Table 1.
Characteristic | Daptomycin for injection for IV use | Daptomycin RF for injection for IV use | |
---|---|---|---|
Vial storage | • Refrigerated (2°C–8°C [36°F–46°F]) | • Controlled room temperature (20°C–25°C [68°F–77°F]; excursions permitted to 15°C–30°C [59°F–86°F]) | |
Diluent for vial reconstitution | • 0.9% sodium chloride | • Sterile water or bacteriostatic water for injection | |
Compatible IV solutions | • Daptomycin is compatible with 0.9% sodium chloride injection and lactated Ringer’s injection | • Reconstituted daptomycin RF is compatible with sterile water for injection, bacteriostatic water for injection, and 0.9% sodium chloride injection | |
Reconstitution of vial in preparation for administration | • To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution • Ensure that all the daptomycin powder is wetted by gently rotating the vial • Allow the wetted product to stand undisturbed for 10 minutes before gently rotating or swirling the vial contents for a few minutes to reconstitute |
• Upon wetting the daptomycin RF powder with the diluent, the vial contents can be rotated and swirled immediately for a few minutes to reconstitute | |
Approximate osmolalitya of 50 mg/mL | • 364 mOsm/kg when reconstituted in 0.9% sodium chloride injection | • 323 mOsm/kg when reconstituted in water for injection | |
In-use storage period (once reconstituted) | |||
Vial | Sodium chloride for injection | Sterile water for injection | Bacteriostatic water for injection |
Room temperatureb | • 12 hours | • 1 day | • 2 days |
Refrigeratedc | • 48 hours | • 3 days | • 3 daysd |
IV bag preparation | Reconstitution: 0.9% sodium chloride for injection for immediate dilution with 0.9% sodium chloride injection | Reconstitution: sterile water for injection for immediate dilution with 0.9% sodium chloride injection | Reconstitution: bacteriostatic water for injection for immediate dilution with 0.9% sodium chloride injection |
Room temperatureb | • 12 hours | • 19 hours | • 2 days |
Refrigeratedc | • 48 hours | • 3 days | • 5 days |
Syringe | No in-use storage period specified in prescribing information | Sterile water for injection | Bacteriostatic water for injection |
Room temperatureb | • N/A | • 1 day | • 2 days |
Refrigeratedc | • N/A | • 3 days | • 5 days |
Notes: Data from package inserts of Cubicin® (daptomycin for injection)4 and Cubicin® RF (daptomycin for injection).7
Osmolality refers to the number of solute particles per kilogram of water; osmolarity refers to the number of solute particles per liter of water. Osmolarity is considered roughly equivalent to osmolality (ie, 1 L is approximately equal to 1 kg) because normal saline is a dilute aqueous solution with a specific gravity of 1.0003.
Room temperature = 20°C–25°C (68°F–77°F).
Refrigerated temperature = 2°C–8°C (36°F–46°F).
Storage period is determined by sterility rather than stability of reconstituted product. Daptomycin RF is a new formulation of daptomycin for injection.
Abbreviations: IV, intravenous; N/A, not applicable.