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>>

    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.

    Successfully Stashed! 💊

    This package insert has been safely stored in your digital medical cabinet. No prescription needed to view it later!

    View My Favourites
    WhatsApp Email LinkedIn