Select therapeutic use:
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, PE following 6 months treatment for DVT, PE. Prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
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: 20mg once daily. DVT, PE treatment, risk reduction: avoid use if CrCl<30mL/min. Prophylaxis of DVT (take 6–10hrs after surgery once hemostasis established): 10mg once daily; severe renal impairment (CrCl<30mL/min): avoid; moderate renal impairment (CrCl 30–50mL/min); monitor closely for blood loss. Hip: treat for 35 days. Knee: treat for 12 days. Switching from or to warfarin, or other anticoagulants: see full labeling.
Active pathological bleeding.
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; 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. ESRD on dialysis. Discontinue 24hrs before surgery. Elderly. Labor & delivery. Pregnancy (Cat.C); use with caution, risk of pregnancy-related hemorrhage. Nursing mothers: not recommended.
Increased risk of bleeding with concomitant aspirin, P2Y12 platelet inhibitors, other antithrombotic agents, fibrinolytic therapy, NSAIDs, clopidogrel, SSRIs, SNRIs; avoid. Avoid with concomitant combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir, conivaptan, clarithromycin). Avoid with concomitant combined P-gp and strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort). May be potentiated with concomitant renal impairment and combined P-gp and weak or moderate CYP3A4 inhibitors (eg, erythromycin, fluconazole, diltiazem, verapamil, dronedarone, amiodarone).
Factor Xa inhibitor.
Bleeding events (may be serious or fatal), wound secretion, pruritus, blister, pain in extremity, syncope, muscle spasm, back pain, abdominal pain.
Hepatic (CYP3A4/5, 2J2).
Tabs 10mg—30, 100 (10 x 10 blister cards); 15mg, 20mg—30, 90, 100 (10 x 10 blister cards); Starter Pack (for DVT/PE)—1 (51 tabs)