FDA Approves Therapy for Urgent Warfarin Reversal

The FDA approved Prothrombin Complex Concentrate (Kcentra), a first-in-class treatment for urgent vitamin K antagonist (VKA) anticoagulation reversal in adults with acute major bleeding. Kcentra is a product of CSL Behring. Kcentra is made from the blood of healthy donors and processed in a way to minimize the risk of transmitting viral and other diseases.

According to the FDA, the new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of VKA anticoagulation. Kcentra is administered in a significantly lower volume than plasma at recommended doses, providing an alternative for those patients who may not tolerate the volume of plasma required to reverse VKA anticoagulation.

Like plasma, Kcentra is used in conjunction with vitamin K to reverse the anticoagulation effect; unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.

In clinical trials, Kcentra met all efficacy and safety end points, including end points of hemostatic efficacy and International Normalized Ratio (INR) reduction compared with plasma.

Although Kcentra reverses the effects of warfarin, it does not work on the thrombin inhibitor dabigatran or any of the Factor Xa inhibitors, rivaroxaban or apixaban.

Kcentra carries a boxed warning regarding the risk of blood clots. Patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and nonfatal arterial and venous thromboembolic complications have been reported.