Skip to Content

Everolimus Pregnancy and Breastfeeding Warnings

Everolimus is also known as: Afinitor, Afinitor Disperz, Zortress

Medically reviewed on February 12, 2018

Everolimus Pregnancy Warnings

Animal studies showed embryofetal and maternal toxicities at exposures lower than expected in humans at a dose of 10 mg daily. Toxicities included increased resorption, preimplantation and postimplantation loss, decreased number of live fetuses, malformation, and retarded skeletal development. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is not recommended.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk Summary: Based on animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

Comments:
-Encourage use of adequate methods of contraception during therapy
and for up to 8 weeks following the last dose.
-This drug may impair fertility in males based on human and animal findings.

See references

Everolimus Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Animal studies have shown that this drug and/or its metabolites pass readily into milk; the concentration in the milk was 3.5 times greater than the maternal serum.
-Advise women not to breastfeed during therapy and for 2 weeks after the last dose.

No information is available on the use of this drug during breastfeeding. An alternate drug may be preferred, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide