oli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [seeClinical Studies (14)].
1.2 Complicated Intra-abdominal Infections (cIAI)
RECARBRIO is indicated in patients 18 years of age and older who have limited or no alternativetreatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by thefollowing susceptible gram-negative microorganisms: Bacteroides caccae, Bacteroides fragilis,Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis,Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacteriumnucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis,and Pseudomonas aeruginosa.
Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [seeClinical Studies (14)].
1.3 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO andother antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are provenor strongly suspected to be caused by susceptible bacteria. When culture and susceptibility informationare available, they should be considered in selecting or modifying antibacterial therapy. In the absence ofsuch data, local epidemiology and susceptibility patterns may contribute to the empiric selection oftherapy.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage in Adults
The recommended dosage of RECARBRIO is 1.25 grams (imipenem 500 mg, cilastatin 500 mg, andrelebactam 250 mg) administered by intravenous (IV) infusion over 30 minutes every 6 hours in patients18 years of age and older with creatinine clearance (CLcr) of 90 mL/min or greater. A dose reduction isrecommended for patients with CLcr less than 90 mL/min (Table 1) [see Dosage and Administration (2.2)]. The severity and location of infection, as well as clinical response should guide the duration of
therapy. The recommended duration of treatment with RECARBRIO is 4 days to 14 days.
2.2 Dosage Adjustments in Patients with Renal Impairment
Dosage adjustment is recommended in patients with renal impairment. Patients who have a CLcr less
than 90 mL/min require dosage reduction of RECARBRIO (Table 1). For patients with fluctuating renal
function, CLcr should be monitored.
Table 1: Dosage of RECARBRIO for Adult Patients with Renal Impairment
Estimated CLcr (mL/min)a
Recommended Dosage of RECARBRIO
(imipenem/cilastatin and relebactam)
(mg)b
Dosing Interval
60 to 89 1 gram (imipenem 400 mg, cilastatin 400
mg, and relebactam 200 mg)
Every 6 hours
30 to 59 0.75 grams (imipenem 300 mg, cilastatin
300 mg, and relebactam 150 mg)
Every 6 hours
15 to 29 0.5 grams (imipenem 200 mg, cilastatin
200 mg, and relebactam 100 mg)
Every 6 hours
End Stage Renal Disease (ESRD)
on Hemodialysisc
0.5 grams (imipenem 200 mg, cilastatin
200 mg, and relebactam 100 mg)
Every 6 hours
aCLcr calculated using the Cockroft-Gault formula
bAdminister by IV over 30 minutes.
cAdministration should be timed to follow hemodialysis.
RECARBRIO is provided as a single vial in a fixed-dose combination; the dose for each component will be adjusted equallyduring preparation [see Dosage and Administration (2.4)].
Patients with CLcr less than 15 mL/m |
