The U.S. Food and Drug Administration Monday approved Kcentra or Prothrombin Complex Concentrate, Human, for the urgent reversal of vitamin K antagonist or VKA anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States. However, the FDA said that Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
Patients who receive chronic anticoagulation therapy with warfarin and other VKA anticoagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve are sometimes prone to acute bleeding.
Commenting on the development, Karen Midthun, director, Center for Biologics Evaluation and Research, FDA, said, "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."
The FDA however said that Kcentra is associated with the occurrence of blood clots and carries a boxed warning regarding the risk of blood clots. The warning also explains that patients receiving Kcentra should be monitored for signs and symptoms of thromboembolic events, as both fatal and non-fatal arterial and venous thromboembolic complications have been reported in clinical trials and post marketing surveillance.
Kcentra, which has been made from the pooled plasma of healthy donors, is processed in a way as to minimize the risk of transmitting viral and other diseases, said the FDA in a statement. Approval of the compound was based on a study of 216 patients who had been receiving VKA anticoagulation and who had acute major bleeding along with a clotting test value indicative of anticoagulant use, it added.
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