* 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.
- Prophylaxis used
-
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.
- Prophylaxis used
-
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.
- Prophylaxis used
-
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.
- Prophylaxis used
-
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.
- Prophylaxis used
EHL, extended half-life; FVIII, Factor VIII; pdFVIII, plasma-derived FVIII; rFVIIa, recombinant activated Factor VII; rFVIII, recombinant FVIII.
References:
- HEMLIBRA Summary of Product Characteristics.
- Santagostino E et al. ECTH 2019 [Oral Presentation].
M-GB-00001033
Date of preparation: August 2020
