Certican Use In Pregnancy & Lactation

Pregnancy: Risk Summary: 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. 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.
Animal Data: In rats, everolimus crossed the placenta and was toxic to the conceptus. Everolimus caused embryo/fetotoxicity that was manifested as mortality, reduced fetal weight, and an increased incidence of skeletal variations and malformations at systemic exposures below the target therapeutic exposure in humans. In rabbits, embryotoxicity was evident by an increase in late resorptions at systemic exposures similar to those in humans.
Lactation: 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.
Females and males of reproductive potential: Contraception: Females of reproductive potential should be advised to use highly effective contraception methods while they are receiving Certican and for up to 8 weeks after ending treatment.
Infertility: There are literature reports of reversible azoospermia and oligospermia in patients treated with mTOR inhibitors (see PRECAUTIONS and Pharmacology: Toxicology: NON-CLINICAL SAFETY DATA under Actions).
In rat studies, female fertility was not affected.