Myozyme 50 Mg 50 mg Powder for concentrate for solution for infusion
PDF Leaflet Revision Date: 13 August 2025
Clinical Summary
Quick overview from the medicine insert
Indication
Enzyme replacement therapy for Pompe disease.
Dosage (summary)
20 mg/kg IV every 2 weeks.
Special Populations
- Paediatric patients
- Elderly patients
- Renal impairment
- Hepatic impairment
Pregnancy & Breastfeeding
Limited data; consider risks vs benefits during pregnancy and lactation.
Contraindications
- Hypersensitivity to alglucosidase alfa or excipients
Common side effects
- Infusion-associated reactions
- Headache
- Nausea
- Dizziness
- Urticaria
Counselling Points
- Monitor for signs of hypersensitivity
- Administer under medical supervision
- Consider premedication for infusion reactions
Serious warnings
- Serious hypersensitivity reactions
- Anaphylactic reactions
- Monitor for infusion reactions
Important Disclaimer
The Myozyme 50 Mg 50 mg Powder for concentrate for solution for infusion professional information leaflet below is the property of Sanofi-Aventis South Africa 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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