The FDA announced the approval of Kcentra (prothrombin complex concentrate [human]; CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (eg, warfarin) therapy in adults with acute major bleeding. 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.
Currently, plasma is the only other FDA-approved product for this indication in the U.S. Like plasma, Kcentra is used with the administration of vitamin K to reverse the effect of anticoagulation. However, unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
The approval was based on a Phase 3b study evaluating patients (n=212) who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use. Kcentra met all efficacy and safety endpoints, including the endpoints of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma.
Kcentra is supplied as 500 units in a single-use vial for reconstitution. Each kit also includes sterile water for injection, a Mix2Vial filter transfer set, and alcohol swab.
For more information call (800) 504-5434 or visit the CSL Behring website.