The Food and Drug Administration (FDA) has approved Recarbrio (imipenem, cilastatin, relebactam; Merck) for the treatment of adult patients aged 18 years and older with complicated urinary tract infections (cUTI), including pyelonephritis, and for the treatment of complicated intra-abdominal infections (cIAI).
Recarbrio is a combination of imipenem, a penem antibacterial, cilastatin, a renal dehydropeptidase inhibitor, and relebactam, a new beta-lactamase inhibitor. It should only be used to treat or prevent infections in patients who have limited or no alternative treatment options.
Specifically, the treatment is indicated for cUTI including pyelonephritis caused by the following susceptible Gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa. For cIAI, Recarbrio is effective against the following Gram-negative pathogens: Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, E. coli, Fusobacterium nucleatum, K. aerogenes, K. oxytoca, K. pneumoniae, Parabacteroides distasonis and P. aeruginosa.
The approval was supported by the efficacy and safety data of imipenem-cilastatin for the treatment of cUTI and cIAI; relebactam was assessed based on data from in vitro studies and animal models of infection. Moreover, safety studies of Recarbrio were conducted in 2 trials, one each for cUTI (N=298) and cIAI (N=347). The most common adverse reactions reported were diarrhea, nausea, headache, vomiting, increased alanine aminotransferase, increased aspartate aminotransferase, phlebitis/infusion site reactions, pyrexia, and hypertension.
“The FDA remains focused on facilitating the development of safe and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, MD, MPH, director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research. “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection.”
Recarbio will be supplied as 1.25g sterile powder for constitution in single-dose vial containing imipenem 500mg, cilastatin 500mg, and relebactam 250mg. The product is expected to be available in late 2019.
For more information visit merck.com.