Biapenem use in pediatric patients: current state of knowledge

Abstract

Biapenem, in combination with polymyxin and/or tigecycline, has promising potential in the treatment of severe infections in children, including infections caused by some difficult to treat resistant pathogens. However, biapenem is currently approved only for adult use, and its administration in pediatrics remains off-label. Available literature on pediatric use of biapenem predominantly dates back to the 1990s. There is a lack of data in Russian-language scientific literature regarding the use of biapenem in pediatric practice. This review is the first publication in Russian to systematize biapenem key pharmacokinetic and pharmacodynamic parameters, evaluate its potential for treating infections caused by resistant pathogens, describe optimal dosing regimens for children, and analyze its safety profile, including a comparison with data obtained from treating adults. Available pharmacokinetic data in children do not differ significantly from those in adults (Cmax of 24–65 mg/L, T1/2 of 1 hour), however, the volume of distribution, age-related metabolic changes, and dose adjustments for renal impairment in children remain uninvestigated. The most frequently reported dosing regimen in the literature is 6–12 mg/kg per dose or 15–30 mg/kg/day, whereas for the treatment of meningitis, doses of up to 40 mg/kg every 6 hours have been utilized. The drug demonstrates favorable tolerability and a lower incidence of adverse events compared to imipenem, with particular emphasis on its minimal neurotoxic potential relative to other carbapenems. Gaps in pharmacokinetic data for the pediatric population, the lack of reported cases of biapenem therapy for multidrug-resistant pathogens in children, and unresolved questions regarding dose adjustments in the context of rising resistance and altered pharmacokinetics in critically ill patients highlight the urgent need for modern prospective pharmacokinetic and clinical studies in children.