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

For intravenous (IV) injection over a period of 2 minutes, administer the appropriate volume of the reconstituted CUBICIN (concentration of 50 mg/mL).

For IV infusion over a period of 30 minutes, the appropriate volume of the reconstituted CUBICIN (concentration of 50 mg/mL) should be further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection.

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

No preservative or bacteriostatic agent is present in this product.  Aseptic technique must be used in the preparation of final IV solution.  Stability studies have shown that the reconstituted solution is stable in the vial for 12 hours at room temperature and 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 and 48 hours if stored under refrigeration.  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.

CUBICIN vials are for single use only.

CUBICIN is compatible with 0.9% sodium chloride injection and lactated Ringer's injection.

CUBICIN is not compatible with dextrose-containing diluents.

CUBICIN should not be used in conjunction with ReadyMED elastomeric infusion pumps (Cardinal Health, Inc.).  Stability studies of CUBICIN solutions stored in ReadyMED elastomeric infusion pumps identified an impurity (2-mercaptobenzothiazole) leaching from this pump system into the CUBICIN solution.

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

500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-use vial.

CUBICIN is contraindicated in patients with known hypersensitivity to daptomycin.

Anaphylaxis/hypersensitivity reactions have been reported with the use of antibacterial agents, including CUBICIN, and may be life-threatening.  If an allergic reaction to CUBICIN occurs, discontinue the drug and institute appropriate therapy [see Adverse Reactions (6.2) ].

Myopathy, defined as muscle aching or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values to greater than 10 times the upper limit of normal (ULN), has been reported with the use of CUBICIN.  Rhabdomyolysis, with or without acute renal failure, has been reported [see Adverse Reactions (6.2) ].

Patients receiving CUBICIN should be