Elidel Use In Pregnancy & Lactation

Use in Pregnancy: There are no adequate data from the use of Elidel 1% cream in pregnant women. Animal studies using dermal application do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions).
Caution should be exercised when prescribing Elidel 1% cream to pregnant women. However, based on the minimal extent of pimecrolimus absorption after topical application of Elidel 1% cream (see Pharmacology: PHARMACOKINETICS under Actions), the potential risk for humans is considered limited.
Use in Lactation: Animal studies on milk excretion after topical application were not conducted. It is not known whether pimecrolimus is excreted in the milk after topical application. Because many drugs are excreted in human milk, caution should be exercised when Elidel 1% cream is administered to a nursing woman. However, based on the minimal extent of pimecrolimus absorption after topical application of Elidel 1% cream, (see Pharmacology: PHARMACOKINETICS under Actions), the potential risk for humans is considered limited.
Nursing mothers should not apply Elidel 1% cream to the breast.
Fertility: There are no clinical data on the effects of pimecrolimus on male or female fertility (see Pharmacology: Toxicology: PRECLINICAL SAFETY DATA under Actions).