These highlights do not include all the information needed to use CUBICIN safely and effectively.  See full prescribing information for CUBICIN. CUBICIN (daptomycin for injection) for Intravenous UseInitial U.S. Approval: 2003
CUBICIN (daptomycin for injection)

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

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 (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

CUBICIN is not indicated for the treatment of pneumonia.

CUBICIN is not indicated for the treatment of left-sided infective endocarditis due to S. aureus.  The clinical trial of CUBICIN in patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see Clinical Trials (14.2) ].  CUBICIN has not been studied in patients with prosthetic valve endocarditis.

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.  In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.  Empiric therapy may be initiated while awaiting test results.

CUBICIN should be administered intravenously either by injection over a two (2) minute period or by infusion over a thirty (30) minute period.

CUBICIN 4 mg/kg should be administered intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days.

CUBICIN 6 mg/kg should be administered intravenously in 0.9% sodium chloride injection once every 24 hours for 2 to 6 weeks.  There are limited safety data for the use of CUBICIN for more than 28 days of therapy.  In the Phase 3 trial, there were a total of 14 patients who were treated with CUBICIN for more than 28 days.

The recommended dosage regimen for patients with creatinine clearance (CL) <30 mL/min, including those on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), is 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours (Table 1).  When possible, CUBICIN should be administered following the completion of hemodialysis on hemodialysis days [see Warnings and Precautions (5.2, 5.7), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3) ].

Table 1.  Recommended Dosage of CUBICIN in Adult Patients Creatinine Clearance
(CLCR) Dosage Regimen
cSSSI S. aureus Bloodstream Infections
≥30 mL/min 4 mg/kg once