Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin-related bleeding.

BACKGROUND: Current reversal options for warfarin-related bleeding are limited but include fresh frozen plasma, recombinant factor VIIa, or a prothrombin complex concentrate (PCC). There are little data discussing the use of activated 4-factor PCC for warfarin reversal.

OBJECTIVES: This review will summarize our experiences with FEIBA (Baxter, Deerfield, IL), an activated 4-factor PCC, for the reversal of warfarin-related bleeding in a community hospital.

METHODS: A protocol was put in place in March of 2011, which outlined the use of FEIBA for the emergent reversal of warfarin-related coagulopathy. A low fixed dose was given based on international normalized ratio (INR). For an INR less than 5.0, 500 U of FEIBA was administered. For an INR greater than or equal to 5.0, 1000 U of FEIBA was given. Intravenous vitamin K was given concurrently regardless of INR.

RESULTS: Sixteen patients were treated with FEIBA per the protocol. Average patient age was 73 years. Intracranial hemorrhage was the most common indication for reversal. Mean pre-treatment INR was 3.56 (1.3-6.8); mean post-treatment INR was 1.16 (1.01-1.32). Two of the patients required a second 500-U dose, per the protocol, for an INR that had not yet normalized. Bleeding appeared clinically controlled in 93% of cases. Eighty-seven percent of patients survived to discharge. There were no signs or symptoms of thrombosis in any of the cases.

CONCLUSIONS: Emergent reversal of warfarin utilizing a fixed, low dose of FEIBA appears to be efficacious, consistent, and safe. Further comparator studies with other reversal agents are needed.