【藥品性質提示】 根根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，用於治療75歲以上老年人VTE、Af、或腎功能不佳 (CrCl<50mL/min) 時須謹慎使用 #高警訊藥品

抗凝血口服
1. Venous thromboembolism: Treatment/reduction of recurrence of deep vein thrombosis (DVT) or pulmonary embolism (PE)
2. Nonvalvular Atrial fibrillation: Prevention of stroke and systemic embolism in adult patients with Af
3. Coronary artery disease: Reduction of risk of major cardiovascular events in adult patients with CAD
4. Peripheral artery disease: Reduction of risk of major thrombotic vascular events in adult patients with PAD
5. Thromboprophylaxis: For pediatric patients ≥2 years of age with congenital heart disease undergoing the Fontan procedure

Factor Xa Inhibitor; Direct Oral Anticoagulant (DOAC)
Inhibits platelet activation and fibrin clot formation via direct, selective and reversible inhibition of factor Xa (FXa) in both the intrinsic and extrinsic coagulation pathways. FXa, as part of the prothrombinase complex consisting also of factor Va, calcium ions, factor II and phospholipid, catalyzes the conversion of prothrombin to thrombin. Thrombin both activates platelets and catalyzes the conversion of fibrinogen to fibrin.

Absorption:
Bioavailability: 80-100%
Distribution:
Plasma protein binding: 92-95 %
Metabolism:
1. Hepatic via CYP3A4, CYP3A5, and CYP2J2
2. Elimination Half-life: (Young) 5-9 hrs; (Elderly) 11-13 hrs
Excretion:
Urine (33% as unchanged drug; 33% as inactive metabolites); feces (33% as inactive metabolites)

1. Hypersensitivity to rivaroxaban or any component of the formulation
2. Hepatic disease (including Child-Pugh classes B and C) associated with coagulopathy and clinically relevant bleeding risk
3. Clinically significant active bleeding or significant bleeding within previous 6 months; spontaneous hemostasis impairment
4. Concomitant systemic treatment with strong CYP3A4 and P-glycoprotein (P-gp) inhibitors
5. Pregnancy, lactation

C

contraindicated

Bleeding, anemia, increased GGT, increase transaminases, nausea

Venous thromboembolism:
1. DVT and/or PE: 15 mg twice daily with food for 21 days followed by 20 mg once daily with food
2. Indefinite anticoagulation (reduced intensity dosing for prophylaxis against VTE recurrence): 10 mg once daily
3. Acutely ill medical patients prophylaxis: 10 mg once daily for a total duration of 31 to 39 days
4. Total hip or knee arthroplasty prophylaxis: 10 mg once daily initiated ≥6-10 hours after surgery or when hemostasis established
Nonvalvular Atrial fibrillation:
20 mg once daily with the evening meal
Coronary artery disease (Stable), Peripheral artery disease (Stable):
2.5 mg twice daily; administer in combination with daily low dose aspirin

Venous thromboembolism:
1. CrCl ≥30 mL/minute: No dosage adjustment necessary
2. CrCl <30 mL/minute, Intermittent Hemodialysis, Peritoneal dialysis: Avoid use
Nonvalvular Atrial fibrillation:
1. CrCl >50 mL/minute: No dosage adjustment necessary
2. CrCl 15 to 50 mL/minute: 15 mg once daily with food (Patients with CrCl <30 mL/minute were excluded from clinical trials)
3. CrCl <15 mL/minute: Avoid use; apixaban or warfarin is preferred
4. Intermittent Hemodialysis, Peritoneal dialysis: Avoid use
Coronary artery disease (Stable), Peripheral artery disease (Stable):
1. CrCl ≥15 mL/minute: No dosage adjustment necessary; use with caution in severe impairment
2. CrCl <15 mL/minute, Intermittent Hemodialysis, Peritoneal dialysis: Avoid use

1. Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the manufacturer's labeling.
2. Moderate to severe impairment (Child-Pugh class B or C) and any hepatic disease associated with coagulopathy: Avoid use.