Sirolimus

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

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.

Alternate Drugs to Consider

Azathioprine, Cyclosporine, Tacrolimus

References

1.

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 Name

Sirolimus

CAS Registry Number

53123-88-9

Drug Class

Breast Feeding

Lactation

Milk, Human

Immunosuppressive Agents