BSN Tracker

dabigatran

Brand: Pradaxa

⚠ BBW ISMP High Alert Prototype Drug
Drug Class: anticoagulant
Drug Family: anticoagulant
Subclass: DOAC — direct thrombin inhibitor
Organ Systems: cardiovascularhematology-oncology

Mechanism of Action

Prodrug hydrolyzed by plasma esterases to active dabigatran; directly inhibits free and clot-bound thrombin; not metabolized by CYP450.

thrombin (IIa) active site

Indications

  • AF stroke prevention (non-valvular)
  • DVT/PE treatment
  • post-arthroplasty thromboprophylaxis

Contraindications

  • severe renal impairment (CrCl <30)
  • active major bleeding
  • mechanical prosthetic heart valves
  • moderate-severe mitral stenosis

Adverse Effects

Common

  • GI upset/dyspepsia (most common complaint)
  • bleeding

Serious

  • major hemorrhage
  • GI bleeding (highest of DOACs)

Pharmacokinetics (ADME)

Absorption 6.5% oral bioavailability
Distribution moderate
Metabolism prodrug hydrolysis by plasma esterases (NOT CYP)
Excretion renal 80-85%
Half-life 12-17 hours
Onset 2 hours
Peak 2-3 hours
Duration 12-24 hours
Protein Binding 35%
Vd 60-70 L

Drug Interactions

Drug / Agent Mechanism Severity
P-gp inhibitors (amiodarone, verapamil, dronedarone) increases dabigatran levels major
P-gp inducers (rifampin) decreases dabigatran levels — avoid major

Nursing Considerations

  1. Take with full glass of water to reduce GI irritation; may take with food
  2. Do NOT crush or open capsules
  3. Monitor CrCl at least annually; quarterly if CrCl 30-60
  4. Antidote: idarucizumab (Praxbind) 5 g IV for life-threatening bleeding
  5. Store in original container (moisture-sensitive)

Clinical Pearls

  • RE-LY trial: dabigatran 150 mg superior to warfarin for AF stroke prevention
  • Only DOAC with specific reversal agent (idarucizumab)
  • GI bleeding higher than warfarin despite lower intracranial bleeding

Safety Profile

Pregnancy avoid
Lactation avoid
Renal Adjustment Required
Hepatic Adjustment Not required
TDM Not required
Guideline Update pending

Concordance Terms

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

AF Stroke Prevention (non-valvular) Anticoagulant DVT/PE Treatment Post-arthroplasty Thromboprophylaxis
← Back to Medications