The FDA approval of Praxbind was based on a single cohort case series trial with dabigatran-treated patients who had life-threatening or uncontrolled bleeding, or who required emergency surgery or urgent procedure (RE-VERSE AD). Side EffectsĪdverse effects associated with the use of Praxbind may include, but are not limited to, the following: It binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect. Praxbind (idarucizumab) is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. There is limited data to support administration of an additional 5 g of Praxbind. Praxbind is supplied as a solution for intravenous injection. The recommended dose of is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab. Praxbind is specifically indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures and /or in life-threatening or uncontrolled bleeding.

Praxbind fda approval