Leaflet KOSELUGO 5mg granules packed in capsules to be opened


Indicated for: cancer

Route of administration: oral

Substance: selumetinib (tyrosine kinase inhibitor)

ATC: L01EE04 (Antineoplastic and immunomodulating agents | Protein kinase inhibitors | Mitogen-activated protein kinase (MEK) inhibitors)

Selumetinib is a medication used for the treatment of neurofibromatosis type 1 (NF1) in pediatric patients with symptomatic plexiform neurofibromas. It acts as an inhibitor of MEK1 and MEK2 kinases, reducing tumor growth and associated symptoms.

The medication is taken orally, as directed by a doctor, usually twice daily. It is important for patients to follow the treatment regimen and undergo regular check-ups to monitor the response to therapy.

Patients should be aware of potential side effects, such as nausea, diarrhea, or elevated liver enzyme levels. It is important to inform the doctor of any unusual symptoms.

Common side effects include nausea, diarrhea, and elevated liver enzyme levels. In rare cases, severe reactions such as liver failure or allergic reactions may occur. Patients should be informed of these risks before starting treatment.

General data about KOSELUGO 5mg

  • Substance: selumetinib
  • Date of last drug list: 01-02-2026
  • Commercial code: W71662001
  • Concentration: 5mg
  • Pharmaceutical form: granules packed in capsules to be opened
  • Quantity: 60
  • Product type: original
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: ASTRAZENECA AB - SUEDIA
  • Holder: ASTRAZENECA AB - SUEDIA
  • Number: 1552/2021/03
  • Shelf life: 2 years

Pharmaceutical forms available for selumetinib

Concentrations available for selumetinib

  • 10mg
  • 25mg
  • 5mg
  • 7.5mg