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Cubicin RF Dosage

Generic name: Daptomycin 500mg in 10mL
Dosage form: injection, powder, lyophilized, for solution

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The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Administration Duration

CUBICIN RF should be administered intravenously either by injection over a two (2) minute period or by infusion over a thirty (30) minute period.

Complicated Skin and Skin Structure Infections

CUBICIN RF 4 mg/kg should be administered intravenously once every 24 hours for 7 to 14 days.

Staphylococcus aureus Bloodstream Infections (Bacteremia), Including Those with Right-Sided Infective Endocarditis, Caused by Methicillin-Susceptible and Methicillin-Resistant Isolates

CUBICIN RF 6 mg/kg should be administered intravenously once every 24 hours for 2 to 6 weeks. 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.

Patients with Renal Impairment

The recommended dosage regimen for patients with creatinine clearance (CLCR) less than 30 mL/min, including 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, CUBICIN RF should be administered following the completion of hemodialysis on hemodialysis days [see Warnings and Precautions (5.2, 5.8), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].

Table 1: Recommended Dosage of CUBICIN RF in Adult Patients
Creatinine Clearance
(CLCR)
Dosage Regimen
cSSSI S. aureus Bloodstream Infections
*
When possible, administer CUBICIN RF following the completion of hemodialysis on hemodialysis days.
≥30 mL/min 4 mg/kg once every 24 hours 6 mg/kg once every 24 hours
<30 mL/min, including hemodialysis and CAPD 4 mg/kg once every 48 hours* 6 mg/kg once every 48 hours*

Preparation of CUBICIN RF for Administration

Reconstitution of CUBICIN RF Vial

CUBICIN RF must be reconstituted within the vial only with either Sterile Water for Injection or Bacteriostatic Water for Injection.

Do NOT use saline based diluents for the reconstitution in the vial because this will result in a hyperosmotic solution that may result in infusion site reactions if the reconstituted product is administered as an intravenous injection over a period of 2 minutes.

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

  1. Remove the polypropylene flip-off cap from the CUBICIN RF 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. Transfer 10 mL of Sterile Water for Injection or Bacteriostatic Water for Injection through the center of the rubber stopper into the CUBICIN RF vial. Use a beveled sterile transfer needle that is 21 gauge or smaller in diameter, pointing the transfer needle toward the wall of the vial.
  4. Rotate or swirl the vial contents for a few minutes, as needed, to obtain a completely reconstituted solution.

Administration Instructions

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

Slowly remove reconstituted liquid containing daptomycin (50 mg/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:

Intravenous Injection over a period of 2 minutes

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

Intravenous Infusion over a period of 30 minutes

For intravenous (IV) infusion over a period of 30 minutes, the appropriate volume of the reconstituted CUBICIN RF (concentration of 50 mg/mL) should be further diluted, into a 50 mL IV infusion bag containing 0.9% sodium chloride injection. This transfer should be done using aseptic technique involving a beveled sterile needle that is 21 gauge or smaller in diameter.

No preservative or bacteriostatic agent is present in this product. Aseptic technique must be used in the preparation of final IV solution. Table 2 below provides in-use storage conditions for reconstituted CUBICIN RF in acceptable intravenous diluents in the syringe, vial and intravenous bag (for reconstitution and dilution). Do not exceed the listed shelf-life of reconstituted and diluted solutions of CUBICIN RF. Discard unused portions of CUBICIN RF.

Table 2: In-Use Storage Conditions for CUBICIN RF Once Reconstituted in Acceptable Intravenous Diluents
Container Diluent In-Use Shelf-Life
Room Temperature
(20°C–25°C, 68°F–77°F)
Refrigerated
(2°C–8°C, 36°F–46°F)
*
Polypropylene syringe with elastomeric plunger stopper.
Vial Sterile Water for Injection 1 Day 3 Days
Bacteriostatic Water for Injection 2 Days 3 Days  
Syringe* Sterile Water for Injection 1 Day 3 Days
Bacteriostatic Water for Injection 2 Days 5 Days  
Intravenous Bag Reconstitution: Sterile Water for Injection for immediate dilution with 0.9% sodium chloride injection 19 Hours 3 Days
Reconstitution: Bacteriostatic Water for Injection for immediate dilution with 0.9% sodium chloride injection 2 Days 5 Days  

Compatible Intravenous Solutions

Reconstituted CUBICIN RF is compatible with Sterile Water for Injection, Bacteriostatic Water for Injection, and 0.9% sodium chloride injection. [See Dosage and Administration (2.5).]

Incompatibilities

CUBICIN RF is incompatible with dextrose-containing diluents.

CUBICIN RF should not be used in conjunction with ReadyMED® elastomeric infusion pumps. 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 RF with other IV substances, additives and other medications should not be added to CUBICIN RF single-dose vials or infusion bags, or infused simultaneously with CUBICIN RF 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 RF.

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