Staquis Use In Pregnancy & Lactation

Pregnancy: There is a limited amount of data from the use of STAQUIS in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at maternally non-toxic doses (see Pharmacology: Toxicology: Preclinical safety data under Actions). Because animal reproduction studies are not always predictive of the human response, as a precautionary measure, the mother's clinical benefit of STAQUIS along with any potential risk on the fetus should be considered.
Breast-feeding: Animal studies on milk excretion after topical application were not conducted and the use of STAQUIS in breast-feeding women has not been studied. STAQUIS is systemically absorbed. It is unknown whether crisaborole/metabolites are excreted in human milk following topical application of STAQUIS or the effects of the medicinal product on the breastfed infant or on human milk production. The lack of clinical data during lactation precludes a clear determination of the risk of STAQUIS to a breastfed infant. Therefore, the developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for STAQUIS and any potential adverse effects on the breastfed infant from STAQUIS or from the underlying maternal condition.
To avoid unintentional ingestion by the newborn, STAQUIS should not be applied to the breast.
Fertility: Reproduction studies in male or female rats using oral administration of crisaborole revealed no effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).