Dosage and administration

Nonvalvular atrial fibrillation

CrCl Dose
>95 mL/min DO NOT USE!
>50 to ≤95 mL/min 60 mg PO once daily
≥15 to <50 mL/min 30 mg PO once daily
<15 mL/min DO NOT USE!

Note: Do not use with CrCl >95 mL/min!

DVT and PE

CrCl Dose
>50 mL/min 60 mg orally once daily
≥15 to <50 mL/min 30 mg orally once daily

Patients with body weight ≤60 kg or receiving certain P-gp inhibitors (verapamil, quinidine, azithromycin, clarithromycin, erythromycin, itraconazole or ketoconazole) use 30 mg once daily.

Dosage forms and strengths

  • Tablets
    • 15 mg
    • 30 mg
    • 60 mg

Contraindications

  • Active pathological bleeding

Warnings and precautions

  • Bleeding: serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss.
  • Mechanical heart valves or moderate to severe mitral stenosis: Use is not recommended.

Adverse reactions

  • Treatment of nonvalvular AF: The most common adverse reactions (≥5%) are bleeding and anemia.
  • Treatment of DVT and PE: The most common adverse reactions (≥1%) are bleeding, rash, abnormal liver function tests and anemia.

Drug interactions

  • Anticoagulants: Avoid concomitant use.
  • Rifampin: Avoid concomitant use.

Use in specific populations

  • Nursing mothers: Discontinue drug or discontinue nursing.
  • Impaired renal function: Reduce dose (see tables above).
  • Moderate or severe hepatic impairment: Not recommended.