What is the indication for Rivaroxaban (Xarelto)?

From the Guidelines

Rivaroxaban is indicated for the prevention of venous thromboembolism (VTE) in patients undergoing total hip replacement surgery and total knee replacement surgery, as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. The approved dose for VTE prevention after surgery is 10 mg once daily, started between 6 and 10 hours after surgery, and the duration of treatment varies from 2 weeks in patients undergoing total knee replacement surgery to 5 weeks in patients undergoing total hip replacement surgery 1. For DVT and PE treatment, the dose is 15 mg twice daily for 21 days, followed by 20 mg once daily 1. In patients with nonvalvular atrial fibrillation, the dose is 20 mg once daily, with a reduced dose of 15 mg daily for patients with renal impairment and a creatinine clearance of 15-49 mL/min 1.

Key Considerations

• Rivaroxaban is not approved for use in patients with severe renal failure, hepatic disease associated with coagulopathy, or those receiving concomitant systemic treatment with azole-antimycotics or HIV protease inhibitors 1.
• The drug is also not approved for use in children or adolescents under 18 years of age, pregnant women, or during breast-feeding due to the potential for reproductive toxicity and the evidence that the drug passes the placenta and is secreted into milk 1.
• Patients should be advised to take rivaroxaban consistently at the same time each day with food to maximize absorption and maintain steady blood levels.
• Common side effects include bleeding risk, and patients should avoid NSAIDs and other anticoagulants while taking it.
• In case of major bleeding, andexanet alfa can be used as a reversal agent.

Dosing and Administration

• The typical dosing for atrial fibrillation is 20 mg once daily with food 1.
• For DVT/PE treatment, it's 15 mg twice daily with food for 21 days, followed by 20 mg once daily 1.
• For DVT/PE prevention after surgery, 10 mg once daily is often prescribed 1.
• Rivaroxaban works by directly inhibiting Factor Xa in the coagulation cascade, preventing thrombin formation and subsequent clot development.
• Unlike warfarin, rivaroxaban doesn't require routine blood monitoring but does need dose adjustment in patients with renal impairment (15 mg daily when creatinine clearance is 15-49 mL/min) 1.

From the FDA Drug Label

1. INDICATIONS AND USAGE 1.1 Reduction of Risk of Stroke and Systemic Embolism in Nonvalvular Atrial Fibrillation XARELTO is indicated to reduce the risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation 1.2 Treatment of Deep Vein Thrombosis XARELTO is indicated for the treatment of deep vein thrombosis (DVT). 1.3 Treatment of Pulmonary Embolism XARELTO is indicated for the treatment of pulmonary embolism (PE). 1.4 Reduction in the Risk of Recurrence of Deep Vein Thrombosis and/or Pulmonary Embolism XARELTO is indicated for the reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months. 1.5 Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement Surgery XARELTO is indicated for the prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. 1.6 Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding XARELTO is indicated for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding 1.7 Reduction of Risk of Major Cardiovascular Events in Patients with Coronary Artery Disease (CAD) XARELTO, in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in adult patients with coronary artery disease. 1.8 Reduction of Risk of Major Thrombotic Vascular Events in Patients with Peripheral Artery Disease (PAD), Including Patients after Lower Extremity Revascularization due to Symptomatic PAD XARELTO, in combination with aspirin, is indicated to reduce the risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with PAD, including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. 1.9 Treatment of Venous Thromboembolism and Reduction in Risk of Recurrent Venous Thromboembolism in Pediatric Patients XARELTO is indicated for the treatment of venous thromboembolism (VTE) and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment. 1.10 Thromboprophylaxis in Pediatric Patients with Congenital Heart Disease after the Fontan Procedure XARELTO is indicated for thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure.

The indications for Rivaroxaban (Xarelto) are:

• Reduction of risk of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation
• Treatment of deep vein thrombosis (DVT)
• Treatment of pulmonary embolism (PE)
• Reduction in the risk of recurrence of DVT and/or PE in adult patients at continued risk for recurrent DVT and/or PE
• Prophylaxis of DVT following hip or knee replacement surgery
• Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding
• Reduction of risk of major cardiovascular events in patients with coronary artery disease (CAD)
• Reduction of risk of major thrombotic vascular events in patients with peripheral artery disease (PAD)
• Treatment of VTE and reduction in risk of recurrent VTE in pediatric patients
• Thromboprophylaxis in pediatric patients with congenital heart disease after the Fontan procedure 2

From the Research

Indications for Rivaroxaban (Xarelto)

The indications for Rivaroxaban (Xarelto) include:

• Prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 3, 4, 5
• Prevention of deep vein thrombosis in patients undergoing total hip replacement and total knee replacement 3, 4, 6
• Treatment of deep vein thrombosis and pulmonary embolism 3, 4, 6
• Reduction in risk of recurrence of deep vein thrombosis and pulmonary embolism 3, 4, 6

Approved Dose Schedules

The approved rivaroxaban dose schedule varies depending on the indication, including:

• 15 mg twice daily for 3 weeks followed by 20 mg once daily for the treatment of deep vein thrombosis and pulmonary embolism 6
• 20 mg once daily for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation 3, 4
• 10 mg once daily for the prevention of deep vein thrombosis in patients undergoing total hip replacement and total knee replacement 3, 4