PFIZER DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL [SIN16443P]

Product Info

PFIZER DAPTOMYCIN POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500 MG/VIAL

[SIN16443P]

4.1 Therapeutic indications

Daptomycin is indicated for the treatment of the infections listed below.

Complicated skin and skin structure infections
Adult (≥ 18 years of age) and paediatric (1 to 17 years of age) patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).

Staphylococcus aureus bloodstream infections (bacteraemia)
Adult patients (≥ 18 years of age) with Staphylococcus aureus bloodstream infections (bacteraemia), including those with right-sided infective endocarditis (SAB/RIE), caused by methicillin-susceptible and methicillin-resistant isolates.

Paediatric patients (1 to 17 years of age) with S. aureus bloodstream infections (bacteraemia) caused by methicillin-susceptible and methicillin-resistant isolates.

Daptomycin is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The efficacy of daptomycin in patients with left-sided infective endocarditis due to S.aureus has not been demonstrated. The clinical study of daptomycin in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor. Daptomycin has not been studied in patients with prosthetic valve endocarditis.

Daptomycin is not indicated for the treatment of pneumonia (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Daptomycin is given by intravenous (IV) administration.

Daptomycin is a sterile product contained in a single-dose vial.

Adults

Complicated skin and skin structure infections
Daptomycin 4 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride solution 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 more frequently than once a day, and measure creatine phosphokinase (CPK) levels at baseline and at regular intervals (at least weekly). Refer to section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Staphylococcus aureus bloodstream infections (bacteraemia)
Daptomycin 6 mg/kg is administered to adult patients intravenously in 0.9% sodium chloride solution 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 more frequently than once a day, and measure CPK levels at baseline and at regular intervals (at least weekly) Refer to section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric patients (1 to 17 years of age)

Complicated skin and skin structure infections
The recommended dose regimens based on age for paediatric patients with cSSSI are shown in Table 1. Daptomycin should be administered intravenously in 0.9% sodium chloride solution for injection once every 24 hours for up to 14 days.

Unlike in adults, Daptomycin should not be administered by injection over a 2-minute period in paediatric patients.

Staphylococcus aureus bloodstream infections (bacteraemia)
The recommended dose regimens based on age for paediatric patients with S. aureus bloodstream infections (bacteraemia) are shown in Table 2. Daptomycin should be administered intravenously in 0.9% sodium chloride solution for injection once every 24 hours for up to 42 days.

Special population

Renal impairment
Daptomycin is eliminated primarily by the kidney; therefore, an adjustment of daptomycin dosage interval is recommended for adult patients with creatinine clearance (CL_CR) < 30 mL/min, including patients receiving haemodialysis 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 following the completion of haemodialysis on haemodialysis 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 CL_CR ≥ 30 mL/min.

Due to limited clinical experience, daptomycin should only be used in adult patients with any degree of renal impairment (CL_CR < 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 patients with some degree of renal impairment.

Dose adjustments in adult patients with renal impairment by indication and creatinine clearance:

The dose regimen for daptomycin in paediatric patients with renal impairment has not been established.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.