Fabrazyme 5 mg / 35 mg Powder for solution for infusion

Fabrazyme 5 mg / 35 mg Powder for solution for infusion

S4
PDF Leaflet Revision Date: 28 October 2022


Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of Fabry disease.

Dosage (summary)

1.0 mg/kg body weight IV every 2 weeks over 2 hours.

Special Populations

  • Renal insufficiency
  • Hepatic insufficiency
  • Elderly patients
  • Children younger than 8 years

Pregnancy & Breastfeeding

Not recommended during pregnancy; may be excreted in breast milk.

Key Drug Interactions

  • Chloroquine
  • Amiodarone
  • Benoquin
  • Gentamycin

Contraindications

  • Hypersensitivity to agalsidase beta or excipients

Common side effects

  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Anaphylaxis

Counselling Points

  • Monitor for infusion reactions
  • Consider home infusion if tolerated
  • Avoid during pregnancy and breastfeeding

Serious warnings

  • Infusion-associated reactions
  • Hypersensitivity reactions
Important Disclaimer

The Fabrazyme 5 mg / 35 mg Powder 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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