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Rivaroxaban​

Brand and Other Names: Xarelto
Mechanism of Action:
XARELTO is a selective inhibitor of FXa. It does not require a cofactor (such as Anti-thrombin III) for activity. Rivaroxaban inhibits free FXa and prothrombinase activity. Rivaroxaban has no direct effect on platelet aggregation, but indirectly inhibits platelet aggregation induced by thrombin. By inhibiting FXa, rivaroxaban decreases thrombin generation.
Indications:

XARELTO is a factor Xa inhibitor indicated:
• to reduce risk of stroke and systemic embolism in nonvalvular atrialvfibrillation.
• for treatment of deep vein thrombosis (DVT).
• for treatment of pulmonary embolism (PE).
• for reduction in the risk of recurrence of DVT or PE.
• for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
• for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients.
• to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD).
• to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD.
• for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years. See package insert for complete information.

Route: Oral
Dose:

• Nonvalvular Atrial Fibrillation: 15 or 20 mg, once daily with food.
• Treatment of DVT and/or PE: 15 mg orally twice daily with food for the first 21 days followed by 20 mg orally once daily with food for the remaining treatment.
• Reduction in the Risk of Recurrence of DVT and/or PE in patients at continued risk for DVT and/or PE: 10 mg once daily with or without food, after at least 6 months of standard anticoagulant treatment.
• Prophylaxis of DVT Following Hip or Knee Replacement Surgery: 10 mg orally once daily with or without food.
• Prophylaxis of VTE in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding: 10 mg once daily, with or without food, in hospital and after hospital discharge for a total recommended duration of 31 to 39 days.
• CAD or PAD: 2.5 mg orally twice daily with or without food, in combination with aspirin (75-100 mg) once daily. See package insert for complete information.

Adverse Reactions:

• The most common adverse reaction (>5%) in adult patients was bleeding.
• The most common adverse reactions (>10%) in pediatric patients were bleeding, cough, vomiting, and gastroenteritis.

Contraindication:

• Active pathological bleeding.
• Severe hypersensitivity reaction to XARELTO.

Warnings and Precautions:

• Risk of bleeding: XARELTO can cause serious and fatal bleeding. An agent to reverse the activity of rivaroxaban is available.
• Pregnancy-related hemorrhage: Use XARELTO with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery.
• Prosthetic heart valves: XARELTO use not recommended.
• Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: XARELTO use not recommended.

See package insert for full prescribing information.