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Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-.

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Drugs and Lactation Database (LactMed) [Internet].

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Everolimus

Last Revision: October 23, 2019.

Estimated reading time: 1 minute

CASRN: 159351-69-6

image 135156085 in the ncbi pubchem database

Drug Levels and Effects

Summary of Use during Lactation

In one patient, everolimus was not detected in the colostrum of a mother taking everolimus; however, no information is available on the use of everolimus during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. A woman was receiving everolimus 2 mg daily and cyclosporine 1.5 mg/kg daily during pregnancy and postpartum following a heart transplant. Although she did not breastfeed, a colostrum sample was obtained one day postpartum which contained undetectable everolimus levels (<0.5 mcg/L). The timing of the sample with respect to the previous everolimus dose was not stated. Measurement of serial plasma levels of everolimus obtained transplacentally found the estimated elimination half-life of everolimus to be about 86 hours in the newborn.[1]

A woman with a kidney transplant received azathioprine 125 mg, methylprednisolone12 mg, and everolimus 0.5 mg daily during pregnancy and postpartum. On the second day postpartum, 6 colostrum samples were collected. The pre-dose level was 33 ng/L. The highest level was 66 ng/L at 4 hours after the dose. Samples taken at 2, 6, 8 and 12 hours after the dose contained concentrations that ranged from 45 to 51 ng/L.[2]

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

Azathioprine, Cyclosporine, Tacrolimus

References

1.
Fiocchi R, D'Elia E, Vittori C, et al. First report of a successful pregnancy in an everolimus-treated heart-transplanted patient: Neonatal disappearance of immunosuppressive drugs. Am J Transplant. 2016;16:1319–22. [PubMed: 26555407]
2.
Kociszewska-Najman B, Szpotanska-Sikorska M, Mazanowska N, et al. Transfer of everolimus into colostrum of a kidney transplant mother. Ann Transplant. 2017;22:755–8. [PMC free article: PMC6248263] [PubMed: 29255138]

Substance Identification

Substance Name

Everolimus

CAS Registry Number

159351-69-6

Drug Class

Breast Feeding

Lactation

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.

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