Balfaxar Approved for Warfarin Reversal in Urgent Surgery, Invasive Procedures

The Food and Drug Administration (FDA) has approved Balfaxar^® (prothrombin complex concentrate, human-Ians) for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, eg, warfarin) therapy in adult patients with need for an urgent surgery or invasive procedures.

Balfaxar is a human plasma-derived, purified, virus inactivated and nanofiltered non-activated prothrombin complex concentrate containing the coagulation factors II, VII, IX, and X and antithrombotic proteins C and S. Balfaxar temporarily corrects the coagulation defect of patients with deficiency of 1 or several of these factors.

The approval was based on data from the randomized, double-blind, LEX-209 study (ClinicalTrials.gov Identifier: NCT02740335), which evaluated the efficacy and safety of Balfaxar in patients with acquired coagulation factor deficiency due to oral VKA therapy who needed urgent surgery. Patients were randomly assigned to receive a single dose of Balfaxar (n=105) or Kcentra (n=103). Baseline International Normalized Ratio (INR) was reported to be 3.96 and 3.56 in the Balfaxar and Kcentra arms, respectively.

Results showed that treatment with Balfaxar was noninferior to Kcentra. At the prespecified interim analysis, 94.6% of patients in the Balfaxar arm met the primary endpoint achieving effective hemostasis compared with 93.5% of those in the Kcentra arm (difference, 1.1% [98% CI, -9.2%, 11.5%]; P <.001). At the final analysis, effective hemostasis was demonstrated in 94.3% of the Balfaxar group and 94.2% of the Kcentra group, resulting in a difference of 0.1% (95% CI, -8.0%, 8.2%).

The proportion of patients achieving an INR 1.5 or less at 30 minutes after the end of the infusion (secondary endpoint) was 78.1% in the Balfaxar arm vs 71.8% in the Kcentra arm (proportion difference, 6.3%; 95% CI, -5.5%, 18.0%).

The most common adverse reactions reported in Balfaxar-treated patients were procedural pain, wound complications, asthenia, anemia, dysuria, procedural vomiting, and catheter site related reaction.

Balfaxar is supplied as a lyophilized powder for reconstitution in a single-dose vial with a nominal strength of 500 Factor IX units in 20 mL reconstitution volume and 1000 Factor IX units in 40 mL reconstitution volume per vial. Dosing should be individualized based on the patient’s baseline INR value and body weight.

This article originally appeared on MPR