Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling +44 (0)1707 367554.
* 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-00004704
Date of preparation: September 2021
