There is limited information regarding the acute toxicity and overdose of cipaglucosidase alfa. No doses of cipaglucosidase alfa greater than 20 mg/kg body weight have been studied.^L46721

Based on findings from animal reproduction studies, cipaglucosidase alfa in combination with Opfolda may cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy. In a rabbit embryo-fetal development study, great vessel and cardiac malformations were increased in the offspring of pregnant rabbits treated with cipaglucosidase alfa in combination with miglustat at 16-fold and 3-fold, respectively, the maximum recommended human dose (MRHD) of cipaglucosidase alfa and Opfolda based on plasma AUC exposure. A No Observed Adverse Effect Level (NOAEL) was not identified for the combination. In a pre-and post-natal development study in rats, increases in pup mortality were seen following maternal treatment with cipaglucosidase alfa (400 mg/kg) in combination with miglustat, or with cipaglucosidase alfa (400 mg/kg) alone. The NOAEL for cipaglucosidase alfa-atga alone is 150 mg/kg (5-fold the cipaglucosidase alfa MRHD margin). A NOAEL for the combination was not identified. Margins at the lowest observed adverse effect level (LOAEL), relative to exposures at the MRHD of cipaglucosidase alfa and Opfolda were 21- and 4-fold, respectively, based on plasma AUC exposure.^L49236

Studies in animals to evaluate the carcinogenic, mutagenic, or genotoxic potential of cipaglucosidase alfa have not been conducted.^L49236