FRIDAY, June 5, 2020 (HealthDay News) -- The U.S. Food and Drug Administration granted approval to Recarbrio (combination of imipenem-cilastatin and relebactam) for treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), the agency announced Thursday.
Recarbrio was approved last year for treatment of complicated urinary tract infections and complicated intra-abdominal infections.
The most recent approval of Recarbrio was based on data from a randomized, controlled trial of 535 patients hospitalized with HABP/VABP due to gram-negative bacteria randomly assigned to treatment with Recarbrio (266 patients) or piperacillin-tazobactam (269 patients). At day 28 of the study, 16 and 21 percent of patients treated with Recarbrio and piperacillin-tazobactam, respectively, had died.
The most commonly reported adverse reactions included increased aspartate/alanine aminotransferases, anemia, diarrhea, hypokalemia, and hyponatremia. Health care professionals should ask patients about previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens before initiating treatment. Recarbrio is contraindicated in patients prone to seizures and other central nervous system disorders.
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