Roflumilast and Breastfeeding

Summary of use during lactation

No information is available on the use of roflumilast in nursing mothers. The drug and its metabolite are more than 97% bound to plasma proteins, so amounts in milk are likely to be very low. However, the manufacturer and some experts recommend that the oral drug should not be used by women who are nursing.[1] Topical products are unlikely to affect the infant but should be applied to the smallest area of skin and for the shortest duration possible while breastfeeding. To avoid direct infant exposure, do not apply roflumilast directly to the nipple or areola. If applied to the patient's chest, avoid exposure via direct contact with the infant's skin.

Drug levels in milk and infant serum

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.

References

1. Yaghi M, McMullan P, Truong TM, et al. Safety of dermatologic medications in pregnancy and lactation: An Update - Part II: Lactation. J Am Acad Dermatol 2024;91:651-68.38280680 PubMed