Elidel Use In Pregnancy & Lactation

Pregnancy: There are no adequate data from the use of Elidel in pregnant women. Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to embryonal/fetal development. Studies in animals after oral application have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). Based on the minimal extent of pimecrolimus absorption after topical application of pimecrolimus (see Pharmacology: Pharmacokinetics under Actions), the potential risk for humans is considered limited. However, pimecrolimus should not be used during pregnancy.
Lactation: Animal studies on milk excretion after topical application were not conducted and the use of Elidel in breastfeeding women has not been studied. It is not known whether pimecrolimus is excreted in the milk after topical application.
However, based on the minimal extent of pimecrolimus absorption after topical application of Elidel (see Pharmacology: Pharmacokinetics under Actions), the potential risk for humans is considered limited. Caution should be exercised when pimecrolimus is administered to breastfeeding women.
Breastfeeding mothers may use Elidel but should not apply Elidel to the breast in order to avoid unintentional oral uptake by the newborn.
Fertility: There are no clinical data on the effects of pimecrolimus on male or female fertility (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).