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Anticoagulant Reversal — Dabigatran Pregnancy: Limited data — use only if benefits outweigh risks in life-threatening bleeding; consult haematology

Idarucizumab

Brand names: Praxbind

Adult dose

Dose: 5 g (two 2.5 g vials, each over 5–10 min)
Route: IV bolus or infusion
Frequency: Single dose (may repeat once within 24 hours if clinically indicated)
Max: 5 g (single dose)
Specific reversal agent for dabigatran. For emergency surgery, life-threatening bleeding, or overdose. Neutralises dabigatran within minutes. Restart anticoagulation as soon as haemostatically safe (minimum 24 hours).

Paediatric dose

Dose: Seek specialist opinion g/kg
Route: IV
Frequency: Single dose
Max: Not established in paediatric patients
Not licensed in children — seek specialist opinion from paediatric haematology

Dose adjustments

Renal

No dose adjustment required; dabigatran accumulates in renal impairment — idarucizumab may be especially indicated

Hepatic

No dose adjustment required

Paediatric weight-based calculator

Not licensed in children — seek specialist opinion from paediatric haematology

Clinical pearls

  • Binds dabigatran with 350× greater affinity than thrombin — essentially complete reversal within minutes
  • RE-VERSE AD trial: idarucizumab achieved full reversal in 98-100% of patients within 4 hours; median time to cessation of bleeding 11.4 hours
  • Sorbitol excipient — CONTRAINDICATED in hereditary fructose intolerance
  • After reversal, dabigatran plasma levels may rise again if residual dabigatran in tissue re-equilibrates — monitor coagulation
  • Check dTT (dilute thrombin time) or ECT (ecarin clotting time) to confirm reversal — aPTT and TT are less sensitive
  • For patients with dabigatran on DOAC who need urgent cardiac/vascular surgery — idarucizumab is the preferred approach over 4-factor PCC
  • Haemodialysis can remove dabigatran if idarucizumab unavailable — not applicable for other DOACs

Contraindications

  • Hypersensitivity to idarucizumab
  • Hereditary fructose intolerance (contains sorbitol)

Side effects

  • Hypersensitivity reactions (rare)
  • Constipation
  • Headache
  • Hypokalaemia
  • Fever
  • Delirium (in elderly — underlying disease)

Interactions

  • No clinically relevant drug interactions identified

Monitoring

  • dTT or ECT (confirmation of reversal)
  • Clinical haemostasis assessment
  • Renal function

Reference: BNFc; BNF 90; Pollack et al. RE-VERSE AD (NEJM 2017); SPC Praxbind; NICE guidance. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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