Retrospective review of BPA use during minor surgeries and procedures in HEMLIBRA clinical studies for FVIII inhibitor patients 17*

  • Analysis of the use of additional BPAs for minor surgeries or procedures was not an objective of the 2 pivotal studies, and there is limited experience from the clinical trials

Management of perioperative BPA was determined based on the investigator’s discretion

  • 29 surgeries were conducted in 22 patients; 20 out of 29 were managed without prophylactic BPAs
  • 6 surgeries resulted in post-operative bleeds, with 2 requiring treatment with on-demand BPAs

BPAs=bypassing agents; FVIII=factor VIII.

*Surgeries included 1 right knee arthroscopy, synovectomy, debridement of arthrofibrosis, and chondroplasty; 1 laparoscopic appendectomy; 9 central venous access device-related procedures; 6 tooth extractions; and 12 other minor surgical procedures. 
Monitoring includes D-dimer, prothrombin fragment F1+2 (if available), platelet count, serum creatinine, LDH, and peripheral blood smear analysis for schistocytes. For patients who require multiple BPA doses, laboratory monitoring should be performed every 24-48 hours thereafter until 24-48 hours following the last BPA dose administered to treat a given bleed. 1

 

National Broadcast

Register to learn more about the expanded indication of HEMLIBRA airing on Thursday, October 18, 2018.
Use one of the codes below:
7:00pm ET: PRF87072-P
9:00pm ET: PRF87073-P

Treating Breakthrough Bleeds

Guidelines for addressing breakthrough bleeds

Laboratory Monitoring Information

Considerations for using laboratory tests to monitor patients taking HEMLIBRA