FDA Approves Combo Drug for Complicated UTIs, Intra-Abdominal Infections

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

The FDA has approved a three-drug combination (marketed as Recarbrio) to treat complicated urinary tract infections and complicated intra-abdominal infections in adults.

Imipenem-cilastatin is a previously approved antibiotic, and relebactam is a new beta-lactamase inhibitor.

The agency notes that the drug should "be reserved" for patients for whom other treatments don't work. Additionally, due to a risk for central nervous reactions, patients taking Recarbrio should avoid concomitant use with antiseizure drugs (e.g., valproic acid or divalproex sodium). Diarrhea, elevated liver enzymes, fever, headache, and nausea are among the most commonly experienced side effects.

Approval for the drug, which is given by injection, was based on data from imipenem-cilastatin studies, in vitro studies and animal models for relebactam, and two trials in which patients were given the combination.