【藥品性質提示】 根據 2019 AGS Beers Criteria，本藥品為【潛在不適當用藥 (PIM)】，腎功能不佳之老年人 (CrCl<15mL/min 或 >95mL/min) 須避免使用、CrCl 15-50mL/min 須降低劑量。 #高警訊藥品

抗凝血口服 Deep vein thrombosis and pulmonary embolism; Nonvalvular atrial fibrillation
#仿單變更2022

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

Absorption Bioavailability: 62-72.3%
Distribution VD: 107-149.7 L
Metabolism Liver: Minimal
Excretion Renal: 50%
Elimination Half-life 10-14 hours

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 risk
3. 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; epistaxis
Postmarketing:
1. Hemorrhagic stroke
2. 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 anticoagulant
2. Patient weight ≤60 kg: 30 mg once daily
3. 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):
60 mg once daily
Geriatric patients ≥65 years:
Refer to adult dosing

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 ≥51 mL/min: No dosage adjustment recommended
2. CrCl 15 to 50 mL/min: 30 mg once daily
3. 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 recommended
3. CrCl 15 to 50 mL/min: 30 mg once daily
4. CrCl <15 mL/min: Use is not recommended
5. ESRD requiring hemodialysis: Not dialyzable
Geriatric patients ≥65 years:
1. CrCl 30 to 50 mL/min: Dose should be reduced
2. CrCl <30 mL/min: Avoid use due to increased risk of bleeding

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