News | December 17, 2013

FDA Approves Kcentra Use in Warfarin Reversal for Patients Undergoing Surgery

New Kcentra Label Includes Urgent Reversal of Warfarin in Emergency Surgery Settings

December 17, 2013 — CSL Behring 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) (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 four-factor prothrombin complex concentrate (4F-PCC) indicated in the United States for these uses.
"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,” said Joshua Goldstein, M.D., Ph.D., Department of Emergency Medicine, Massachusetts General Hospital. “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 United States 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 (AF). 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.
About the Urgent Surgery/Invasive Procedure Clinical Trial
The prospective, randomized, Phase IIIb study used as the basis for the FDA approval of the expanded indication for Kcentra included 168 evaluable patients on Vitamin K antagonist therapy (warfarin) who required urgent replacement of their Vitamin K-dependent clotting factors due to the need for an urgent surgery/invasive procedure. Kcentra was superior to plasma in achieving the endpoints of hemostatic efficacy for the time period from the start of infusion of Kcentra or plasma until the end of the urgent surgery or other invasive procedure (89.7 percent of patients treated with Kcentra versus 75.3 percent treated with plasma) and international normalized ratio (INR) reduction (to less than or equal to 1.3) at 30 minutes after the end of infusion (55.2 percent of patients treated with Kcentra versus 9.9 percent of patients treated with plasma).
The secondary endpoints included plasma levels of major clotting factors (Factors II, VII, IX, X, antithrombotic proteins C and S) and safety and tolerability (including all-cause mortality). A single Kcentra infusion produced a rapid and sustained increase in plasma levels of clotting Factors II, VII, IX, and X within 30 minutes after the end of infusion with 89 percent less volume (90 mL +/- 32 mL versus 819 mL +/- 231 mL) than plasma. Additionally, infusion time with Kcentra was nearly seven times faster than with plasma (21 minutes versus 141 minutes for plasma).
Kcentra had a safety profile comparable to plasma. The most common adverse reactions (frequency greater than or equal to 2.8 percent) 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.
The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.
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