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There are no adequate data from the use of Certican in pregnant women. Studies in animals have shown reproductive toxicity effects including embryo/foetotoxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). The potential risk for humans is unknown. Certican should not be given to pregnant women unless the potential benefit outweighs the potential risk for the foetus. Women of childbearing potential should be advised to use effective contraception methods while they are receiving Certican and up to 8 weeks after treatment has been stopped.
It is not known whether everolimus is excreted in human milk. In animal studies, everolimus and/or its metabolites were readily transferred into milk of lactating rats. Therefore women who are taking Certican should not breast feed.
