FDA Approves Balfaxar® for Reversal of Acquired Coagulation Factory Deficiency Induced by Vitamin K Antagonist in Adults
Octapharma USA has announced that Balfaxar® (prothrombin complex concentrate, human-lans; marketed in Europe and Canada as octaplex®) has received U.S. Food and Drug Administration approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
More than 2.4 million people in the United States use warfarin to keep their blood from clotting after a heart attack, stroke, or other serious thromboembolic complication. Balfaxar helps to restore blood coagulation by replenishing the levels of clotting factors that are deficient due to warfarin therapy.
Balfaxar is a non-activated four factor prothrombin complex concentrate (4F-PCC) containing vitamin K dependent factors: Factor II (prothrombin), Factor VII, Factor IX, and Factor X, as well as antithrombotic Proteins C and S.
The most common adverse reactions in those who received the candidate 4F-PCC (≥3%) being procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, and catheter site-related reaction.
