Cubicin Dosage/Direction for Use

CUBICIN should be administered intravenously.
Adults: Complicated Skin and Skin Structure Infections: CUBICIN 4 mg/kg should be administered to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 7 to 14 days by infusion over a 30-minute period.
Staphylococcus aureus Bloodstream Infections (Bacteremia): CUBICIN 6 mg/kg should be administered to adult patients intravenously in 0.9% sodium chloride for injection once every 24 hours for 2 to 6 weeks by infusion over a 30-minute period. There are limited safety data for the use of CUBICIN for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 patients who were treated with CUBICIN for more than 28 days.
Pediatric Patients (1 to 17 Years of Age): Complicated Skin and Skin Structure Infections: The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 3. CUBICIN should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 14 days. (See Table 3.)

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Staphylococcus aureus Bloodstream Infections (Bacteremia): The recommended dosage regimens based on age for pediatric patients with S. aureus bloodstream infections (bacteremia) are shown in Table 4. CUBICIN should be administered intravenously in 0.9% sodium chloride for injection once every 24 hours for up to 42 days. (See Table 4.)

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Patients with Renal Impairment: The recommended dosage regimen for adult patients with creatinine clearance (CL_CR) <30 mL/min, including those 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 5). When possible, CUBICIN should be administered following the completion of hemodialysis on hemodialysis days (see Precautions and Pharmacology under Actions).
The dosage regimen for CUBICIN pediatric patients with renal impairment has not been established. (See Table 5.)

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Preparation of CUBICIN for Administration: CUBICIN is supplied in single-dose 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: 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. Wipe the top of the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the rubber stopper or allow it to touch any other surface.
3. Slowly transfer 10 mL of 0.9% sodium chloride for injection through the center of the rubber stopper into the CUBICIN vial, pointing the transfer needle toward the wall of the vial. It is recommended that a beveled sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device is used, pointing the transfer needle toward the wall of the vial.
4. Ensure that all of the CUBICIN powder is wetted by gently rotating the vial.
5. Allow the wetted product to stand undisturbed for 10 minutes.
6. Gently rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution.
7. Slowly remove reconstituted liquid (50 mg daptomycin/mL) from the vial using a beveled sterile needle that is 21 gauge or smaller in diameter.
Adults: Intravenous Infusion over a period of 30 minutes: For IV infusion over a period of 30 minutes in adult patients, 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 for injection.
Pediatric Patients (1 to 17 Years of Age): Intravenous Infusion over a period of 30 or 60 minutes: For IV infusion over a period of 30 minutes in pediatric patients, reconstituted CUBICIN (concentration of 50 mg/mL) is further diluted, using aseptic technique, into a 50 mL IV infusion bag containing 0.9% sodium chloride for injection. The infusion rate should be maintained at 1.67 mL/min over the 30 minute period.
For IV infusion over a period of 60 minutes in pediatric patients, reconstituted CUBICIN (concentration of 50 mg/mL) is further diluted, using aseptic technique, into an IV infusion bag containing 25 mL of 0.9% sodium chloride for injection. The infusion rate should be maintained at 0.42 mL/min over the 60 minute period.
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 at 2 to 8°C (36 to 46°F). 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 at 2 to 8°C (36 to 46°F).
CUBICIN vials are for single use only.
Compatible Intravenous Solutions: The compatible diluent for reconstitution is 0.9% sodium chloride for injection and lactated Ringer's injection.
For IV infusion, reconstituted CUBICIN (concentration of 50 mg/mL) is further diluted, using aseptic technique, with 0.9% sodium chloride for injection.
Reconstitute CUBICIN, as directed previously, to a concentration of 50 mg/mL with 0.9% sodium chloride for injection. Further dilute using aseptic technique with additional 0.9% sodium chloride for injection to a final concentration in the range of 2.5 to 20 mg/mL (typically 10 mg/mL). (See Table 6.)

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Method/Route of Administration: CUBICIN is given by intravenous (IV) infusion.