Urinary Tract

The antibacterial drug product Recarbrio (imipenem, cilastatin, and relebactam) has approve to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) in adults, the U.S. Food and Drug Administration announced. “The FDA remains focus on facilitating the development of safe; and effective new antibacterial drugs to give patients more options to fight serious infections,” said Ed Cox, M.D., M.P.H., director for the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

“It is important that the use of Recarbrio be reserved for situations when there are limited; or no alternative antibacterial drugs for treating a patient’s infection.”  Recarbrio, a three-drug combination injection, is intend to be use for patients who have limit; or no alternative antibacterial drugs to treat their infection, Ed Cox, M.D., M.P.H., director for the Office of Antimicrobial Products in the FDA Center for Drug Evaluation and Research, noted in an FDA release.

Antibacterial and antifungal drug

The recommended dose is 1.25 g administered by intravenous infusion; for 30 minutes every six hours in patients aged 18 years or older with creatinine clearance of at least 90 mL/minute. The most common adverse reactions observe in patients treat; with Recarbrio included nausea, diarrhea, headache; fever and increased liver enzymes. Recarbrio receive FDA’s Qualified Infectious Disease Product (QIDP) designation.

However, the QIDP designation is given to antibacterial and antifungal drug products intend; to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act. As part of QIDP designation; Recarbrio was grant Priority Review under which the FDA’s goal; is to take action on an application within an expedite time frame.

Recarbrio should not be use in patients taking ganciclovir unless the benefits; outweigh the risks as generalize seizures have reported. Patients should also avoid using Recarbrio when taking valproic acid or divalproex sodium; drugs used to manage seizures, as a reduction in valproic acid level may lead to seizures.

Complicated Urinary Tract

However, approval was partly based on data showing the efficacy and safety of imipenem-cilastatin; which has previously approved by the FDA, in treating cUTI and cIAI; as well as data from in vitro studies and animal models of infection evaluating the efficacy of relebactam. Two trials assessed the safety of Recarbrio: one study of 298 adults with cUTI, 99 of whom treat with the propose dose of Recarbrio; and one study of 347 adults with cIAI, 117 of whom treat with Recarbrio.

However, the most commonly report adverse reactions were nausea, diarrhea, headache; fever, and increased liver enzymes. The FDA notes that Recarbrio is not indicate for patients taking ganciclovir because generalize; seizures report in this population. However, Recarbrio use should also avoid for patients taking valproic acid or divalproex sodium.