Safety evaluated in the largest clinical trial program of hemophilia A patients with and without FVIII inhibitors 

Pooled safety comparison included 391 patients 

  • The pooled safety analysis also included patients with and without FVIII inhibitors from the HEMLIBRA dose-finding study (n=18)

Cases of TMA and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of aPCC was administered for 24 hours or more to patients receiving HEMLIBRA® prophylaxis

Known safety profile established across multiple clinical trials

  • The most common adverse reactions (≥10%) were injection site reactions, arthralgia, and headache

Concomitant use of FVIII with HEMLIBRA prophylaxis was common in HEMLIBRA clinical trials

  • The number of co-exposure events was limited by the duration of the HAVEN 3 and HAVEN 4 studies (24 weeks)
  • Analysis includes subjects receiving FVIII at any point after 7 days of HEMLIBRA exposure. In HAVEN 3 and HAVEN 4, patients were allowed to continue on FVIII prophylaxis during the first week of HEMLIBRA prophylaxis
  • A FVIII treatment event starts with the first FVIII treatment and includes all infusions until a 36-hour break

aPCC=activated prothrombin complex concentrate; FVIII=factor VIII; TMA=thrombotic microangiopathy.

Updated Prescribing Information

Now includes information for patients without FVIII inhibitors

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