The Basics
What is Everolimus?
Used as an immunosuppressant to prevent rejection of organ transplants and in the treatment of renal cell cancer and other tumors.
Brand names for Everolimus
Zortress
How Everolimus is classified
Immunosuppressive Agents
Everolimus During Pregnancy
Everolimus pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Everolimus while pregnant
Based on animal studies and the mechanism of action [see CLINICAL PHARMACOLOGY], Zortress can cause fetal harm when administered to a pregnant woman. There are limited case reports of Zortress use in pregnant women; however, these reports are insufficient to inform a drug associated risk of adverse developmental outcomes. Reproductive studies in animals have demonstrated that everolimus was maternally toxic in rabbits, and caused embryo-fetal toxicities in rats and rabbits, at exposures near or below those achieved in human transplant patients. Advise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies.
Taking Everolimus While Breastfeeding
What are recommendations for lactation if you're taking Everolimus?
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.
Maternal / infant drug levels
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.
Possible effects of Everolimus on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Everolimus
Azathioprine, Cyclosporine, Tacrolimus.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. 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. PMID: 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. PMID: 29255138
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
