Everolimus Pregnancy and Breastfeeding Warnings
Everolimus Pregnancy Warnings
Based on the mechanism of action of everolimus, the drug may cause fetal harm when administered to a pregnant woman.
Everolimus has been assigned to pregnancy category D by the FDA when marketed under the brand name Afinitor(R) and assigned to pregnancy category C by the FDA when marketed under the brand name Zortress(R). Animal studies have revealed evidence of embryofetotoxicity. There are no controlled data in human pregnancy. Everolimus should only be used during pregnancy when the potential benefits outweigh the potential risks to the developing foetus. If everolimus is used during pregnancy or if the patient becomes pregnant during treatment, the patient should be advised of the potential hazard to the developing foetus. Women of childbearing potential should be encouraged to use adequate methods of contraception during administration of everolimus and for up to 8 weeks after treatment has been discontinued.
Everolimus Breastfeeding Warnings
There are no data on the excretion of everolimus into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants from everolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
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