The FDA has approved a new antimicrobial combination to treat adults with complicated intra-abdominal infections and complicated urinary tract infections (UTIs), the agency announced on July 17.
The three-drug combination injection (Recarbrio) contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor. Efficacy of the treatment was supported in part by data on the efficacy and safety of imipenem-cilastatin to treat complicated intra-abdominal infections and complicated UTIs, and the contribution of relebactam was assessed based on data from in vitro studies and animal models of infection.
Safety of the combination treatment was studied in two trials, one each for complicated intra-abdominal infections and complicated UTIs. The most common adverse reactions were nausea, diarrhea, headache, fever, and increased liver enzymes. The drug should not be used in patients taking ganciclovir unless the benefits outweigh the risks, as generalized seizures have been reported. In addition, clinicians should avoid use in patients taking valproic acid or divalproex sodium, as a reduction in valproic acid level may lead to seizures.