Generic Name and Formulations:
Rivaroxaban 2.5mg, 10mg, 15mg, 20mg; tabs.
Janssen Pharmaceuticals, Inc.
Indications for XARELTO:
To reduce the risk of stroke and systemic embolism in patients 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 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 patients undergoing knee or hip replacement surgery. In combination with aspirin, to reduce the risk of major cardiovascular events (CV death, MI, stroke) in chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
15mg and 20mg tabs: take with food. Unable to swallow whole tabs: may crush tabs and mix with applesauce immediately prior to use, or give by NG or gastric tube (see full labeling). Nonvalvular atrial fibrillation: CrCl >50mL/min: 20mg once daily with the evening meal; CrCl 15–50mL/min: 15mg once daily with the evening meal. Treatment of DVT, PE: 15mg twice daily for first 21 days, then 20mg once daily for remaining treatment. Reduction in risk of recurrence of DVT, PE at continued risk: 10mg once daily, after ≥6 months of standard anticoagulant therapy. Prophylaxis of DVT (take 6–10hrs after surgery once hemostasis established): 10mg once daily for 35 days (hip) or 12 days (knee). CrCl<30mL/min: avoid use for DVT/PE treatment, risk reduction, or prophylaxis. Reduction in risk of major CV events: 2.5mg twice daily (w. aspirin). Switching from or to warfarin, or other anticoagulants: see full labeling.
Active pathological bleeding.
Premature discontinuation increases risk of thrombotic events. Spinal/epidural hematoma.
Premature discontinuation increases risk of thrombotic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture (see full labeling); monitor for signs/symptoms of neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Patients with prosthetic heart valves, PE patients with hemodynamic instability, or those requiring thrombolysis or pulmonary embolectomy: not recommended. Moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. Monitor renal function periodically; consider dose adjustment or discontinue if acute renal failure develops. Discontinue ≥24hrs before surgery. Elderly. Labor & delivery. Pregnancy: risk of pregnancy-related hemorrhage. Nursing mothers.
Factor Xa inhibitor.
Increased risk of bleeding with concomitant aspirin, clopidogrel, enoxaparin, warfarin, chronic NSAIDs. Avoid concomitant aspirin, P2Y12 platelet inhibitors, dual antiplatelet therapy, other antithrombotic agents, fibrinolytic therapy, NSAIDs, SSRIs, SNRIs, combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir). Increased thrombotic events with combined P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort); avoid. Renal impairment (CrCl 15–<80mL/min): do not use Xarelto if receiving concomitant combined P-gp and moderate CYP3A4 inhibitors (eg, erythromycin), unless benefit justifies the risk.
Bleeding events (may be serious or fatal), back pain, wound secretion, pruritus, pain in extremity, abdominal pain, blister.
Hepatic (CYP3A4/5, 2J2).
Tabs 2.5mg—60, 180, 100 (10 x 10 blister cards); 10mg, 15mg, 20mg—30, 90, 100 (10 x 10 blister cards); Starter Pack (for DVT/PE)—1 (51 tabs)