Conditions w/ increased risk of hemorrhage e.g., congenital or acquired bleeding disorders, active ulcerative GI disease, bacterial endocarditis, thrombocytopenia, platelet disorders, history of hemorrhagic stroke, severe uncontrolled HTN, & recent brain, spinal or ophth surgery.
Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; undergoing hip fracture surgery; prosthetic heart valves w/ or w/o atrial fibrillation.
Discontinue if severe hemorrhage occurs.
Temporarily discontinue for active bleeding, elective surgery, or invasive procedures; avoid lapses in therapy & restart as soon as possible.
Risk of developing spinal or epidural hematoma during spinal/epidural anesthesia or puncture which can result in long-term or permanent paralysis. Indwelling epidural or intrathecal catheters must be removed at least 5 hr prior to the 1st dose.
Frequently monitor for signs & symptoms of neurological impairment. Not recommended as an alternative to unfractionated heparin for the initial treatment of patients w/ PE who present w/ hemodynamic instability or who may receive thrombolysis of pulmonary embolectomy.
Not recommended for patients w/ history of thrombosis who are diagnosed w/ antiphospholipid syndrome.
Carefully assess patients w/ atrial fibrillation & conditions that warrants mono or dual antiplatelet therapy.
Concomitant use w/ strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole), HIV PIs (eg, ritonavir); strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarbital or St. John's wort); antiplatelet agents; NSAIDs including ASA; other platelet aggregation inhibitors or other antithrombotic agents.
Not recommended in patients w/ CrCl <15 mL/min or those undergoing dialysis, or w/ severe hepatic impairment. Mild or moderate hepatic impairment (Child Pugh A or B).
Not recommended during pregnancy. Lactation. Children <18 yr.
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