Koselugo 10 Mg And 25 Mg 25 mg Hard Capsule
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
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