Concerns about idarucizumab for dabigatran reversal

Abstract

Management of bleeding in patients on nonvitamin-K antagonist oral anticoagulants (NOAC) is challenging because therapeutic options are few and their effectiveness is unpredictable [1,2]. Idarucizumab is an antibody fragment which binds both free and thrombin-bound dabigatran, and the idarucizumab-dabigatran complex is then cleared by the kidneys. Idarucizumab was developed by the manufacturer of dabigatran to reverse the anticoagulant effects of the NOAC dabigatran. The substance was tested in healthy male volunteers and showed immediate, complete and sustained reversal of dabigatran-induced anticoagulation, and was well tolerated [3].

Poor outcomes after dabigatran-associated intracranial hemorrhage despite idarucizumab reversal

“…Idarucizumab is a humanized monoclonal antibody fragment against dabigatran that produces rapid reversal of coagulation parameters. While Health Canada approved idarucizumab in March 2016 for severe dabigatran-associated bleeding, its impact on clinical outcomes remains imprecise due to the lack of high quality randomized studies and uncertainty regarding the therapeutic window for its administration [2]. The decision to administer idarucizumab in clinical practice is further complicated by the drug's high cost and perceived medicolegal risk to provider if withheld [3].…”