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Everolimus Pregnancy and Breastfeeding Warnings

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

Everolimus Pregnancy Warnings

Animal studies showed embryo-fetal and maternal toxicities at exposures lower than expected in humans at a dose of 10 mg daily. Toxicities included increased resorption, pre-implantation and post-implantation loss, decreased number of live fetuses, malformation, and retarded skeletal development. There are no controlled data in human pregnancy. In animal studies, testicular morphology was affected at exposures within the clinical range. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended. AU TGA pregnancy category: C US FDA pregnancy category: -Afinitor(R): D -Zortress(R): C Comments: Encourage use of adequate methods of contraception during treatment and for up to 8 weeks following the last dose.

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.

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