Because almost no information is available on the use of oral sirolimus during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Sirolimus is undetectable in the bloodstream after application to the skin, so use of topical sirolimus is unlikely to affect a nursing infant. Avoid application to the nipple area and ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated.
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
One infant was reported breastfed (extent not stated) during maternal therapy with sirolimus, tacrolimus and prednisone in unspecified dosages following a kidney-pancreas transplant. The authors who followed the mother knew of no serious side effects in the infant.[1]
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Bramham K, Chusney G, Lee J, et al. Breastfeeding and tacrolimus: Serial monitoring in breast-fed and bottle-fed infants. Clin J Am Soc Nephrol 2013;8:563-7 [PMC free article: PMC3613954] [PubMed: 23349333]
Substance Identification
Substance Name
Sirolimus
CAS Registry Number
53123-88-9
Drug Class
Breast Feeding
Lactation
Milk, Human
Immunosuppressive Agents
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.
