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Women of child-bearing potential (and contraceptive measures): 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.
Pregnancy: There are no adequate data from the use of Certican in pregnant women. Studies in animals have shown reproductive toxicity effects including embryotoxicity and fetotoxicity (see Pharmacology: Toxicology: Nonclinical safety data 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.
Breast feeding: It is not known whether everolimus is excreted in breast milk, but in animal studies, everolimus and/or its metabolites readily passed into the milk of lactating rats. Women taking Certican should therefore not breast feed.
Fertility: There are literature reports of reversible azoospermia and oligospermia in patients treated with mTOR inhibitors (see Precautions and Pharmacology: Toxicology: Nonclinical safety data under Actions).
