Section 13 · Monograph
Idarucizumab
Reviewed Nov 2026FDA label
PraxbindMonoclonal antibody fragment
- Forms
- IV: 2.5g/50mL vials (2 vials per dose)
- Dose
- 5g IV (two 2.5g vials) for dabigatran reversal
- MOA
- Binds dabigatran with high affinity, neutralizing it
Indications
- Reversal of dabigatran anticoagulant effects for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleedingFDA-labeled
Mechanism of Action
- Humanized monoclonal antibody fragment (Fab) that binds dabigatran and its metabolites with about 350-fold higher affinity than thrombin, neutralizing their effect
Full Dosing
Adult / usual
- 5g IV (two consecutive 2.5g/50mL vials) given as two infusions or bolus injections
- A second 5g dose may be considered for recurrent bleeding with elevated coagulation parameters or before a second urgent procedure
Contraindications
- None identified in labeling
Drug Interactions
- No known interactions; does not reverse other anticoagulants
Adverse Effects
- Headache
- Hypokalemia
- Delirium, constipation, fever (seen in older trials)
- Thromboembolic events following reversal of anticoagulation
- Hypersensitivity; sorbitol excipient is a concern in hereditary fructose intolerance
Monitoring Parameters
- Thromboembolic events — restart anticoagulation as soon as medically appropriate
- Coagulation tests (aPTT, dilute thrombin time, ECT) to assess reversal
- Hemodynamics
Pregnancy & Lactation
- Limited data; use if benefit outweighs risk