The FDA has approved Recarbrio (imipenem, cilastatin, and relebactam) for injection, an antibacterial drug product to treat adults with complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs).
The three-drug-combination injection, by Merck & Co., contains imipenem–cilastatin, an antibiotic previously approved by the FDA, and relebactam, a new beta-lactamase inhibitor.
Efficacy was partly supported by the safety and efficacy findings of imipenem–cilastatin for cUTI and cIAI treatment. Relebactam’s contribution to Recarbrio was assessed based on data from in vitro studies and animal models of infection. The safety of the drug combination was studied in two separate trials for cUTI and cIAI: the cUTI trial included 298 adult patients, 99 of whom were treated with imipenem, cilastatin, and relebactam. The cIAI trial included 347 patients, 117 of whom received imipenem, cilastatin, and relebactam.
The most common adverse reactions observed in patients treated with the drug combination included nausea, diarrhea, headache, fever, and increased liver enzymes.
Imipenem, cilastatin, and relebactam should not be used in patients taking ganciclovir unless the benefits outweigh the risks, as generalized seizures have been reported.
Recarbrio received qualified infectious disease product (QIDP) and priority review designations.
Source: FDA, July 17, 2019