Summary of Use during Lactation

Topical pimecrolimus has not been studied during breastfeeding; however, it is used topically in children as young as 3 months of age. Because it is poorly absorbed after topical application and plasma concentrations after topical use in adults are less than 2 mcg/L, it is a low risk to the nursing infant. Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Older recommendations state that if the breast is to be treated, an alternate drug is preferred; do not apply to the nipple area while nursing.[1,2] A newer European guideline allows pimecrolimus to be applied just after nursing, with the nipples cleaned gently and carefully before nursing.[3] Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[4]

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Tacrolimus

References

1.

Barrett ME, Heller MM, Fullerton Stone H, et al. Dermatoses of the breast in lactation. Dermatol Ther. 2013;26:331–6. [PubMed: 23914890]

2.

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70:417.e1–10. [PubMed: 24528912]

3.

Vestergaard C, Wollenberg A, Barbarot S, et al. European task force on atopic dermatitis position paper: treatment of parental atopic dermatitis during preconception, pregnancy and lactation period. J Eur Acad Dermatol Venereol. 2019;33:1644–59. [PubMed: 31231864]

4.

Noti A, Grob K, Biedermann M, et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317–25. [PubMed: 14623482]

Substance Name

Pimecrolimus

CAS Registry Number

137071-32-0

Drug Class

Breast Feeding

Lactation

Anti-Inflammatory Agents, Non-Steroidal

Dermatologic Agents

Immunosuppressive Agents