Drug updated on 4/17/2024
| Dosage Form | Injection (intravenous; 2.5 g/50 mL) |
| Drug Class | Humanized monoclonal antibody fragments |
| 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
- Idarucizumab (Praxbind) is indicated for the reversal of the anticoagulant effects of dabigatran in patients requiring emergency surgery, urgent procedures or experiencing life-threatening bleeding.
- A total of 13 systematic reviews and meta-analyses were reviewed to gather information about idarucizumab (Praxbind).
- The drug has been found effective in achieving hemostasis, particularly during perioperative periods, with a low incidence rate of thromboembolic events post-administration.
- When compared to other reversal agents such as andexanet alfa and 4-factor prothrombin complex concentrates (4F-PCC), idarucizumab demonstrated superior effectiveness in achieving optimal perioperative hemostasis among specific patient groups undergoing cardiovascular surgery.
- Despite its efficacy, there remains a significant risk associated with adverse outcomes including mortality; one study reported a mortality rate of 17.7% among patients treated with various reversal agents including idarucizumab for severe DOAC-related bleeding.
- In acute ischemic stroke patients treated with dabigatran, administration of idarucizumab enabled safe thrombolysis indicating its potential role in managing stroke cases where anticoagulation needs to be reversed quickly.
- For solid organ transplant recipients on apixaban therapy - another direct oral anticoagulant - limited evidence was available regarding safety and effectiveness specifically related to use of idarucizumab necessitating individualized patient evaluations before prescribing this agent for these individuals.
- One concern raised by some studies is the potential rebound effect observed after administering Praxbind especially among those having reduced renal function or high baseline concentrations which underscores need for careful monitoring following treatment initiation along with possible dose adjustments based on kidney function status.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Praxbind (idarucizumab) Prescribing Information. | 2021 | FDA |