139 CLINICAL CONSEQUENCES OF OFF-LABEL REDUCED DOSING OF NOACS IN AF Apixaban 5 mg b.d. → 2.5 mg b.d. - ≥2 of the following criteria: - Age ≥80 years - Serum creatinine ≥1.5 mg/dL (133 µmol/L) - Body weight ≤60 kg 5 mg b.d. → 2.5 mg b.d. - CrCl 15-29 mL/min/1.73 m2 - ≥2 of the following criteria: - Age ≥80 years - Serum creatinine ≥1.5 mg/dL (133 µmol/L) - Body weight ≤60 kg 5 mg b.d. → 2.5 mg b.d. - Concomitant dual inhibitors of P-gp and CYP3A4 - ≥2 of the following criteria: - Age ≥80 years - Serum creatinine ≥1.5 mg/dL - Body weight ≤60 kg 5 mg b.d. → 2.5 mg b.d. - ≥2 of the following criteria: - Age ≥80 years - Serum creatinine ≥1.5 mg/dL (133 µmol/L) - Body weight ≤60 kg 5 mg b.d. → 2.5 mg b.d. - CrCl 15-29 mL/min/1.73 m2 - ≥2 of the following criteria: - Age ≥80 years - Serum creatinine ≥1.5 mg/dL - Body weight ≤60 kg Consider dose reduction in case of ≥2 of the following criteria: - Age ≥75 years - Body weight ≤60 kg - Amiodarone, diltiazem, dronedarone, or naproxen use - Other reasons for increased bleeding risk Edoxaban 60 mg o.d. → 30 mg o.d. - CrCl 30-50 mL/min/1.73 m2 - Body weight ≤60 kg - Verapamil, quinidine, dronedarone 30 mg o.d. → 15 mg o.d. - CrCl 30-50 mL/min/1.73 m2 - Body weight ≤60 kg - Verapamil, quinidine, dronedarone 60 mg o.d. → 30 mg o.d. - CrCl 15-50 mL/min/1.73 m2 - Body weight ≤60 kg - Ciclosporin, ketoconazole, dronedarone, erythromycin 60 mg o.d. → 30 mg o.d. - CrCl 15-50 mL/min/1.73 m2 60 mg o.d. → 30 mg o.d. - CrCl 30-50 mL/min/1.73 m2 - Body weight ≤60 kg - Verapamil, quinidine, dronedarone 30 mg o.d. → 15 mg o.d. - CrCl 30-50 mL/min/1.73 m2 - Body weight ≤60 kg - Verapamil, quinidine, dronedarone 60 mg o.d. → 30 mg o.d. - CrCl 15-49 mL/min/1.73 m2 - Body weight ≤60 kg - Dronedarone, clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, voriconazole, cyclosporine, tacrolimus Consider dose reduction in case of ≥2 of the following criteria: - Age ≥75 years - Amiodarone, quinidine, verapamil - Other increased bleeding risk a ROCKET-AF b J-ROCKET-AF CrCl: creatinine clearance; eGFR: estimated Glomerular Filtration Rate; EHRA: European Heart Rhythm Association; ESC: European Society of Cardiology; FDA: Food and Drugs Administration; GERD: gastroesophageal reflux disease; SPC: Summary of Product Characteristic. 8
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