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)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Avoid grapefruit
Avoid grapefruit

Avoid grapefruit and grapefruit juice.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Cardiac risk / QT prolongation / arrhythmias
Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

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 latest medicines list: 01-02-2026
  • Product code: W71662001
  • Concentration: 5mg
  • Pharmaceutical form: granules packed in capsules to be opened
  • Quantity: 60
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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