Leaflet KOSELUGO 5mg granules packed in capsules to be opened

Product code:
W71662001
Quantity:
60
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.

Official documents

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