Khorsand N, Majeed A, Sarode R, Beyer-Westendorf J, Schulman S, Meijer K, Subcommittee on Control of Anticoagulation. Measurement and reversal of the direct oral anticoagulants. Idarucizumab for dabigatran reversal-full cohort analysis. Pollack CV Jr, Reilly PA, van Ryn J, Eikelboom JW, Glund S, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kam CW, Kamphuisen PW. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc 2018. PRAXBIND ® (idarucizumab) injection for intravenous use prescribing information. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. PRADAXA ® (dabigatran etexilate mesylate) for oral use. Idarucizumab represents an exciting new antidote for dabigatran, but clinical efficacy and cost-effectiveness data remain lacking. Real-world experience in a US hospital with the use of idarucizumab in emergency situations requiring the reversal of the effects of dabigatran is described. None of the patients experienced thrombotic complications or side effects that could be attributed to idarucizumab. One patient underwent open heart surgery and developed postoperative hemorrhage despite receiving idarucizumab. One patient with acute kidney injury needed two doses of the reversal agent to achieve hemostasis. Clinical hemostasis was achieved in 8 of 11 (72.7%) patients with major bleeding. Intracranial hemorrhage ( n = 6) and gastrointestinal bleed ( n = 2) were the most common types of bleeding. Idarucizumab was used in 11 patients for major bleeding events and in two patients for emergency surgery or procedures. In total, 13 patients received idarucizumab for atrial fibrillation during the study period. The course of treatment and clinical outcomes in patients who received idarucizumab for emergency surgery or procedures are described.
In patients with major bleeding, the efficacy of idarucizumab was assessed using criteria of the International Society of Thrombosis and Hemostasis Scientific and Standardization Subcommittee. Patients who received idarucizumab to reverse the effects of dabigatran between 1 January 2016 and 30 June 2018 were studied. The objective of this study was to describe clinical experience with idarucizumab in a large medical teaching center in the USA. Information on the use of idarucizumab in the clinical setting remains very limited. Idarucizumab is used to reverse the effects of dabigatran.
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