Drug updated on 12/11/2024
| Dosage Form | Injection (intravenous; 2.5 g/50 mL) |
| Drug Class | Humanized monoclonal antibody fragments (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.
Latest News
Summary
- This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
- Among patients receiving intravenous thrombolysis (IVT) with recent direct oral anticoagulant (DOAC) use, 57% achieved functional independence at 90 days (95% confidence interval (CI), 43-70), similar to non-DOAC groups, which had a 56.8% functional independence rate (odds ratio (OR) 1.21, 95% CI, 0.40-3.67), indicating comparable effectiveness.
- Idarucizumab demonstrated a 77.7% hemostatic effectiveness (95% CI, 66.7-87.2%) across patients, with normal peri-procedural hemostasis observed in 98.5% (95% CI, 86.6-100%) of cases, highlighting high efficacy for dabigatran reversal in perioperative settings.
- In patients with high baseline dabigatran concentrations (>500 ng/mL) or significant renal impairment (glomerular filtration rate (GFR) <30 mL/min), idarucizumab showed effective dabigatran reversal but required close monitoring due to potential rebound, necessitating additional doses in some cases.
- In patients receiving IVT while on recent DOAC therapy, the rate of symptomatic intracranial hemorrhage (SICH) was 3% (95% CI, 3-4), and any intracranial hemorrhage (ICH) was 12% (95% CI, 7-19). Rates were comparable to non-DOAC groups for SICH (3.4% vs. 3.5%, OR 0.95, 95% CI, 0.67-1.36) and any ICH (17.7% vs. 17.3%, OR 1.23, 95% CI, 0.61-2.48), with no significant increase in systemic bleeding (0.7% vs. 0.6%, OR 1.27, 95% CI, 0.79-2.02).
- For patients administered idarucizumab, all-cause mortality was 13.6% (95% CI, 9.6-17.9%), and thromboembolic events occurred in 2.0% (95% CI, 0.8-3.4%). Dabigatran rebound was noted in 33 of 240 cases, with 10 cases requiring additional idarucizumab doses, highlighting the need for ongoing monitoring, particularly in patients with renal impairment.
- In patients with renal dysfunction, especially those with GFR <30 mL/min or high baseline dabigatran concentrations, there was a higher likelihood of dabigatran rebound post-idarucizumab administration, necessitating careful monitoring and possible repeat dosing.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Praxbind (idarucizumab) Prescribing Information. | 2021 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Intravenous Thrombolysis for Acute Ischemic Stroke in Patients With Recent Direct Oral Anticoagulant Use: A Systematic Review and Meta-Analysis | 2023 | Journal of the American Heart Association |
| Optimal management of cardiac surgery patients using direct oral anticoagulants: recommendations for clinical practice | 2023 | European Journal of Cardio-Thoracic Surgery |
| Idarucizumab for dabigatran reversal: A systematic review and meta-analysis of indications and outcomes | 2023 | Thrombosis Research |
| Incomplete responses to the recommended dose of idarucizumab: a systematic review and pharmacokinetic analysis | 2020 | Clinical Toxicology |