Daclizumab did not affect reproductive capacity in female and male cynomolgus monkeys (AUC in females and males up to 85 and 100 times higher than the exposure at the clinical dose respectively). There was no effect on foetal development and no evidence of teratogenicity. Daclizumab had no effect on peri- and post-natal development from birth to up to 6 months in the offspring. Exposures (AUC) in these studies ranged from 55 to 140 times that observed with the clinical dose. Daclizumab was detected in the milk of 11/14 lactating monkeys at levels that were <% of the maternal serum levels, with no adverse reactions observed in the off-spring.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention. Also contemplated are any values that fall within the cited ranges.