CUBICIN (daptomycin for injection) is indicated for the following infections (see also DOSAGE AND ADMINISTRATION and CLINICAL STUDIES):

Complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only). Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms.

Staphylococcus aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates. Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative or anaerobic organisms.

The efficacy of CUBICIN in patients with left-sided infective endocarditis due to S. aureus has not been demonstrated. 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 STUDIES). CUBICIN has not been studied in patients with prosthetic valve endocarditis or meningitis.

Patients with persisting or relapsing S. aureus infection or poor clinical response should have repeat blood cultures. If a culture is positive for S. aureus, MIC susceptibility testing of the isolate should be performed using a standardized procedure, as well as diagnostic evaluation to rule out sequestered foci of infection (see PRECAUTIONS).

CUBICIN is not indicated for the treatment of pneumonia.

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin. Empiric therapy may be initiated while awaiting test results. Antimicrobial therapy should be adjusted as needed based upon test results.

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 or prevent 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.

Complicated Skin and Skin Structure Infections

CUBICIN 4 mg/kg should be administered over a 30-minute period by IV infusion in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days. In Phase 1 and 2 clinical studies, CPK elevations appeared to be more frequent when CUBICIN was dosed more frequently than once daily. Therefore, CUBICIN should not be dosed more frequently than once a day.

Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates

CUBICIN 6 mg/kg should be administered over a 30-minute period by IV infusion in 0.9% sodium chloride injection once every 24 hours for a minimum of 2 to 6 weeks. Duration of treatment should be based on the treating physician's working diagnosis. There are limited safety data for the use of CUBICIN for more than 28 days of therapy. In the Phase 3 study, there were a total of 14 patients who were treated with CUBICIN for more than 28 days, 8 of whom were treated for 6 weeks or longer.

In Phase 1 and 2 clinical studies, CPK elevations appeared to be more frequent when CUBICIN was dosed more frequently than once daily. Therefore, CUBICIN should not be dosed more frequently than once a day.

Patients with Renal Impairment

Because daptomycin is eliminated primarily by the kidney, a dosage modification is recommended for patients with creatinine clearance < 30 mL/min, including patients receiving hemodialysis or CAPD, as listed in Table 9. The recommended dosing regimen is 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 24 hours for patients with CL_CR ≥ 30 mL/min and 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours for patients with CL_CR < 30 mL/min, including those on hemodialysis or CAPD. In patients with renal insufficiency, both renal function and CPK should be monitored more frequently. When possible, CUBICIN should be administered following hemodialysis on hemodialysis days (see CLINICAL PHARMACOLOGY).

Table 9. Recommended Dosage of CUBICIN (daptomycin for injection) in Adult Patients

Preparation of CUBICIN for Administration

CUBICIN is supplied in single-use vials containing 500 mg daptomycin as a sterile, lyophilized powder. The contents of a CUBICIN 500 mg vial should be reconstituted using aseptic technique as follows:

Note: To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.

1. Remove the polypropylene flip-off cap from the CUBICIN vial to expose the central portion of the rubber stopper.
2. Slowly transfer 10 mL of 0.9% sodium chloride injection through the center of the rubber stopper into the CUBICIN vial, pointing the transfer needle toward the wall of the vial.
3. Ensure that the entire CUBICIN product is wetted by gently rotating the vial.
4. Allow the product to stand undisturbed for 10 minutes.
5. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution.

Reconstituted CUBICIN should be further diluted with 0.9% sodium chloride injection to be administered by IV infusion over a period of 30 minutes.

Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of final IV solution. Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature or up to 48 hours if stored under refrigeration at 2 to 8°C (36 to 46°F). The diluted solution is stable in the infusion bag for 12 hours at room temperature or 48 hours if stored under refrigeration. The combined time (vial and infusion bag) at room temperature should not exceed 12 hours; the combined time (vial and infusion bag) under refrigeration should not exceed 48 hours.

CUBICIN vials are for single use only.

Parenteral drug products should be inspected visually for particulate matter prior to administration.

Because only limited data are available on the compatibility of CUBICIN with other IV substances, additives or other medications should not be added to CUBICIN single-use vials or infused simultaneously through the same IV line. If the same IV line is used for sequential infusion of several different drugs, the line should be flushed with a compatible infusion solution before and after infusion with CUBICIN.

Compatible Intravenous Solutions

CUBICIN is compatible with 0.9% sodium chloride injection and lactated Ringer's injection. CUBICIN is not compatible with dextrose-containing diluents.

CUBICIN (daptomycin for injection) – Pale yellow to light brown lyophilized cake Single-use 10 mL capacity vial, 500 mg/vial: Package of 1 (NDC 67919-011-01)

Storage

Store original packages at refrigerated temperatures, 2 to 8°C (36 to 46°F); avoid excessive heat.

Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA. For all medical inquiries call: (866) 793-2786. March 2007. FDA Rev date: 10/5/2007

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