Replagal 3,5 mg/ 3,5 ml Concentrate for solution for infusion
PDF Leaflet Revision Date: 24 July 2024
Clinical Summary
Quick overview from the medicine insert
Indication
Long-term enzyme replacement therapy for Fabry disease.
Dosage (summary)
0.2 mg/kg body weight every other week by IV infusion over 40 minutes.
Special Populations
- Elderly (65+ years)
- Hepatic impairment
- Renal impairment
Pregnancy & Breastfeeding
Limited data show no adverse effects in pregnancy; caution advised during breastfeeding.
Key Drug Interactions
- Chloroquine
- Amiodarone
- Gentamicin
Contraindications
- Hypersensitivity to agalsidase alfa or excipients
Common side effects
- Headache
- Nausea
- Fatigue
- Rigors
- Flushing
Counselling Points
- Monitor for infusion-related reactions.
- Record product name and batch number for traceability.
- Consider pre-treatment with antihistamines or corticosteroids.
Serious warnings
- Idiosyncratic infusion-related reactions
- Severe allergic reactions
Important Disclaimer
The Replagal 3,5 mg/ 3,5 ml Concentrate for solution for infusion professional information leaflet below is the property of Takeda 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>>
Healthcare Professionals Only
This content is for registered healthcare professionals
Sign in or create a free account to read the full package insert.
Free for HPCSA-registered professionals. Powered by Medinsert.
