The US FDA approved Recarbrio (imipenem, cilastatin, and relebactam) for the treatment of complicated urinary tract and complicated intra-abdominal bacterial infections in adults who have limited therapeutic or no therapeutic alternatives available.
The targeted bacteria causing complicated urinary tract infections (cUTI) includes Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Bacteria causing intra-abdominal infections (iAI) include Bacteroides caccae, Bacteroides fragilis, Bacteroides ovatus, Bacteroides stercoris, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Fusobacterium nucleatum, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Parabacteroides distasonis, and Pseudomonas aeruginosa.
The drug is indicated for only susceptible bacteria but not the resistant bacteria.
The product has received Qualified Infectious Disease Product (QIDP) designation for the treatment of cUTI and cIAI. Recarbrio is expected to be available later this year.
The product is contraindicated in patients suffering from hypersensitivity