Use in Pregnancy: There are no adequate data from the use of Certican in pregnant women. Studies in animals have shown reproductive toxicity effects, including embryo/fetotoxicity (see Toxicology under Actions). The potential risk to humans is unknown. Certican should not be given to pregnant women, unless the potential benefit outweighs the potential risk to the fetus. Women of childbearing potential should be advised to use effective contraception methods while they are receiving Certican, and for up to 8 weeks after ending treatment.
Use in Lactation: It is not known whether everolimus is excreted in breastmilk, but in animal studies, everolimus and/or its metabolites readily passed into the milk of lactating rats. Women taking Certican should therefore, not breastfeed.