DAPTOMYCIN injection, powder, lyophilized, for solution

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DAPTOMYCIN (UNII: NWQ5N31VKK) (DAPTOMYCIN - UNII:NWQ5N31VKK)

Доступно од:

Fresenius Kabi USA, LLC

INN (Међународно име):

DAPTOMYCIN

Састав:

DAPTOMYCIN 500 mg in 10 mL

Пут администрације:

INTRAVENOUS

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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) 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). 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. Daptomycin for injection is indicated for the treatment of pediatric patients (1 to 17 years of age) with Staphylococcus aureus bloodstream infections (bacteremia). 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 Studies (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)] . 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 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. Daptomycin for injection is contraindicated in patients with known hypersensitivity to daptomycin [see Warnings and Precautions (5.1)] . Risk Summary Limited published data on use of Daptomycin for injection in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies performed in rats and rabbits daptomycin was administered intravenously during organogenesis at doses 2 and 4-times, respectively, the recommended 6 mg/kg human dose (on a body surface area basis). No evidence of adverse developmental outcomes was observed. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In pregnant rats, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 18. Maternal body weight gain was decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than in humans at the recommended maximum dose of 6 mg/kg (based on body surface area). In pregnant rabbits, daptomycin was administered intravenously at doses of 5, 20, or 75 mg/kg/day during the gestation days 6 to 15. Maternal body weight gain and food consumption were decreased at 75 mg/kg/day. No embryo/fetal effects were noted at the highest dose of 75 mg/kg/day, a dose approximately 4-fold higher than in humans at the maximum recommended dose of 6 mg/kg (based on body surface area). In a combined fertility and pre/postnatal development study, daptomycin was administered intravenously to female rats at doses of 2, 25, 75 mg/kg/day from 14-days pre-mating through lactation/postpartum day 20). No effects on pre/postnatal development were observed up to the highest dose of 75 mg/kg/day, a dose approximately 2-fold higher than the maximum recommended human dose of 6 mg/kg (based on body surface area)1 . Risk Summary Limited published data report that daptomycin is present in human milk at infant doses of 0.1% of the maternal dose [see Data] 2,3,4 . There is no information on the effects of daptomycin on the breastfed infant or the effects of daptomycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Daptomycin for injection and any potential adverse effects on the breastfed infant from Daptomycin for injection or from the underlying maternal condition. The safety and effectiveness of Daptomycin for injection in the treatment of cSSSI and S. aureus bloodstream infections (bacteremia) have been established in the age groups 1 to 17 years of age. Use of Daptomycin for injection in these age groups is supported by evidence from adequate and well-controlled studies in adults, with additional data from pharmacokinetic studies in pediatric patients, and from safety, efficacy and PK studies in pediatric patients with cSSSI and S. aureus bloodstream infections [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1, 14.2)] . Safety and effectiveness in pediatric patients below the age of one year have not been established. Avoid use of Daptomycin for injection in pediatric patients younger than one 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)] . Daptomycin for injection is not indicated in pediatric patients with renal impairment because dosage has not been established in these patients. Daptomycin for injection has not been studied in pediatric patients with other bacterial infections. Of the 534 adult patients treated with Daptomycin for injection in Phase 3 controlled clinical trials of complicated skin and skin structure infections (cSSSI), 27% were 65 years of age or older and 12% were 75 years of age or older. Of the 120 adult patients treated with Daptomycin for injection in the Phase 3 controlled clinical trial of S. aureus bacteremia/endocarditis, 25% were 65 years of age or older and 16% were 75 years of age or older. In Phase 3 adult clinical trials of cSSSI and S. aureus bacteremia/endocarditis, clinical success rates were lower in patients ≥65 years of age than in patients <65 years of age. In addition, treatment-emergent adverse events were more common in patients ≥65 years of age than in patients <65 years of age. The exposure of daptomycin was higher in healthy elderly subjects than in healthy young adult subjects. However, no adjustment of Daptomycin for injection dosage is warranted for elderly patients with creatinine clearance (CLCR) ≥30 mL/min [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3)] . Daptomycin is eliminated primarily by the kidneys; therefore, a modification of Daptomycin for injection dosage interval is recommended for adult patients with CLCR <30 mL/min, including patients receiving hemodialysis or continuous ambulatory peritoneal dialysis (CAPD). In adult patients with renal impairment, both renal function and creatine phosphokinase (CPK) should be monitored more frequently than once weekly [see Dosage and Administration (2.6), Warnings and Precautions (5.2, 5.10), and Clinical Pharmacology (12.3)] . The dosage regimen for Daptomycin for injection in pediatric patients with renal impairment has not been established.

Резиме производа:

Daptomycin for injection is supplied as a sterile pale yellow to light brown lyophilized cake in a single-dose 15 mL vial containing 500 mg of daptomycin: Package of 1 (NDC 63323-871-15). Store original packages at refrigerated temperatures, 2°C to 8°C (36°F to 46°F); avoid excessive heat. Storage conditions for the reconstituted and diluted solutions are described in another section of the prescribing information [see Dosage and Administration (2.7)].

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

DAPTOMYCIN- DAPTOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAPTOMYCIN FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DAPTOMYCIN FOR
INJECTION.
DAPTOMYCIN FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
RECENT MAJOR CHANGES
Dosage and Administration (2)
2/2022
Warnings and Precautions, Development of Drug-Resistant Bacteria
(5.12)
10/2021
INDICATIONS AND USAGE
Daptomycin for injection is a lipopeptide antibacterial indicated for
the treatment of:
Complicated skin and skin structure infections (cSSSI) in adult and
pediatric patients (1 to 17 years of
age) (1.1) and,
_Staphylococcus aureus_ bloodstream infections (bacteremia), in adult
patients including those with
right-sided infective endocarditis, (1.2)
_Staphylococcus aureus_ bloodstream infections (bacteremia) in
pediatric patients (1 to 17 years of age).
(1.3)
Limitations of Use:
Daptomycin for injection is not indicated for the treatment of
pneumonia. (1.4)
Daptomycin for injection is not indicated for the treatment of
left-sided infective endocarditis due to _S._
_aureus_. (1.4)
Daptomycin for injection is not recommended in pediatric patients
younger than one 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. (1.4)
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 to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria. (1.5)
DOSAGE AND ADMINISTRATION
Adult Patients
Administer to ADULT PATIENTS intravenously in 0.9% sodium chloride,
either by injection over a 2-
minute period or by infusion over a 30-minute period. (2.1, 2.7)
Recommended dosage regimen for adult patients (2.2, 2.4, 2.6):
CREAT