Daptomycin

DAPTOMYCIN- daptomycin injection, powder, lyophilized, for solution
NorthStar RxLLC

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1 INDICATIONS AND USAGE

1.1 Complicated Skin and Skin Structure Infections (cSSSI)

Daptomycin for injection is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) Daptomycin for injection is indicated for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates),Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis , and Enterococcus faecalis (vancomycin-susceptible isolates only).

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

Daptomycin for injection is indicated for the treatment of adult patients with Staphylococcus aureus bloodstream infections (bacteremia), including adult patients with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant isolates.

1.3 Staphylococcus aureus Bloodstream Infections (Bacteremia) in Pediatric Patients (1 to 17 Years of Age)

Daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia).

1.4 Limitations of Use

Daptomycin for injection is not indicated for the treatment of pneumonia.

Daptomycin for injection is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The clinical trial of daptomycin for injection in adult patients with S. aureus bloodstream infections included limited data from patients with left-sided infective endocarditis; outcomes in these patients were poor [see Clinical Trials (14.2)]. Daptomycin for injection has not been studied in patients with prosthetic valve endocarditis.

Daptomycin for injection is not recommended in pediatric patients younger than 1 year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal dogs [see Warnings and Precautions ( 5.7) and Nonclinical Toxicology (13.2)].

1.5 Usage

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to daptomycin.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for injection and other antibacterial drugs, daptomycin for injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information is available, it should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Empiric therapy may be initiated while awaiting test results.

2 DOSAGE AND ADMINISTRATION

2.1 Important Administration Duration Instructions

Adults:

Administer the appropriate volume of the reconstituted daptomycin for injection (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 daptomycin by injection over a two (2) minute period to pediatric patients.

  • Pediatric Patients 7 to 17 years of Age: Administer daptomycin for injection 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 daptomycin for injection intravenously by infusion over a 60-minute period [see Dosage and Administration (2.3, 2.5, 2.7)].

2.2 Dosage in Adults for cSSSI

Administer daptomycin for injection 4 mg/kg to adult patients intravenously in 0.9% sodium chloride injection once every 24 hours for 7 to 14 days.

2.3 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 daptomycin intravenously in 0.9% sodium chloride injection once every 24 hours for up to 14 days.

Table 1: Recommended Dosage of Daptomycin for Injection in Pediatric Patients (1 to 17 Years of Age) with cSSSI, Based on Age

Age Range Dosage Regimen* Duration of therapy
12 to 17 years 5 mg/kg once every 24 hours infused over 30 minutes Up to 14 days
7 to 11 years 7 mg/kg once every 24 hours infused over 30 minutes
2 to 6 years 9 mg/kg once every 24 hours infused over 60 minutes
1 to less than 2 years 10 mg/kg once every 24 hours infused over 60 minutes
*Recommended dosage regimen 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.

2.4 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 daptomycin for injection 6 mg/kg to adult patients intravenously in 0.9% sodium chloride injection 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.

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

Creatinin e Clearance(CLCR ) Dosage Regimen in Adults
cSSSI S. aureus Bloods tream Infections
Greater than or equal to 30 mL/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.

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