Idarucizumab

(Praxbind®)

Idarucizumab

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Drug updated on 5/17/2024

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

Indication

  • 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.

Summary
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  • Idarucizumab (Praxbind) is effective in reversing the anticoagulant effects of dabigatran, with a reported hemostatic effectiveness rate of 77.7% and peri-procedural hemostasis achieved in 98.5% of patients.
  • Nine studies were reviewed to compare idarucizumab's safety and effectiveness against other anticoagulant reversal agents such as andexanet alfa or traditional therapies like vitamin K for warfarin or four-factor prothrombin complex concentrates (PCCs).
  • In cases of intracranial hemorrhage under anticoagulation, idarucizumab reduces the in-hospital mortality rate to between 9.7%-11.4%, demonstrating its potential use in critical care scenarios.
  • For acute ischemic stroke patients, idarucizumab facilitates safe and effective intravenous thrombolysis comparable to cases without any concerns about anticoagulation.
  • The safety profile of idarucizumab is favorable with low incidences post-reversal thromboembolic events at just 2%, suggesting a balanced risk-benefit profile even during emergency situations where it may be used for rapid reversal.
  • Special consideration should be given to its use in certain populations such as those with renal impairment due to possible rebounding dabigatran levels after administration. Careful dosing considerations are necessary, along with possibly additional doses depending on individual patient profiles including factors like renal function and potential drug-drug interactions.

Product Monograph / Prescribing Information

Document TitleYearSource
Praxbind (idarucizumab) Prescribing Information.2021Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines