Kcentra Approved for Urgent Reversal of Warfarin in Emergency Surgery Setting

CSL Behring announced that the FDA has approved the expanded indication for Kcentra (Prothrombin Complex Concentrate [Human]) to include the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients needing an urgent surgery or other invasive procedure.

Kcentra is a non-activated 4-factor prothrombin complex concentrate containing vitamin K-dependent coagulation Factors II, VII, IX, and X, along with Protein C and Protein S. Kcentra is derived from the pooled plasma of healthy donors, and is processed in a way to minimize the risk of viral and disease transmission.

The approval for the expanded indication of Kcentra was based off a prospective, randomized, Phase 3b study which included 168 patients on Vitamin K antagonist therapy (eg, warfarin), who required urgent replacement of their Vitamin K-dependent clotting factors due to the need for an urgent surgery/invasive procedure. Kcentra was superior to plasma in achieving the endpoints of hemostatic efficacy for the time period from the start of infusion of Kcentra or plasma until the end of the urgent surgery or other invasive procedure (89.7% of patients treated with Kcentra vs. 75.3% treated with plasma) and INR reduction (to ≤1.3) at 30 minutes after the end of infusion (55.2% of patients treated with Kcentra vs. 9.9% of patients treated with plasma).

In April 2013, Kcentra was approved for the urgent reversal of warfarin therapy in adult patients with acute major bleeding.

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