Koselugo 10 Mg And 25 Mg 25 mg Hard Capsule

Koselugo 10 Mg And 25 Mg 25 mg Hard Capsule

S4
PDF Leaflet Revision Date: 31 May 2023


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of symptomatic, inoperable plexiform neurofibromas in paediatric patients with NF1 aged 3 years and above.

Dosage (summary)

25 mg/mu00b2 BSA orally twice daily, individualized based on BSA.

Special Populations

  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Not recommended during pregnancy; breastfeeding should be discontinued during treatment.

Key Drug Interactions

  • CYP3A4 inhibitors
  • CYP2C19 inhibitors
  • Strong CYP3A4 inducers

Contraindications

  • Hypersensitivity to active substance
  • Severe hepatic impairment

Common side effects

  • Vomiting
  • Diarrhoea
  • Nausea
  • Dry skin
  • Rash

Counselling Points

  • Avoid pregnancy during treatment
  • Use effective contraception
  • Report visual disturbances

Serious warnings

  • Left ventricular ejection fraction reduction
  • Ocular toxicity
  • Liver laboratory abnormalities
Important Disclaimer

The Koselugo 10 Mg And 25 Mg 25 mg Hard Capsule professional information leaflet below is the property of Astrazeneca Pharmaceuticals and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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