Daptomycin (Page 2 of 14)

2.5 Dosage in Pediatric Patients (1 to 17 Years of Age) with 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 2. Administer daptomycin for injection intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days.

Table 2: Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with S. aureus Bacteremia, Based on Age

Age group

Dosage*

Duration of therapy

12 to 17 years

7 mg/kg once every 24 hours infused over 30 minutes

Up to 42 days

7 to 11 years

9 mg/kg once every 24 hours infused over 30 minutes

1 to 6 years

12 mg/kg once every 24 hours infused over 60 minutes

*Recommended dosage is for pediatric patients (1 to 17 years of age) with normal renal function. Dosage adjustment for pediatric patients with renal impairment has not been established.

2.6 Dosage in Patients with Renal Impairment

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 3). 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)].

Table 3: Recommended Dosage of Daptomycin for Injection in Adult Patients

Creatinine Clearance

(CLCR )

Dosage Regimen in Adults

cSSSI

S. aureus Bloodstream Infections

Greater than or equal to 30mL/min

4 mg/kg once

every 24 hours

6 mg/kg once every 24 hours

Less than 30 mL/min, including hemodialysis and CAPD

4 mg/kg once

every 48 hours*

6 mg/kg once every 48 hours*

*When possible, administer daptomycin for injection following the completion of hemodialysis, on hemodialysis days.

Pediatric Patients:

The dosage regimen for daptomycin for injection in pediatric patients with renal impairment has not been established.

2.7 Preparation and Administration of Daptomycin for Injection

There are other formulations of daptomycin that have differences concerning reconstitution and storage. Carefully follow the reconstitution and storage procedures described in this labeling.

Reconstitution of Daptomycin for Injection Vial

Daptomycin for injection is supplied in single-dose vials, each containing 500 mg daptomycin as a sterile, lyophilized powder. The contents of a daptomycin for injection vial should be reconstituted with 0.9% sodium chloride injection, using aseptic technique, to 50 mg/mL as follows:

  1. To minimize foaming, AVOID vigorous agitation or shaking of the vial during or after reconstitution.
  2. Remove the polypropylene flip-off cap from the daptomycin for injection vial to expose the central portion of the rubber stopper.
  3. 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.
  4. Slowly transfer 10 mL of 0.9% sodium chloride injection through the center of the rubber stopper into the daptomycin for injection 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.
  5. Ensure that all of the daptomycin for injection powder is wetted by gently rotating the vial.
    1. Allow the wetted product to stand undisturbed for 10 minutes.
    2. Gently 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 (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

Intravenous Injection over a period of 2 minutes

  • For intravenous (IV) injection over a period of 2 minutes in adult patients only: Administer the appropriate volume of the reconstituted daptomycin for injection (concentration of 50 mg/mL).

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 daptomycin for injection (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.

Pediatric Patients (1 to 17 Years of Age)

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