The FDA today approved Recarbrio, an antibiotic injection containing a combination of imipenem-cilastatin and relebactam, a new beta-lactamase inhibitor, to treat complicated urinary tract infections (UTI) including pyelonephritis, and complicated intra-abdominal infections (IAI).

The drug treats UTI infections caused by Gram-negative microorganisms including Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa. It also treats IAI infections caused by 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.

Recarbrio, produced by Merck & Co Inc, was evaluated in 2 separate trials of 298 UTI and 347 IAI patients. The most common adverse reactions were nausea, diarrhea, headache, fever, and increased liver enzymes.

According to an FDA statement, Recarbrio should not be used in patients taking ganciclovir due to the risk for generalized seizures, unless the benefits outweigh the risks. Also, clinicians should avoid prescribing Recarbrio to patients taking valproic acid or divalproex sodium, which are used to treat seizures.

Recarbrio has received FDA’s Qualified Infectious Disease Product (QIDP) designation because it treats serious and life-threatening infections.

“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,” Ed Cox, MD, MPH, of the Center for Drug Evaluation and Research, emphasized in the FDA release.

References

FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections [news release]. Silver Spring, MD. US Food and Drug Administration; Jul 17, 2019.

FDA Approves Merck’s RECARBRIO™ (imipenem, cilastatin, and relebactam) For the Treatment of Adults with Complicated Urinary Tract and Complicated Intra-Abdominal Bacterial Infections Where Limited or No Alternative Treatment Options Are Available [news release]. Merck & Co., July 17, 2019.