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. Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients 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 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 ≤50mL/min): 15mg once daily with the evening meal. Treatment of DVT, PE (CrCl ≥15mL/min): 15mg twice daily for first 21 days, then 20mg once daily. Reduction in risk of recurrence of DVT, PE at continued risk (CrCl ≥15mL/min): 10mg once daily, after ≥6 months of standard anticoagulant therapy. Prophylaxis of DVT (CrCl ≥15mL/min): 10mg once daily (take 6–10hrs after surgery once hemostasis established) for 35 days (hip) or 12 days (knee). Prophylaxis of VTE (CrCl ≥15mL/min): 10mg once daily (in hospital and after hospital discharge) for 31–39 days. CrCl <15mL/min: avoid use for DVT/VTE prophylaxis, DVT/PE risk reduction or treatment. 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. Do not use for primary VTE prophylaxis in hospitalized, acutely ill medical patients at high risk of bleeding (see full labeling). Patients with prosthetic heart valves, triple-positive antiphospholipid syndrome, pulmonary embolism (presenting hemodynamic instability), or those requiring thrombolysis or pulmonary embolectomy: not recommended. Moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. Assess renal function periodically; consider dose adjustment or discontinue if acute renal failure develops. Renal impairment: see full labeling. 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 CYP3A inhibitors (eg, ketoconazole, ritonavir). Increased thrombotic events with combined P-gp and strong CYP3A 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 CYP3A 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.
Generic Drug Availability:
Tabs 2.5mg—60, 180, 100 (10 x 10 blister cards); 10mg, 15mg—30, 90, 100 (10 x 10 blister cards); 20mg—30, 90, 1000, 100 (10 x 10 blister cards); Starter Pack (for DVT/PE)—1 (51 tabs)