New Kcentra label includes urgent reversal of warfarin in an emergency surgery setting

CSL Behring today announced that Kcentra® (Prothrombin Complex Concentrate [Human]) has received U.S. Food and Drug Administration (FDA) approval for an expanded indication -- urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure. Kcentra, approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding, is the only non-activated 4-factor prothrombin complex concentrate (4F-PCC) indicated in the U.S. for these uses.

“When patients who are taking warfarin require an urgent surgical or invasive procedure, it is critical to quickly restore their coagulation status,” said Joshua N. Goldstein, M.D., Ph.D., Department of Emergency Medicine, Massachusetts General Hospital. “Kcentra is an important new option for such cases; it does not require blood-type matching or thawing, and restores clotting factors more quickly than plasma. We anticipate that emergency physicians, surgeons and other hospital clinicians will welcome the expanded indication.”

Kcentra helps restore blood coagulation by replenishing the levels of clotting factors that were depleted by warfarin therapy. Kcentra contains four vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as antithrombotic Proteins C and S.

Warfarin is used each year by approximately three to four million people in the U.S. to prevent blood clots from forming following a stroke, heart attack, heart valve surgery, deep vein thrombosis/pulmonary embolism, or certain types of irregular heartbeat, such as atrial fibrillation.[i],[ii] Due to the deficiency in blood clotting factors induced by warfarin treatment, patients are at increased risk of bleeding, especially if undergoing an urgent surgery or invasive procedure.

“At CSL Behring, we are committed to improving the lives of people with serious health conditions by continuously working to address unmet medical needs with novel therapies,” said Lynne Powell, Senior Vice President, North America Commercial Operations, CSL Behring. “The expanded indication for Kcentra in patients on warfarin therapy needing an urgent surgery or invasive procedure is another example of this commitment.”