Replagal 3,5 mg/ 3,5 ml Concentrate for solution for infusion

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.