Hemlibra 30 mg/1 mL. 60 mg/0.4 mL. 105 mg/0.7 mL. 150 mg/1 mL Solution for injection

    Hemlibra 30 mg/1 mL. 60 mg/0.4 mL. 105 mg/0.7 mL. 150 mg/1 mL Solution for injection

    S4
    PDF Leaflet Revision Date: 30 October 2025

    API: Emicizumab | Company: Roche Products

    Clinical Summary

    Quick overview from the medicine insert

    Indication

    Routine prophylaxis to prevent bleeding in haemophilia A patients.

    Dosage (summary)

    Loading dose: 3 mg/kg weekly for 4 weeks; Maintenance: 1.5 mg/kg weekly, 3 mg/kg biweekly, or 6 mg/kg every four weeks.

    Special Populations

    • Paediatric patients
    • Elderly patients
    • Renal impairment
    • Hepatic impairment

    Pregnancy & Breastfeeding

    Not recommended during pregnancy or breastfeeding.

    Key Drug Interactions

    • Activated prothrombin complex concentrate (aPCC)
    • Recombinant factor VIIa (rFVIIa)

    Contraindications

    • Hypersensitivity to emicizumab or excipients

    Common side effects

    • Injection site reactions
    • Headache
    • Pyrexia
    • Arthralgia
    • Myalgia

    Counselling Points

    • Monitor for signs of thrombotic events
    • Do not use aPCC unless necessary
    • Proper injection technique is crucial

    Serious warnings

    • Thrombotic microangiopathy
    • Thromboembolism
    Important Disclaimer

    The Hemlibra 30 mg/1 mL. 60 mg/0.4 mL. 105 mg/0.7 mL. 150 mg/1 mL Solution for injection professional information leaflet below is the property of Roche Products 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