Posted from: Friday, August 09, 2019 - 03:10 PM - Present

Recarbrio Approved to Treat Complicated UTIs and Complicated IAIs

July 17, 2019 – The U.S. FDA has approved Recarbrio™ (imipenem, cilastatin, and relebactam), manufactured by Merck, for use in patients 18 years of age and older who have limited or no alternative treatment options for complicated urinary tract infections (cUTI) or complicated intra-abdominal infections (cIAI). The infections must be caused by or strongly suspected to be caused by susceptible gram-negative bacteria.

A three-drug combination injection, Recarbrio contains imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor that contributes to the efficacy of imipenem-cilastatin. Its approval is based in part on findings regarding the efficacy and safety of imipenem-cilastatin in treating cUTI and cIAI. The contribution of relebactam was assessed based on data from in vitro studies and animal models of infection. Two trials assessed the safety of Recarbrio, one for cUTI and one for cIAI.

Recommended dosing is 1.25g of Recarbrio administered via intravenous (IV) infusion over the course of 30 minutes every six hours in patients 18 years of age and older who have a creatinine clearance (CRcl) of 90mL/min or greater. The recommended duration of dosing is 4-14 days. Patients with a creatinine clearance less than 90mL/min, who have end stage renal disease, or who are undergoing hemodialysis require a modified dose depending on their individual circumstances.

Although Merck has not yet announced pricing information, the company has indicated it plans to launch Recarbrio in 2019.

Last Updated Tuesday, October 22, 2019 - 10:32 PM.