For patients with 非瓣膜性心房纖維顫動 (Non-Valvular Atrial Fibrillation; NVAF) and 靜脈栓塞 (Venous Thromboembolism; VTE), and if one or more of the following clinical factors are present : 1.CrCl 15–50 mL/min 2.Body Weight ? 60 kg 3.Concomitant use of P-glycoprotein (P-gp) Inhibitors, such as: cyclosporine, dronedarone, erythromycin, or ketoconazole 【文字內容來自仿單】

Anticoagulant, Direct factor Xa Inhibitor<20220113>; Direct Oral AnticoagulantEdoxaban reduces generation of thrombin and thrombus formation by inhibiting free factor Xa, prothrombinase activity, and thrombin-induced platelet aggregation.

■ Distribution: Vdss: 107 L■ Protein binding: ~55%■ Metabolism: Minimal via hydrolysis, conjugation and oxidation by CYP3A4; predominant metabolite (M-4) is active (<10% of parent compound)■ Bioavailability: 62%■ Half-life elimination: 10 to 14 hours■ Time to peak: 1 to 2 hours■ Excretion: Urine (primarily unchanged); renal clearance: ~50% of total clearance

1. Active pathological bleeding; Conditions at increased risk of significant bleeding (recent hemorrhagic or ischemic cerebral infarction)2. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk3. Pregnant or breastfeeding women

C (FDA)

Infant risk cannot be ruled out (MDX)

Common:Hemorrhage (oral, dermal, gastrointestinal, vaginal, hematuria, pharyngeal), anemia, decreased hemoglobin; skin rash; abnormal hepatic function tests; epistaxisPostmarketing:1. Hemorrhagic stroke2. Interstitial pulmonary disease (confounded by concomitant amiodarone therapy and infectious pneumonia)3. Intracranial hemorrhage (includes epidural hematoma, nonhemorrhagic stroke with major hemorrhagic conversion, primary hemorrhagic stroke, subarachnoid hemorrhage, subdural hematoma)

■ Deep vein thrombosis and pulmonary embolism:1. Patient weight >60 kg: 60 mg once daily after 5 to 10 days of initial therapy with a parenteral anticoagulant2. Patient weight ?60 kg: 30 mg once daily3. Concomitant therapy with specific P-gp inhibitors (ie, verapamil, quinidine; the short-term use of azithromycin, clarithromycin, erythromycin, oral itraconazole, oral ketoconazole): 30 mg once daily■ Nonvalvular atrial fibrillation (NVAF) (to prevent stroke and systemic embolism):1. Patient weight >60 kg: 60 mg once daily 2. Patient weight ?60 kg: 30 mg once daily 3. Geriatric patients ?65 years: Refer to adult dosing4. For elderly patients (approximately ?80 years old) who meet the following two criteria, 15 mg orally once daily may be considered (1) Presence of at least one of the following bleeding risk factors :i. History of major bleeding involving vital organs, including intracranial hemorrhage, intraocular bleeding, or gastrointestinal bleedingii. Body Weight ? 45 kgiii. CrCl ? 15 mL/min and < 30 mL/miniv. Frequent use of NSAIDsv. Use of Antiplatelet agents(2) Patients unable to receive the standard dose of LixianaR or other approved oral anticoagulants due to bleeding risk.

The safety and efficacy of edoxaban have not been established in children and adolescents younger than 18 years

■ Deep vein thrombosis and pulmonary embolism:1.CrCl >95 mL/min: Use is not recommended 2. CrCl ?51 mL/min: No dosage adjustment recommended3. CrCl 15 to 50 mL/min: 30 mg once daily4. CrCl <15 mL/min: Use is not recommended■ Nonvalvular atrial fibrillation:1. CrCl >95 mL/min: Use is not recommended (due to increased risk of ischemic stroke)2. CrCl 51 to 95 mL/min: No dosage adjustment recommended3. CrCl 15 to 50 mL/min: 30 mg once daily4. CrCl <15 mL/min: Use is not recommended5. ESRD requiring hemodialysis: Not dialyzable

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.Moderate to severe impairment (Child-Pugh class B and C): Use is not recommended.