Evrysdi 0,75 mg/mL Powder for oral solution
PDF Leaflet Revision Date: 08 July 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Treatment of spinal muscular atrophy (SMA) Types 1, 2, and 3.
Dosage (summary)
Oral once daily; 0.15 mg/kg for <2 months, 0.20 mg/kg for 2 months to <2 years, 0.25 mg/kg for u22652 years (<20 kg), 5 mg for u22652 years (u226520 kg).
Special Populations
- Elderly
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Contraindicated in pregnancy and breastfeeding; embryo-foetal toxicity observed.
Key Drug Interactions
- CYP3A inhibitors
- FMO1 and FMO3 substrates
Contraindications
- Hypersensitivity to risdiplam
- Pregnancy
- Lack of effective contraception in reproductive potential individuals
Common side effects
- Diarrhoea
- Rash
- Nausea
- Mouth ulcers
- Headache
Counselling Points
- Take at the same time daily
- Use effective contraception
- Discuss preparation with HCP
Serious warnings
- Embryo-foetal toxicity
- Potential male fertility effects
Important Disclaimer
The Evrysdi 0,75 mg/mL Powder for oral solution professional information leaflet below is the property of Roche 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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