Adults

Administer the appropriate volume of the reconstituted Daptomycin for Injection (concentration of 50 mg/mL) to adult patients intravenously either by injection over a two (2) minute period or by intravenous infusion over a thirty (30) minute period [see Dosage and Administration (2.2, 2.3, 2.5)].

Adult Patients:

No dosage adjustment is required in adult patients with creatinine clearance (CLCR) greater than or equal to 30 mL/min. The recommended dosage regimen for Daptomycin for Injection in adult patients with CLCR less than 30 mL/min, including adult patients 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, Daptomycin for Injection should be administered following the completion of hemodialysis on hemodialysis days [see Warnings and Precautions (5.2, 5.10), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Pediatric Patients:

The dosage regimen for Daptomycin for Injection in pediatric patients with renal impairment has not been established.

Reconstitution of Daptomycin for Injection Vial

Daptomycin for Injection is supplied in single-dose vials, each containing 350 mg or 500 mg daptomycin as a sterile, lyophilized powder. The contents of a Daptomycin for Injection vial should be reconstituted, using aseptic technique, to 50 mg/mL as follows:

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

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Remove the polypropylene flip-off cap from the Daptomycin for Injection vial to expose the central portion of the rubber stopper. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry.

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Pierce the center of the rubber stopper with the syringe needle and GENTLY inject 10 mL of 0.9% sodium chloride injection directly over the Daptomycin for Injection 500 mg drug product or 7 mL of 0.9% sodium chloride injection directly over the Daptomycin for Injection 350 mg drug product. Release the syringe plunger and allow the syringe plunger to equalize the pressure before removing the syringe from the vial.

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Hold the vial by the vial neck, tilt the vial and swirl vial contents until the product is completely reconstituted.

Administration Instructions

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

Slowly remove reconstituted liquid (concentration of 50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter. Administer as an intravenous injection or infusion as described below:

Adults

In-Use Storage Conditions for Daptomycin for Injection Once Reconstituted in Acceptable Intravenous Diluents

Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature under normal room light and up to 48 hours if stored under refrigeration protected from light at 2°C to 8°C (36°F to 46°F).

The diluted solution is stable in the infusion bag for 12 hours under normal room light at room temperature and 48 hours (Lactated Ringer's) or 10 days (0.9% sodium chloride) if stored under refrigeration protected from light.

For Lactated Ringer's diluent, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 48 hours under refrigeration.

For 0.9% sodium chloride diluent, the combined storage time (reconstituted solution in vial and diluted solution in infusion bag) should not exceed 12 hours at room temperature or 10 days under refrigeration.