Xarelto Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
See Also
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Xarelto Indications
Indications
To reduce the risk of stroke and systemic embolism in adults with nonvalvular atrial fibrillation. Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE). To reduce 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 ≥6 months. Prophylaxis of DVT, which may lead to PE in adult patients undergoing knee or hip replacement surgery. Prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adults 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. In combination with aspirin, to reduce the risk of major cardiovascular (CV) events in adults with coronary artery disease (CAD). In combination with aspirin, to reduce the risk of major thrombotic vascular events in adults with peripheral artery disease (PAD), including those who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD. Treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in pediatric patients from birth to <18yrs after at least 5 days of initial parenteral anticoagulant treatment. Thromboprophylaxis in pediatric patients aged ≥2yrs with congenital heart disease after undergoing the Fontan procedure.
Xarelto Dosage and Administration
Adult
Children
Renal Impairment
-
Nonvalvular Atrial Fibrillation
-
Monitor renal function periodically as clinically indicated and adjust therapy accordingly.
-
Consider dose adjustment or discontinuation of Xarelto in patients who develop acute renal failure.
-
Treatment of DVT, PE, and Reduction in the Risk of Recurrence of DVT and of PE
-
For patients with CrCl 15–<30mL/min: monitor closely and promptly evaluate any signs or symptoms of blood loss.
-
For patients with CrCl <15 mL/min including dialysis patients: avoid use of Xarelto.
-
Discontinue Xarelto if acute renal failure develops.
-
Prophylaxis of DVT Following Hip or Knee Replacement Surgery
-
For patients with CrCl 15–<30mL/min: monitor closely and promptly evaluate any signs or symptoms of blood loss.
-
For patients with CrCl <15 mL/min including dialysis patients: avoid use of Xarelto.
-
Discontinue Xarelto if acute renal failure develops.
-
Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Patients at Risk for Thromboembolic Complications Not at High Risk of Bleeding
-
For patients with CrCl 15–<30mL/min: monitor closely and promptly evaluate any signs or symptoms of blood loss.
-
For patients with CrCl <15 mL/min including dialysis patients: avoid use of Xarelto.
-
Discontinue Xarelto if acute renal failure develops.
-
Pediatric Patients
-
For pediatric patients 1 year of age and older with moderate to severe renal impairment (eGFR <50 mL/min/1.73m2): avoid use of Xarelto.
-
For pediatric patients less than 1 year with serum creatinine results above 97.5th percentile: avoid use of Xarelto.
Hepatic Impairment
-
Avoid use of Xarelto in patients with moderate and severe hepatic impairment or patients with any hepatic disease associated with coagulopathy.
Other Modifications
Females and Males of Reproductive Potential
-
Assess the risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, with the use of Xarelto in females of reproductive potential and those with abnormal uterine bleeding.
Administration
Nursing Considerations
Xarelto Contraindications
Contraindications
Xarelto Boxed Warnings
Boxed Warning
Xarelto Warnings/Precautions
Warnings/Precautions
Xarelto Pharmacokinetics
Absorption
-
Absolute bioavailability for the 2.5 mg and 10 mg dose: ~80 to 100% and is not affected by food.
-
Absolute bioavailability for the 20 mg in the fasted state: ~66% and is increased when taken with food.
-
Xarelto 15 mg and 20 mg should be taken with food.
-
Maximum concentrations of rivaroxaban: ~2 to 4 hours after intake.
-
Avoid administering rivaroxaban distal to the stomach because it can results in reduced absorption.
Distribution
-
Protein binding: ~92 to 95% with albumin being the main binding component.
-
Steady-state volume of distribution: ~50 L.
Elimination
-
Renal (30%), fecal (21%).
-
Terminal half-life: ~5–9 hours (20–45 years of age); 11–13 hours (60–76 years of age).
Xarelto Interactions
Interactions
Xarelto Adverse Reactions
Adverse Reactions
Xarelto Clinical Trials
Xarelto Note
Not Applicable
Xarelto Patient Counseling
Cost Savings Program
Images
