Idarucizumab
PRAXBIND
What it isDabigatran-sequestering monoclonal antibody fragment; emergency reversal for life-threatening bleeding or urgent procedures.
Why this oneIt neutralizes dabigatran rapidly and specifically without directly activating coagulation.
What limits itIt reverses no other anticoagulant; thrombosis risk returns immediately, and redistribution can cause recurrent anticoagulation.
FDA label
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| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Reversal of dabigatran (emergency surgery/urgent procedure or life-threatening/uncontrolled bleeding) | Adults | 5 g IV once (two 2.5 g/50 mL vials) | 5 g IV once | additional 5 g may be considered (limited data) |
Renal Undefined
Hepatic Undefined
Limited data support an additional 5 g dose; safety/effectiveness of repeat treatment not established
Instructions
- IV only; give as two consecutive infusions or as bolus (inject both vials consecutively via syringe)
- Flush pre-existing line with 0.9% NaCl before infusion; no other infusion in parallel via same access
- Once removed from vial, begin promptly and use within 6 hours
- Dabigatran (Pradaxa) may be reinitiated 24 h after administration
Cautions
- Thromboembolic risk — reversing dabigatran exposes underlying thrombotic risk; resume anticoagulation as soon as appropriate
- Re-elevation of coagulation parameters 12–24 h after dose
- Hypersensitivity reactions
- Hereditary fructose intolerance — contains 4 g sorbitol
Adverse reactions
- Headache (healthy volunteers)
- Constipation
- Nausea
Pregnancy No available human data; give only if clearly needed
Lactation Unknown if excreted in human milk; exercise caution
NO BOXED WARNINGS
Principal riskThrombotic risk returns once reversed
Classes and tags
Clinical profile
Mechanism of action: Idarucizumab ballicule
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