FDA Approves Imipenem-Cilastatin/Relebactam (Recarbrio) for Bacterial Pneumonia

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and André Sofair, MD, MPH

The FDA has approved the three-drug combination imipenem-cilastatin/relebactam (Recarbrio) for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adults. The drug was previously approved to treat complicated urinary tract infections and complicated intra-abdominal infections.

Approval was based on a randomized, controlled trial of over 500 patients hospitalized with hospital-acquired or ventilator-associated bacteria pneumonia. Patients given imipenem-cilastatin/relebactam had a lower mortality rate after 28 days, compared with those who received a piperacillin-tazobactam (16% vs. 21%).

The drug is associated with increased risk for Clostridioides difficile-associated diarrhea and central nervous reactions. The most commonly experienced side effects include anemia, diarrhea, elevated liver enzymes, low potassium, and low sodium.