DOSAGE AND ADMINISTRATION
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 CLCR ≥30 mL/min and 4 mg/kg (cSSSI) or 6 mg/kg (S. aureus bloodstream infections) once every 48 hours for patients with CLCR <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 Creatinine Clearance (CLCR) | Dosage Regimen |
cSSSI | S. aureus Bloodstream Infections |
≥30 mL/min | 4 mg/kg once every 24 hours | 6 mg/kg once every 24 hours |
<30 mL/min, including | 4 mg/kg once every 48 hours | 6 mg/kg once every 48 hours |
hemodialysis or CAPD | | |
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.
-
Remove the polypropylene flip-off cap from the CUBICIN vial to expose the central portion of the rubber stopper.
-
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.
-
Ensure that the entire CUBICIN product is wetted by gently rotating the vial.
-
Allow the product to stand undisturbed for 10 minutes.
-
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 8ºC (36 to 46ºF). 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 should not be used in conjunction with ReadyMED® elastomeric infusion pumps (Cardinal Health, Inc.) because of incompatibility due to an impurity leaching from this pump system into the CUBICIN solution.
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.
|