Dosage and administration

Nonvalvular atrial fibrillation

CrCl Dose
>30 mL/min 150 mg PO BID
≥15 to <30 mL/min 75 mg PO BID
<15 mL/min or dialysis Not recommended

DVT and PE

CrCl Dose
>30 mL/min 150 mg PO BID
≤30 mL/min or dialysis Not recommended

Start after 5-10 days of parenteral anticoagulation.

Reduction in risk of recurrence of DVT and PE in patients who have been previously treated

CrCl Dose
>30 mL/min 150 mg PO BID
≤30 mL/min or dialysis Not recommended

Dosing modifications (atrial fibrillation)

  • CrCl 30-50 mL/min and coadministration of P-gp inhibitors dronedarone or ketoconazole: Consider reducing dose to 75 mg BID. Dose adjustment not necessary when coadministered with other P-gp inhibitors
  • CrCl <30 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration.

Dosing modifications (DVT/PE)

  • CrCl <50 mL/min with concomitant use of P-gp inhibitors: Avoid coadministration.

Dosage forms and strengths

  • Capsules
    • 75 mg
    • 150 mg

Contraindications

  • Active pathological bleeding
  • History of serious hypersensitivity reaction to dabigatran
  • Mechanical prosthetic heart valve

Warnings and precautions

  • Bleeding: Can cause serious and fatal bleeding.
  • Bioprosthetic heart valves: Use is not recommended.

Adverse reactions

  • Most common adverse reactions (>15%) are gastritis-like symptoms and bleeding.

Drug interactions

  • P-gp inducers rifampin: Avoid coadministration with dabigatran.
  • P-gp inhibitors in patients with CrCl 30-50 mL/min: Consider reducing dose or avoid.
  • P-gp inhibitors in patients with CrCl <30 mL/min: Not recommended.

Use in specific populations

  • Geriatric use: Risk of bleeding increases with age.