Cubicin
CUBICIN- daptomycin injection, powder, lyophilized, for solution
Merck Sharp & Dohme LLC
1 INDICATIONS AND USAGE
1.1 Complicated Skin and Skin Structure Infections (cSSSI)
CUBICIN® is indicated for the treatment of adult and pediatric patients (1 to 17 years of age) 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
CUBICIN 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)
CUBICIN 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
CUBICIN is not indicated for the treatment of pneumonia.
CUBICIN is not indicated for the treatment of left-sided infective endocarditis due to S. aureus. The clinical trial of CUBICIN 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 Studies (14.2)]. CUBICIN has not been studied in patients with prosthetic valve endocarditis.
CUBICIN 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 CUBICIN and other antibacterial drugs, CUBICIN should be used only to treat or prevent 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 CUBICIN (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 CUBICIN by injection over a two (2) minute period to pediatric patients.
- Pediatric Patients 7 to 17 years of Age: Administer CUBICIN 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 CUBICIN 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 CUBICIN 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 CUBICIN intravenously in 0.9% sodium chloride injection once every 24 hours for up to 14 days.
| Age Range | Dosage Regimen * | Duration of therapy |
|---|---|---|
| ||
| 12 to 17 years | 5 mg/kg once every 24 hours infused over 30 minutes | |
| 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 | Up to 14 days |
| 1 to less than 2 years | 10 mg/kg once every 24 hours infused over 60 minutes | |
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 CUBICIN 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 CUBICIN for more than 28 days of therapy. In the Phase 3 trial, there were a total of 14 adult patients who were treated with CUBICIN 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 CUBICIN intravenously in 0.9% sodium chloride injection once every 24 hours for up to 42 days.
| Age group | Dosage * | Duration of therapy |
|---|---|---|
| ||
| 12 to 17 years | 7 mg/kg once every 24 hours infused over 30 minutes | |
| 7 to 11 years | 9 mg/kg once every 24 hours infused over 30 minutes | Up to 42 days |
| 1 to 6 years | 12 mg/kg once every 24 hours infused over 60 minutes | |
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