Increased risk of hemorrhage eg, congenital or acquired bleeding disorders; active ulcerative GI disease; bacterial endocarditis; thrombocytopenia; platelet disorders; history of haemorrhagic stroke; severe uncontrolled HTN; recent brain, spinal or ophthalmological surgery. Discontinue in the event of hemorrhagic complications & consider initiation of appropriate treatment (eg, surgical hemostasis or fresh frozen plasma transfusion). Renal impairment (CrCl <15 mL/min). Contraindicated in patients w/ hepatic disease associated w/ coagulopathy & clinically relevant bleeding risk. Not recommended in patients w/ severe hepatic impairment. Patients w/ mild or moderate hepatic impairment (Child Pugh A or B). Low body wt (<60 kg). Patients receiving concomitant systemic treatment w/ strong inhibitors of both CYP3A4 & P-gp eg, azole antimycotics (eg, ketoconazole, itraconazole, voriconazole & posaconazole) & HIV-PIs (eg, ritonavir); strong CYP3A4 & P-gp inducers (eg, rifampin, phenytoin, carbamazepine, phenobarb or St. John's wort). Patients receiving concomitant systemic treatment w/ strong inducers of both CYP3A4 & P-gp for the prevention of VTE in elective hip or knee replacement surgery, stroke in patients w/ NVAF. Patients treated concomitantly w/ medicinal products affecting haemostasis eg, NSAIDs, ASA, platelet aggregation inhibitors or other antithrombotic agents. Spinal/epidural anaesth or puncture. Hip fracture surgery. Patients w/ prosthetic heart valves w/ or w/o atrial fibrillation. Patients w/ rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Childn <18 yr. Elderly.