WASHINGTON — The FDA approved the drug combo imipenem-cilastatin and relebactam (Recarbrio) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older.
The intravenous drug was found safe and effective for the treatment of HABP/VABP in a “randomized controlled clinical trial of 535 hospitalized adults with HABP/VABP due gram-negative bacteria (a type of bacteria) in which 266 patients were treated with [imipenem-cilastatin and relebactam] and 269 patients were treated with piperacillin-tazobactam, another antibacterial drug,” the FDA explained in a press release. “Overall, 16% of patients who received [imipenem-cilastatin and relebactam] and 21% of patients who received piperacillin-tazobactam died through Day 28 of the study.”
Aspartate/alanine aminotransferase, anemia, diarrhea, and hypokalemia and hyponatremia were the most common adverse side effects associated with the treatment. However, the agency cautioned that clinicians should query their patients on previous “hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens.”
The drug combo should also not be used in patients prone to seizures or other nervous system disorders. In addition, imipenem-cilastatin and relebactam, like other antibacteral agents, can cause Clostridioides difficile, which “may range in severity from mild diarrhea to fatal colitis,” the FDA warned.
The application for imipenem-cilastatin and relebactam was granted Qualified Infectious Disease Program (QUDP) designation, and was also granted Fast Track and Priority Review.
Imipenem-cilastatin and relebactam was previously approved for the treatment of complicated urinary tract infections and complicated intra-abdominal infections, for which there are limited or no alternative treatments.
Candace Hoffmann, Managing Editor, BreakingMED™
Cat ID: 469
Topic ID: 79,469,500,503,791,730,469,520,192,925
