Rivaroxaban

XARELTO is a factor Xa inhibitor indicated: to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation 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 for thromboprophylaxis in pediatric…

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.

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.

XARELTO is contraindicated in patients with: active pathological bleeding severe hypersensitivity reaction to XARELTO (e.g., anaphylactic reactions) Active pathological bleeding. Severe hypersensitivity reaction to XARELTO

Boxed warning: Premature discontinuation of XARELTO increases the risk of thrombotic events Premature discontinuation of any oral anticoagulant, including XARELTO, increases the risk of thrombotic events. If anticoagulation with XARELTO is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. B. Risk of bleeding: XARELTO can cause serious and fatal bleeding. 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

The following clinically significant adverse reactions are also discussed in other sections of the labeling: Increased Risk of Stroke After Discontinuation in Nonvalvular Atrial Fibrillation Bleeding Risk Spinal/Epidural Hematoma 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

Avoid combined P-gp and strong CYP3A inhibitors and inducers. Anticoagulants: Avoid concomitant use General Inhibition and Induction Properties Rivaroxaban is a substrate of CYP3A4/5, CYP2J2, and the P-gp and ATP-binding cassette G2 (ABCG2) transporters, the latter also known as breast cancer resistance protein (BCRP). Combined P-gp and strong CYP3A inhibitors increase exposure to rivaroxaban and may increase the risk of bleeding. Combined P-gp and strong CYP3A inducers decrease exposure to rivaroxaban and may increase the risk of thromboembolic events. Drugs that Inhibit Cytochrome P450 3A Enzymes and Drug Transport Systems Interaction with Combined P-gp and Strong CYP3A Inhibitors Avoid concomitant administration of XARELTO with known combined P-gp and strong CYP3A inhibitors (e.g., ketoconazole and ritonavir).

Store at room temperature between 20 °C to 25 °C (68 °F to 77 °F), excursions permitted between 15 °C to 30 °C (59 °F to 86 °F). Do not freeze the granules or reconstituted suspension.