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

“Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.”

“No long-term animal studies have been performed to establish the carcinogenicity potential of tocilizumab.”

“Although there was no evidence for a teratogenic/dysmorphogenic effect at any dose, tocilizumab produced an increase in the incidence of abortion/embryo-fetal death at doses 1.25 times and higher the MRHD by the intravenous route at maternal intravenous doses of 10 and 50 mg/ kg.”

“Tocilizumab showed no effect on the cardiac electrophysiological performance, cardiac tissue integrity or systemic pro-thrombotic activities IV at doses up to 50 mg/kg.”