XARELTO® (Rivaroxaban)

XARELTO® (Rivaroxaban) is an oral anticoagulant that works as a direct Factor Xa inhibitor. It is commonly used for the prevention and treatment of thromboembolic disorders. Below are general guidelines for its use, which are subject to clinical judgment and individual patient factors. Always consult the latest clinical guidelines or local protocols for specific recommendations.

Indications

1. Prevention of stroke and systemic embolism:
   • In non-valvular atrial fibrillation (NVAF) with a CHA₂DS₂-VASc score indicating moderate to high risk.
2. Treatment of venous thromboembolism (VTE):
   • Deep vein thrombosis (DVT) and pulmonary embolism (PE).
3. Prevention of recurrent DVT and PE:
   • After initial treatment.
4. Postoperative thromboprophylaxis:
   • Following hip or knee replacement surgery.
5. Secondary prevention of cardiovascular events:
   • In combination with low-dose aspirin in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Dosage and Administration

• Stroke Prevention in NVAF:
  • Standard dose: 20 mg once daily with food.
  • Adjust to 15 mg once daily if CrCl is 15–49 mL/min.
• Treatment of DVT/PE:
  • Initial: 15 mg twice daily for 21 days.
  • Maintenance: 20 mg once daily with food.
• Prevention of Recurrent DVT/PE:
  • After at least 6 months of initial treatment: 10 mg once daily.
• Postoperative Thromboprophylaxis:
  • Hip replacement: 10 mg once daily for 35 days.
  • Knee replacement: 10 mg once daily for 12–14 days.
  • Start 6–10 hours after surgery, provided hemostasis is achieved.
• Secondary Prevention in CAD/PAD:
  • 2.5 mg twice daily with aspirin (75–100 mg daily).

Contraindications

• Active bleeding.
• Severe hypersensitivity to XARELTO® Rivaroxaban.
• Significant hepatic impairment associated with coagulopathy.
• Pregnancy and lactation (unless specifically advised).
• Concomitant use with strong inhibitors/inducers of CYP3A4 and P-gp.

Monitoring

• Routine anticoagulation monitoring is not required.
• Check renal function at baseline and periodically (especially in elderly or those with comorbidities).
• Assess for signs of bleeding or thromboembolic complications.

Special Considerations

• Renal impairment: Dose adjustment is required for CrCl <50 mL/min. Avoid use if CrCl <15 mL/min.
• Hepatic impairment: Avoid in moderate to severe liver disease.
• Perioperative management: Discontinue 24–48 hours before surgery, depending on bleeding risk. Resume once adequate hemostasis is achieved.
• Reversal agent: Andexanet alfa can be used in cases of life-threatening bleeding. Supportive measures and activated charcoal (if recent ingestion) may be considered.

Side Effects

• Common: Bleeding (e.g., epistaxis, gastrointestinal bleeding), anemia.
• Rare but serious: Intracranial hemorrhage, hypersensitivity reactions, liver enzyme elevation.

For more detailed guidance, refer to clinical guidelines such as those from the European Society of Cardiology (ESC), American College of Cardiology (ACC), or CHEST Guidelines.