagulants or antiplatelets – monitor coagulation more often.
  • Risk of choking with capsules; rash and paronychia are common.

Side effects

  • Children (incidence ≥ 40%): vomiting (62%), acneiform rashes (60%), diarrhoea (56%), blood CPK increased (54%), nausea (52%), paronychia (50%), dry skin and pyrexia (44% each).
  • Adults (≥ 20%): acneiform rashes (55%), blood CPK increased (37%), diarrhoea (30%), non-acneiform rashes (27%) and vomiting (20%).
  • Others: stomatitis, hair changes, oedema, ejection fraction decrease.

Interactions

  • Itraconazole increased selumetinib AUC by 49% and fluconazole by 53%; strong CYP3A4 and CYP2C19 inhibitors raise levels.
  • Hormonal contraceptives may be less effective – add a barrier method.

Pregnancy and breastfeeding

  • Pregnancy test before starting; women and men use effective contraception during and for at least 1 week after treatment.

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 →

Common questions – ask Medelix

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)

  • KoselugoAstraZeneca AB · EMEA/H/C/005244

Source: European Medicines Agency (EMA), product information

Turkey

  • KoselugoALEXİON İLAÇ TİC. LTD. ŞTİ. · 2 register entries

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

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

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. Koselugo – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/koselugo-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.