Its novel mechanism of action, pharmacokinetics, tolerability, and lack of thrombotic events contribute positively to its use in patients who experience bleeding or for those who require emergent surgery or procedures. Idarucizumab represents an encouraging development in the reversal of dabigatran. Idarucizumab represents an encouraging development in the reversal of dabigatran. Recent results from phase 3/4 studies demonstrate efficacy for an antidote to dabigatran (idarucizumab, a monoclonal antibody fragment with specificity for dabigatran) and an antidote to factor Xa inhibitors (andexanet alfa, a recombinant and inactive form of factor Xa that binds inhibitors). The United States Food and Drug Administration granted priority review for the biologic license application and accelerated approval for idarucizumab. Andexanet alfa is a biologic agent, a recombinant modified version of human activated factor X (FXa). Additionally, evaluations have shown that dabigatran can be safely reinitiated 24 hours after the administration of idarucizumab. Idarucizumab did not overcorrect thrombin generation. Studies evaluating reversal of dabigatran-induced anticoagulation have demonstrated immediate, complete, and sustained effects with idarucizumab. Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an IgG1 isotype molecule, whose target is the direct thrombin inhibitor dabigatran. Idarucizumab represents a novel treatment option as it is the only humanized, monoclonal antibody fragment that specifically binds to dabigatran. Studies evaluating the pharmacology, pharmacokinetics, safety, and efficacy of idarucizumab for the reversal of the anticoagulant activity of dabigatran were included. To evaluate the role of idarucizumab, a humanized monoclonal antibody fragment, as a specific reversal agent for the anticoagulant activity of dabigatran and to review the pharmacology, pharmacokinetic properties, efficacy, and safety of this agent.Ī literature search was conducted consisting of a PubMed database using the MeSH term idarucizumab and the key word dabigatran antidote.
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