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.