Zevtera: genotox, carcinogenicity and repro: done or skipped?

“However, in vivo ceftobiprole medocaril sodium was negative in both the micronucleus assay and rat liver unscheduled DNA synthesis reducing concern for potential clastogenic activity.”

“No studies were available and none are warranted for this relatively short treatment duration.”

“Intravenous administration of ceftobiprole medocaril sodium to pregnant rats and monkeys during organogenesis showed no evidence of adverse fetal developmental outcomes at doses approximately 1.4 times and 0.9 times the MRHD, respectively, based on BSA comparison.”

“Ro 63-9141-induced convulsion appears to be a primary effect and not secondary to kidney damage as convulsions were seen with direct injection into the brain.”