Drug updated on 11/10/2023

Dosage FormInjection (intravenous; 2.5 g/50 mL)
Drug ClassHumanized monoclonal antibody fragment (Fab)
Ongoing and Completed


  • Indicated in patients treated with Pradaxa┬« when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.

Product Monograph / Prescribing Information

Document TitleYearSource
Praxbind (idarucizumab) Prescribing Information.2021FDA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Idarucizumab for dabigatran reversal: A systematic review and meta-analysis of indications and outcomes2023Thrombosis research
Dabigatran-reversal failure using standard dose of idarucizumab: a systematic review and meta-analysis of cases2023Research and practice in thrombosis and haemostasis
Management of perioperative bleeding risk in patients on antithrombotic medications undergoing cardiac surgery-a systematic review2022Journal of thoracic disease
Intravenous thrombolysis after dabigatran reversal by idarucizumab: a systematic review of the literature.2021Frontiers in Neurology
Use of direct-acting oral anticoagulants in solid organ transplantation: a systematic review.2021Pharmacotherapy
Meta-Analysis of Reversal Agents for Severe Bleeding Associated With Direct Oral Anticoagulants 2021Journal of the American College of Cardiology
Dabigatran Reversal With Idarucizumab and In-Hospital Mortality in Intracranial Hemorrhage: A Systematic Review of Real-Life Data From Case Reports and Case Series2021Frontiers in neurology
Incomplete responses to the recommended dose of idarucizumab: a systematic review and pharmacokinetic analysis.2020Clinical Toxicology
The incidence of thrombotic events with idarucizumab and andexanet alfa: A systematic review and meta-analysis2020Thrombosis research
Dabigatran reversal by idarucizumab in the setting of intracranial hemorrhage: a systematic review of the literature.2019Clinical Neurology and Neurosurgery
Intravenous thrombolysis in stroke after dabigatran reversal with idarucizumab: case series and systematic review2019Journal of neurology, neurosurgery, and psychiatry
The reversal of bleeding caused by new oral anticoagulants (NOACs): a systematic review and meta-analysis.2018Clinical and Applied Thrombosis/Hemostasis
Idarucizumab for reversing dabigatran-induced anticoagulation: a systematic review.2018American Journal of Therapeutics
Current evidence of oral anticoagulant reversal: A systematic review2018Thrombosis research
Anticoagulation reversal in vitamin K antagonist-associated intracerebral hemorrhage: a systematic review 2018Journal of thrombosis and thrombolysis

Clinical Practice Guidelines