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Pregnancy: Risk Summary: The safety of Exelon in human pregnancy has not been established. In pregnant animals, rivastigmine and/or metabolites crossed the placenta. It is not known if this occurs in humans. In animal studies, rivastigmine was not teratogenic. Exelon should only be given to pregnant women if the potential benefit outweighs the potential risk for the fetus.
Animal data: Embryo-fetal toxicity studies in pregnant rats and rabbits with oral dose levels up to 2.3 mg base/kg/day revealed no evidence of teratogenic potential for rivastigmine. In pre- and post-natal studies, there was no evidence of adverse effects of rivastigmine on fertility, reproductive performance or in utero or postnatal growth and development in rats at dose levels up to 1.1 mg base/kg/day. Specific dermal studies in pregnant animals have not been conducted.
Lactation: It is not known if Exelon is transferred into human milk. In animals, rivastigmine and/or metabolites were transferred in breast milk. Patients on Exelon should therefore not breast-feed.
Females and males of reproductive potential: There is no information available on the effects of rivastigmine in women of child-bearing potential.
Infertility: There is no information available on the effects of rivastigmine on human fertility. In male and female rats, no adverse effects of rivastigmine were observed on fertility or reproductive performance of either the parent generation or the offspring of the parents.
