FDA approves Kcentra for warfarin reversal in emergency surgery patients

FDA expanded the indication for Prothrombin Complex Concentrate [Human] (Kcentra, CSL Behring) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure.

Kcentra was approved by 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 United States for these uses. 

Three to 4 million adults in the United States are treated with warfarin each year 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. However, 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.

“When patients who are taking warfarin require an urgent surgery or other invasive procedure, it is critical to quickly reverse the coagulation factor deficiencies produced by warfarin to minimize the risk of a serious bleeding complication,” said Antoinette Mangione, MD, PharmD, Senior Director, North America Medical Affairs, CSL Behring.

“FDA approval of the expanded indication for Kcentra provides healthcare professionals with an important new intervention to prevent excessive bleeding in warfarin patients who need an urgent surgery or invasive procedure,” she told Formulary.

The most common adverse reactions (frequency ≥2.8%) observed in patients receiving Kcentra in both the Acute Major Bleeding Study and the Urgent Surgery/Invasive Procedure study were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events including stroke, pulmonary embolism, and deep vein thrombosis.