Use of idarucizumab in reversing dabigatran anticoagulant effect: a critical appraisal

Marco Proietti,1–3 Giuseppe Boriani4 1Department of Neuroscience, IRCCS – Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy; 2Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK; 3Department of Internal Medicine and Medical Specialties, Sapienza-University of Rome, Rome, Italy; 4Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy Abstract: Use of non-vitamin K antagonist oral anticoagulants is spreading in the real world. Despite that, a strong need for antidotes/reversal agents is still reported by several physicians. Idarucizumab is a humanized monoclonal antibody fragment that binds specifically to dabigatran. Idarucizumab was approved in 2015 by the US Food and Drugs Administration and European Medicines Agency for reversal of anticoagulation activity in dabigatran-treated patients. This review briefly summarizes the experimental evidence about effectiveness and safety of idarucizumab. Furthermore, we review the current recommendations and experts’ point of view about the use of antidotes/reversal agents in patients reporting a major bleeding event. Keywords: anticoagulant drugs, non-vitamin K antagonist oral anticoagulants, reversal agents, idarucizumab, major bleeding