Dapzura RT Dosage

Important Administration Duration Instructions

Adults

Administer the appropriate volume of the reconstituted DAPZURA RT (concentration of 50 mg/mL) to adult patients intravenously either by injection over a two (2) minute period or by intravenous infusion over a thirty (30) minute period [see Dosage and Administration (2.2, 2.4, 2.7)].

Pediatric Patients (1 to 17 Years of Age)

Unlike in adults, do NOT administer DAPZURA RT by injection over a two (2) minute period to pediatric patients.

•

Pediatric Patients 7 to 17 years of Age: Administer DAPZURA RT intravenously by infusion over a 30-minute period [see Dosage and Administration (2.3, 2.5, 2.7)].

•

Pediatric Patients 1 to 6 years of Age: Administer DAPZURA RT intravenously by infusion over a 60-minute period [see Dosage and Administration (2.3, 2.5, 2.7)].

Dosage in Adults for cSSSI

Administer DAPZURA RT 4 mg/kg to adult patients intravenously once every 24 hours for 7 to 14 days.

Dosage in Pediatric Patients (1 to 17 Years of Age) for cSSSI

The recommended dosage regimens based on age for pediatric patients with cSSSI are shown in Table 1. Administer DAPZURA RT intravenously once every 24 hours for up to 14 days.

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

Administer DAPZURA RT 6 mg/kg to adult patients intravenously once every 24 hours for 2 to 6 weeks. There are limited safety data for the use of daptomycin for injection for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with daptomycin for injection for more than 28 days.

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 DAPZURA RT intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days.

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 DAPZURA RT 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, DAPZURA RT 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)].

Pediatric Patients:

The dosage regimen for DAPZURA RT in pediatric patients with renal impairment has not been established.

Preparation and Administration of DAPZURA RT

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 DAPZURA RT Vial

DAPZURA RT 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.

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

1.

Remove the polypropylene flip-off cap from the DAPZURA RT 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 DAPZURA RT 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 (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 DAPZURA RT (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 DAPZURA RT (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)

Intravenous Infusion over a period of 30 or 60 minutes

•

Unlike in Adults, do NOT administer DAPZURA RT by injection over a two (2) minute period to pediatric patients [see Dosage and Administration (2.1)].

•

For Intravenous infusion over a period of 60 minutes in pediatric patients 1 to 6 years of age: The appropriate volume of the reconstituted DAPZURA RT (concentration of 50 mg/mL) should be further diluted, using aseptic technique, into an intravenous infusion bag containing 25 mL of 0.9% sodium chloride injection. The infusion rate should be maintained at 0.42 mL/minute over the 60-minute period.

•

For Intravenous infusion over a period of 30 minutes in pediatric patients 7 to 17 years of age: The appropriate volume of the reconstituted DAPZURA RT (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. The infusion rate should be maintained at 1.67 mL/minute over the 30-minute period.

No preservative or bacteriostatic agent is present in this product. Aseptic technique must be used in the preparation of final IV solution. Table 4 below provides in-use storage conditions for reconstituted DAPZURA RT 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 DAPZURA RT. Discard unused portions of DAPZURA RT.

Compatible Intravenous Solutions

Reconstituted DAPZURA RT is compatible with Sterile Water for Injection, Bacteriostatic Water for Injection, and 0.9% sodium chloride injection. [See Dosage and Administration (2.7)]

Incompatibilities

Daptomycin for injection is not compatible with dextrose-containing diluents.

DAPZURA RT should not be used in conjunction with ReadyMED® elastomeric infusion

pumps. Stability studies of daptomycin for injection solutions stored in ReadyMED®

elastomeric infusion pumps identified an impurity (2-mercaptobenzothiazole) leaching

from this pump system into the daptomycin for injection solution.

Because only limited data are available on the compatibility of daptomycin for injection with other IV substances, additives and other medications should not be added to DAPZURA RT single-dose vials or infusion bags, or infused simultaneously with DAPZURA RT 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 DAPZURA RT.