"The FDA's approval of this new product gives physicians a choice when deciding how to treat patients requiring urgent reversal of vitamin K antagonist anti-coagulation," Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA, said in a statement. "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 vitamin K antagonist anti-coagulation."
Plasma is the only other product approved for this use in the United States, the FDA said.
Patients receiving chronic anti-coagulation therapy with warfarin and other vitamin K antagonist anti-coagulants to prevent blood clotting in conditions such as atrial fibrillation or the presence of an artificial heart valve sometimes develop acute bleeding.
Like plasma, Kcentra is used in conjunction with the administration of vitamin K to reverse the anti-coagulation effect and stop the bleeding. Unlike plasma, Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma, the FDA said.
Kcentra is associated with the occurrence of blood clots when used as indicated, and carries a boxed warning regarding the risk of blood clots.