Discontinue treatment if severe haemorrhage occurs; in the event of hemorrhagic complications; for active bleeding, elective surgery, or invasive procedures w/ increased risk of thrombosis to patients; at least 48 hr prior to elective surgery or invasive procedure w/ moderate or high risk of unacceptable or clinically significant bleeding, or at least 24 hr prior to elective surgery or invasive procedures w/ low risk of bleeding or where bleeding would be non-critical. Not recommended in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk; prosthetic heart valves w/ or w/o atrial fibrillation; patients undergoing hip fracture surgery. Not recommended as alternative to unfractionated heparin for initial treatment of patients w/ PE w/ haemodynamic instability or who may receive thrombolysis or pulmonary embolectomy. Increased risk of haemorrhage eg, 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 ophthalmological surgery; developing epidural or spinal haematoma resulting to long-term or permanent paralysis when neuraxial anaesth (spinal/epidural anaesth) or spinal/epidural puncture is employed. Patients w/ atrial fibrillation & conditions that warrant mono or dual antiplatelet therapy. Carefully observe signs of bleeding. Frequently monitor patients w/ signs & symptoms of neurological impairment (eg, numbness or weakness of the legs, bowel or bladder dysfunction). Administer 4-factor prothrombin complex conc; recombinant factor VIIa to reverse bleeding. Concomitant use w/ antiplatelet agents; NSAIDs including ASA; other platelet aggregation inhibitors or antithrombotic agents; strong CYP3A4 & P-gp inhibitors eg, azole-antimycotics (eg, ketoconazole, itraconazole, voriconazole, posaconazole), HIV PI (eg, ritonavir), & inducers (eg, rifampicin, phenytoin, carbamazepine, phenobarb or St. John's Wort). Not recommended in renal (CrCl <15 mL/min) & severe hepatic impairment; patients undergoing dialysis. Mild or moderate hepatic impairment (Child Pugh A or B). Not recommended during pregnancy. Lactation. Childn & adolescents <18 yr.
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