Idarucizumab, a Humanized, Monoclonal Antibody Fragment for Immediate Reversal of Dabigatran

Abstract

Idarucizumab represents an encouraging development in the reversal of dabigatran. 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 (Praxbind) for reversal of pradaxa prior to emergent repair of contained ruptured transverse arch aneurysm

“…This is presumably to monitor for any reaction with the first dose since it is a monoclonal antibody and they may cause hypersensitivity reactions. The activity of the antibody complex is expected to last clinically up to 24 h.[ 6 ] The full dose was completed during preparation for general anesthesia, and the patient underwent right axillary cannulation, followed by median sternotomy with preparation for moderate hypothermic circulatory arrest. Heparinization was achieved with 30,000 units and adequate activated clotting time was assured to be >480 s. Standard two-stage venous drainage via the right atrium with combination of antegrade and retrograde cardioplegia was employed.…”

“…Idarucizumab binds dabigatran and its active metabolites to reverse its anticoagulant effects immediately and is useful for emergency surgery. [ 6 ] To the best of our knowledge, this is the first report of an emergent ruptured aneurysm repair and the use of idarucizumab before initiation of cardiopulmonary bypass. No abnormal sequelae were seen in the conduct of the operation or performance of extracorporeal perfusion.…”

“…Recent Food and Drug Administration approval of idarucizumab, a monoclonal antibody, which binds dabigatran to neutralize its effects, has become available. [ 5 6 7 ] Little is known about it effects in cardiothoracic surgical patients who present needing emergent surgery and currently taking dabigatran. We present a case of a 72-year-old man who was airlifted to our hospital for emergent repair of contained ruptured transverse arch aneurysm with constant chest pain and pressure.…”

The Reversal of Bleeding Caused by New Oral Anticoagulants (NOACs): A Systematic Review and Meta-Analysis

“…The FDA approval was based on preclinical studies in healthy volunteers and cohort studies, but good evidence of its efficacy is still limited. 20–25 Furthermore, idarucizumab is only specific to dabigatran, so the use of hemostatic agents is still crucial. Although there are specific antidotes for FXa inhibitors (ie, andexanet alfa and ciraparantag), clinical use and data are still limited because andexanet alfa has just recently been approved by the US FDA in May 2018, whereas ciraparantag is still waiting for the FDA approval.…”

Idarucizumab administration for reversing dabigatran effect in an acute kidney injured patient with bleeding

“…Dear Sirs, Dabigatran, is an oral direct thrombin inhibitor, approved worldwide for the prevention of stroke caused by non val-vular atrial fibrillation, and for the curative and preventive treatment of venous thromboembolism (1). Despite a higher occurrence of major bleedings with warfarin compared with dabigatran (2,3), dabigatran-related bleedings may require a specific fast acting antidote, i.e idarucizumab (Id) (4). Pharmacokinetic and pharmacodynamic profile of idarucizumab has been well studied in general population without kidney injury (5).…”