DAPTOMYCIN-AFT POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

**2 DOSAGE AND ADMINISTRATION** **2.1 GENERAL** Daptomycin-AFT is given by intravenous (IV) administration. Daptomycin-AFT is a sterile product contained in a single-dose vial. **2.2 ADULTS** **2.2.1 Complicated Skin and Skin Structure Infections** Daptomycin-AFT 4 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 7 to 14 days, either by injection over a 2-minute period or by infusion over a 30-minute period. Do not dose Daptomycin-AFT more frequently than once a day, and measure creatine phosphokinase (CPK) levels at baseline and at regular intervals (at least weekly). \[See 3 INSTRUCTIONS FOR USE, 3.1 Preparation of Daptomycin-AFT for Administration. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] **2.2.2 _Staphylococcus aureus_ Bloodstream Infections (Bacteremia)** Daptomycin-AFT 6 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 2 to 6 weeks, either by injection over a 2-minute period or by infusion over a 30-minute period. Duration of treatment is based on the treating physician’s working diagnosis. Do not dose Daptomycin-AFT more frequently than once a day, and measure CPK levels at baseline and at regular intervals (at least weekly). \[See 3 INSTRUCTIONS FOR USE, 3.1 Preparation of Daptomycin-AFT for Administration. – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\] **2.3 PEDIATRIC PATIENTS (1 TO 17 YEARS OF AGE)** **2.3.1 Complicated Skin and Skin Structure Infections** The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Daptomycin-AFT should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 14 days. Unlike in adults, Daptomycin-AFT should not be administered by injection over a two (2) minute period in pediatric patients.  **2.3.2 _Staphylococcus aureus_ Bloodstream Infections (Bacteremia)** The recommended dosage regimens based on age for pediatric patients with _S. aureus_ bloodstream infections (bacteremia) are shown in Table 2. Daptomycin-AFT should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 42 days.  **2.4 RENAL IMPAIRMENT** Daptomycin is eliminated primarily by the kidneys; therefore, an adjustment of Daptomycin-AFT dosage interval is recommended for adult patients with creatinine clearance (CLCR) <30 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). The recommended dosing regimen for these adult patients is 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours. When possible, administer Daptomycin-AFT following the completion of hemodialysis on hemodialysis days. In adult patients with renal impairment, monitor both renal function and CPK more frequently than once weekly. No dosage interval adjustment is required for adult patients with CLCR ≥30 mL/min. Due to limited clinical experience, Daptomycin-AFT should only be used in adult patients with any degree of renal impairment (creatinine clearance <80 mL/min) when it is considered that the expected clinical benefit outweighs the potential risk. The response to treatment and renal function should be closely monitored in all adult patients with some degree of renal impairment.  The dosage regimen for Daptomycin-AFT in pediatric patients with renal impairment has not been established.