|Updated Box warning regarding premature discontinuation increases risk of thrombotic events.|
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 pulmonary embolism in patients undergoing knee or hip replacement surgery.
15mg and 20mg tablets: take with food. Unable to swallow whole tablets: may crush 15mg or 20mg tabs and mix with applesauce immediately prior to use, then follow with food; may also 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; CrCl <15mL/min: avoid. 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 6–10 hours 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; discontinue if acute renal failure develops. Hip: treat for 35 days. Knee: treat for 12 days. Switching from or to warfarin, or other anticoagulants: see full labeling.
Factor Xa inhibitor.
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: not recommended. Moderate or severe hepatic impairment, hepatic disease associated with coagulopathy: avoid. 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; avoid. Avoid with concomitant combined P-gp and strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir, conivaptan). 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, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, felodipine).
Bleeding events (may be serious or fatal), wound secretion, pain in extremity, muscle spasm, syncope, pruritus, blister; hypersensitivity reactions.
Hepatic (CYP3A4/5, 2J2).
Tabs 10mg—30, 100 (10 x 10 blister cards); 15mg, 20mg—30, 90, 100 (10 x 10 blister cards)