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Direct Oral Thrombin Inhibitor — VTE / AF Stroke Prevention Pregnancy: Contraindicated — use LMWH instead

Dabigatran

Brand names: Pradaxa

Adult dose

Dose: VTE treatment: 150 mg BD after ≥5 days LMWH; VTE prophylaxis (orthopaedic): 75 mg then 220 mg OD; AF stroke prevention: 150 mg BD (or 110 mg BD if age ≥80 or interacting drugs)
Route: Oral
Frequency: Once or twice daily (indication-dependent)
Max: 300 mg/day (VTE treatment); 220 mg/day (prophylaxis/AF in elderly)
Requires parenteral anticoagulation for 5 days before initiation in acute VTE — unlike rivaroxaban/apixaban which can start immediately. Take with or without food — do NOT crush capsules (increases absorption by 75%). Antidote: idarucizumab (Praxbind) — specific licensed reversal agent.

Paediatric dose

Route:
Seek specialist opinion — weight and age-based dosing in paediatrics being investigated

Dose adjustments

Renal

Contraindicated if CrCl <30 mL/min (VTE treatment/AF); prophylaxis: CrCl <30 use with caution; check creatinine before every prescription — 80% renally cleared

Hepatic

Avoid in significant hepatic impairment

Clinical pearls

  • Idarucizumab (Praxbind) 5 g IV is the specific licensed reversal agent — fully reverses dabigatran within minutes; available in most UK hospitals
  • Dyspepsia affects ~10% — take with food or proton pump inhibitor if persistent; major cause of discontinuation
  • Highly renally dependent (80%) — renal function must be checked before initiating and annually (or every 6 months if CrCl 30–60)
  • Dabigatran levels measurable via dTT (dilute thrombin time) or ECT — useful in emergency/surgery context
  • RE-LY trial: 150 mg BD superior to warfarin for stroke prevention; 110 mg BD non-inferior with lower bleeding

Contraindications

  • CrCl <30 mL/min
  • Severe hepatic impairment
  • Active bleeding
  • Prosthetic heart valves
  • Concurrent P-gp inhibitors in renal impairment
  • Pregnancy

Side effects

  • Bleeding
  • Dyspepsia (very common — 10%)
  • GI upset
  • Nausea
  • Anaemia
  • Elevated LFTs (rare)

Interactions

  • P-gp inhibitors (amiodarone, verapamil, dronedarone, clarithromycin) — increase dabigatran levels — dose reduce
  • P-gp inducers (rifampicin, carbamazepine) — reduce levels — avoid combination
  • Amiodarone: reduce dabigatran to 110 mg BD
  • NSAIDs/antiplatelets — additive bleeding

Monitoring

  • Renal function at baseline and at least annually (every 6 months if CrCl 30–60 or age >75)
  • LFTs at baseline
  • FBC
  • Signs of bleeding
  • dTT/ECT if level measurement needed

Reference: BNFc; BNF 90; RE-LY Trial; RE-COVER Trial; NICE TA327 (Dabigatran for VTE); Idarucizumab REVERSE-AD Trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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