imipenem anhydrous, cilastatin, and relebactam anhydrous

1 INDICATIONS AND USAGE RECARBRIO is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a beta-lactamase inhibitor, indicated in adult and pediatric patients weighing at least 2 kg for the treatment of the following infections caused by susceptible gram-negative microorganisms: Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP). ( 1.1 ) Complicated urinary tract infections, including pyelonephritis (cUTI) in patients who have limited or no alternative treatment options. ( 1.2 ) Complicated intra-abdominal infections (cIAI) in patients who have limited or no alternative treatment options. ( 1.3 ) Approval of the cUTI and cIAI indications is based on limited clinical safety and efficacy data for RECARBRIO. ( 1.2 , 1.3 , 14 ) Limitations of Use RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age). ( 1.4 , 2.2 ). RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment. ( 1.4 , 2.3 ). Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.5 ) 1.1 Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP) RECARBRIO ® is indicated in adult and pediatric patients weighing at least 2 kg for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia, caused by the following susceptible gram-negative microorganisms: Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae , Escherichia coli , Haemophilus influenzae , Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Serratia marcescens. 1.2 Complicated Urinary Tract Infections (cUTI), including Pyelonephritis RECARBRIO is indicated in adult and pediatric patients weighing at least 2 kg who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following susceptible gram-negative microorganisms: Enterobacter cloacae , Escherichia coli , Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa . Approval of this indication is based on limited clinical safety and efficacy data for RECARBRIO [see Clinical Studies (14.2) ] . 1.3 Complicated Intra-abdominal Infections (cIAI) RECARBRIO is indicated in adult and pediatric patients weighing at least 2 kg who have limited or no alternative treatment options for the treatment of complicated intra-abdominal infections (cIAI) caused by the following susceptible gram-negative microorganisms: Bacteroides caccae , Bacteroides fragilis , Bacteroides ovatus , Bacteroides stercoris , Bacteroides thetaiotaomicron , Bacteroides uniformis , Bacteroides vulgatus , Citrobacter freundii , Enterobacter cloacae , Escherichia coli , Fusobacterium nucleatum , 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 [see Clinical Studies (14.2) ] . 1.4 Limitations of Use RECARBRIO is not recommended in pediatric patients less than 37 weeks post-menstrual age (gestational age at birth plus post-natal age) [see Dosage and Administration (2.2) and Use in Specific Populations (8.4) ] . RECARBRIO is not recommended in pediatric patients weighing less than 30 kg with renal impairment [see Dosage and Administration (2.4) , Use in Specific Populations (8.4 , 8.6) and Clinical Pharmacology (12.3) ]. 1.5 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of RECARBRIO and other antibacterial drugs, RECARBRIO 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 are available, they 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.