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Direct Oral Anticoagulant (Direct Thrombin Inhibitor) Pregnancy: D

Dabigatran Etexilate

Brand names: Pradaxa

Adult dose

Dose: 150 mg twice daily (VTE/AF treatment); 110 mg twice daily (age ≥80 or moderate renal/bleed risk)
Route: oral
Frequency: twice daily
Max: 300 mg/day
Store in original blister (hygroscopic — degrades if removed); do NOT crush; swallow with water

Paediatric dose

Route: oral
Frequency: twice daily
Max: Weight-based
Concentration: pellets for oral suspension mg/ml
Licensed ≥8 years for secondary VTE prevention; pellet formulation for children who cannot swallow capsules

Dose adjustments

Renal

110 mg BD if eGFR 30–50 ml/min; avoid if eGFR <30 ml/min

Hepatic

Avoid in severe hepatic impairment

Clinical pearls

  • Only DOAC with specific reversal agent idarucizumab (Praxbind) widely available for emergency reversal
  • Higher GI bleeding risk than warfarin — discuss with patients with GI risk factors
  • Renal elimination ~80% — most renally dependent DOAC; avoid with significant CKD

Contraindications

  • eGFR <30 ml/min
  • Severe hepatic impairment
  • Mechanical heart valves (RE-ALIGN trial — harm)
  • Prosthetic valves

Side effects

  • GI bleeding (highest of DOACs)
  • GI upset (dyspepsia, nausea)
  • Anaemia
  • Bleeding (all sites)

Interactions

  • P-gp inhibitors (dronedarone, rifampicin — contraindicated)
  • P-gp inhibitors (amiodarone, verapamil — increase levels)
  • Proton pump inhibitors (reduce levels 12–30%)

Monitoring

  • Renal function every 6–12 months (or with illness)
  • Signs of bleeding
  • FBC

Reference: BNFc; BNF 86; NICE TA249; RE-LY trial. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.