idarucizumab

Brand: Praxbind

Prototype Drug
Drug Class: anticoagulant reversal agent
Drug Family: reversal agent
Subclass: humanized monoclonal Fab fragment (dabigatran-specific antidote)
Organ Systems: cardiovascularhematology-oncology

Mechanism of Action

Humanized Fab fragment with 350x higher affinity for dabigatran than thrombin; rapidly neutralizes dabigatran and its acylglucuronide metabolites.

dabigatran and its metabolites

Indications

  • reversal of dabigatran anticoagulation for life-threatening bleeding or emergency surgery

Contraindications

  • no absolute contraindications

Adverse Effects

Common

  • hypersensitivity reactions
  • hypocoagulable state

Serious

  • thromboembolic events (rebound after reversal)

Pharmacokinetics (ADME)

Absorption IV only
Distribution intravascular
Metabolism proteolysis
Excretion renal
Half-life ~47 minutes
Onset immediate IV
Peak immediate
Duration hours
Protein Binding <0%
Vd 0.07 L/kg

Drug Interactions

Drug / Agent Mechanism Severity
dabigatran specific reversal beneficial

Nursing Considerations

  1. Dose: 2.5 g IV x2 given consecutively (two separate vials) = 5 g total
  2. Takes effect within minutes
  3. Monitor coagulation parameters (TT, eCT, aPTT) for reversal confirmation
  4. Can restart dabigatran 24 hours after idarucizumab if clinically appropriate
  5. Monitor for hypersensitivity

Clinical Pearls

  • REVERSE-AD: complete dabigatran reversal in >98% within 4 hours; median reversal immediate
  • Dabigatran can be restarted 24 hours after reversal when thrombosis risk resumes

Safety Profile

Pregnancy insufficient-data
Lactation insufficient-data
Renal Adjustment Required
Hepatic Adjustment Not required
TDM Not required

Concordance Terms

Cross-referenced clinical concepts — click any term to see all content where it appears.