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 17

  • 29 surgeries were conducted in 22 patients; 69% (20/29) were managed without prophylactic BPAs

BPAs=bypassing agents; rFVIIa=activated recombinant factor VII.
*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.
Three surgeries resulting in post-operative bleeding were treated with rFVIIa.
Eight surgeries were treated with rFVIIa and 1 surgery used a single dose of prophylactic aPCC. 

HAVEN 3 and HAVEN 4 surgical experience 

Retrospective review of patients undergoing surgeries and procedures in HAVEN 3

  • Analysis of the use of FVIII for surgeries or procedures was not an objective of the pivotal study, and there is limited experience from the clinical trial 2
  • In the HAVEN 3 trial, 28 patients underwent 46 minor procedures and 4 major procedures. No unexpected bleeding or complication was related to any procedure 2

Treating Breakthrough Bleeds

Guidelines for addressing breakthrough bleeds

Laboratory Monitoring Information

Considerations for using laboratory tests to monitor patients taking HEMLIBRA