FDA Okays Kcentra to Reverse Anticoagulation, Stop Bleeding

April 29, 2013

The US Food and Drug Administration (FDA) today approved a plasma-derived product for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding, the agency announced.

The new therapy, prothrombin complex concentrate, human (Kcentra, CSL Behring), addresses the problem of acute bleeding sometimes experienced by patients with atrial fibrillation or an artificial heart valve who receive long-term anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting.

Prothrombin complex concentrate, human, can be used more quickly than plasma to reverse the effect of VKA anticoagulants. Unlike plasma, it does not require blood group typing or thawing. In addition, it is administered in a far lower volume than plasma at recommended doses, good news for patients who may not tolerate the amount of plasma needed to stop the bleeding, said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research.

"The FDA's approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation," said Dr. Midthun.

As with plasma, prothrombin complex concentrate, human, is given together with vitamin K.

The FDA based its approval on a study of 216 individuals receiving VKA anticoagulation. The study showed that the new therapy resembled plasma in its ability to stop acute major bleeding.

A boxed warning on the label states that there is a risk for blood clots. Clinicians should monitor patients receiving the product for signs and symptoms of thromboembolic events.

Derived from the pooled plasma of healthy donors, prothrombin complex concentrate, human, is processed to minimize the risk of transmitting viral and other diseases, the FDA stated.

More information on today's FDA decision is available on the agency's Web site.