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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
    5. Major Surgery
    HEMLIBRA

    18 major surgical procedures took place in 18 patients receiving HEMLIBRA2

    A total of three (16.7%) procedures were managed with HEMLIBRA alone and 15 (83.3%) were managed with HEMLIBRA and additional prophylaxis.2

    18 major surgical procedures took place in 18 patients receiving HEMLIBRA

    * Open reduction of fracture, muscle suture.

    † Removal of right femoral retained orthopaedic hardware, muscle suture, appendicectomy, epidural injection, cholecystectomy, incisional hernia repair, tonsillectomy.

    Management and outcomes of major procedures with additional prophylaxis2

    • Ankle arthroplasty²
      • Prophylaxis used
        • Standard rFVIII, pre-operative dose, 65.9 u/kg; cumulative dose post-procedure, 395.6 u/kg; 11 doses given in the first 7 days post-procedure, with 19 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Zero
      • No additional medication or anti-fibrinolytic therapy was used

      Please refer to the individual product Summary of Product Characteristics for further guidance on use.

    • Knee arthroplasty²
      • Prophylaxis used
        • rFVIIa, pre-operative dose, 357.7 µg/kg; cumulative dose post-procedure, 7,064.1 µg/kg; 52 doses given in the first 7 days post-procedure, with 29 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Zero
      • Anti-fibrinolytic therapy was used

      Please refer to the individual product Summary of Product Characteristics for further guidance on use.

    • Hip arthroplasty²

      Case one

      • Prophylaxis used
        • rFVIIa, pre-operative dose, 98.4 μg/kg; cumulative dose post-procedure, 3,688.5 μg/kg; 11 doses given in the first 7 days post-procedure, with 17 post-operative days on prophylaxis or treatment in total
        • pdFVIII, no pre-operative dose; cumulative dose post-procedure, 751.4 u/kg; 5 doses given in the first 7 days post-procedure, with 7 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Bleed due to surgery
      • Anti-fibrinolytic therapy was used
      • Additional medication, standard FVIII was used

      Case two

      • Prophylaxis used
        • rFVIIa: pre-operative dose, 89.7 μg/kg; cumulative dose post-procedure, 4,756.4 μg/kg; 33 doses given in the first 7 days post-procedure, with 23 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Zero
      • Anti-fibrinolytic therapy was used

      Case three

      • Prophylaxis used
        • Extended half-life (EHL) FVIII, pre-operative dose, 78.6 u/kg; cumulative dose post-procedure, 864.3 u/kg; 22 doses given in the first 7 days post-procedure, with 16 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Zero
      • No additional medication or anti-fibrinolytic therapy was used

      Please refer to the individual product Summary of Product Characteristics for further guidance on use.

    • Synovectomy²

      Case one

      • Prophylaxis used
        • Standard rFVIII, pre-operative dose, 55.0 u/kg; cumulative dose post-procedure, 192.6 u/kg; 4 doses given post-procedure, with 3 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Zero
      • No additional medication or anti-fibrinolytic therapy was used

      Case two

      • Prophylaxis used
        • Standard rFVIII, pre-operative dose, 106.7 u/kg; no further dose post-procedure
      • Post-operative bleeds
        • Zero
      • No additional medication or anti-fibrinolytic therapy was used

      Please refer to the individual product Summary of Product Characteristics for further guidance on use.

    • Arthrofibrosis, chondroplasty, joint debridement plus synovectomy²
      • Prophylaxis used
        • rFVIIa, pre-operative dose, 170.2 µg/kg; cumulative dose post-procedure, 4,087.8 µg/kg; 49 doses given post-procedure, with 15 post-operative days on prophylaxis or treatment in total
      • Post-operative bleeds
        • Bleed due to surgery
      • No additional medication or anti-fibrinolytic therapy was used

      Please refer to the individual product Summary of Product Characteristics for further guidance on use.

    EHL, extended half-life; FVIII, Factor VIII; pdFVIII, plasma-derived FVIII; rFVIIa, recombinant activated Factor VII; rFVIII, recombinant FVIII.

    References:

    1. HEMLIBRA Summary of Product Characteristics.
    2. Santagostino E et al. ECTH 2019 [Oral Presentation].

    M-GB-00001033

    Date of preparation: August 2020

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