Summary of use during lactation
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 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
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] A review of the Transplant Pregnancy Registry International database from 1999 to 2024 found that 4 mothers with transplants had breastfed their infants for at least 4 weeks while taking sirolimus.[2]
Effects on lactation and breastmilk
Relevant published information was not found as of the revision date.
Alternative drugs to consider
Azathioprine, Cyclosporine, Tacrolimus
Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.
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