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    HEMLIBRA

     

     

    For routine prophylaxis of bleeding episodes in patients of all ages with congenital haemophilia A, classified as severe or with Factor VIII (FVIII) inhibitors1

    • HEMLIBRA®▼ (emicizumab)
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    1. Roche Medicines
    2. Rare Diseases
    3. HEMLIBRA®▼ (emicizumab)
    4. Surgery
    HEMLIBRA

    126 patients on HEMLIBRA underwent surgery in the HAVEN studies2

    215 minor and 18 major surgeries were performed in patients receiving HEMLIBRA2

    Unplanned surgeries and elective minor procedures were allowed in the HAVEN study programme and were managed at the investigator’s discretion. No major or minor surgical procedure resulted in death, thrombosis, FVIII inhibitor development, or an unexpected bleed.2

    The safety and efficacy of HEMLIBRA have not been formally evaluated in the surgical setting.1

    126 patients with heamophilia A receiving HEMLIBRA had >1 surgical procedure

    126 patients receiving HEMLIBRA had at least one surgical procedure. HAVEN 1, n=38 of 113* adults and adolescents with inhibitors; HAVEN 2, n=27 of 88 paediatrics with inhibitors; HAVEN 3, n=45 of 152 adults and adolescents without inhibitors; HAVEN 4, n=16 of 48 adults and adolescents with and without inhibitors.2

    *One participant in HAVEN 1 discontinued prior to treatment.

    The surgery analysis includes more patients than the primary efficacy analyses, due to later data cut-offs of 2–11th October 2018.2,3 All data available at time of presentation are included here.

    Watch Professor Guy Young’s overview of surgical experience in the HAVEN study programme

    Related links:

    • Minor surgery
    • Major surgery
    • Efficacy
    • Study designs

    Surgeries were managed with HEMLIBRA alone or with HEMLIBRA and additional prophylaxis2

    Untitled Document

    215 minor surgeries were performed in 115 patients.2
    For more details on outcomes and how minor surgeries were managed please see Minor surgery

    18 major surgeries were performed in 18 patients.2
    For more details on outcomes and how major surgeries were managed please see Major surgery

    FVIII, Factor VIII.

    References:

    1. HEMLIBRA Summary of Product Characteristics.
    2. Santagostino E et al. ECTH 2019 [Oral Presentation].
    3. Oldenburg J et al. N Engl J Med 2017;377:809-18.

    M-GB-00001032

    Date of preparation: August 2020

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