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Everolimus Pregnancy and Breastfeeding Warnings

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

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. 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 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 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: -Afinitor(R): Not assigned -Zortress(R): C Comments: Encourage use of adequate methods of contraception during treatment and for up to 8 weeks following the last dose. Risk Summary: Based on animal studies and the mechanism of action, this drug can cause fetal harm when administered to a pregnant woman.

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.

See references

References for pregnancy information

  1. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.
  2. "Product Information. Zortress (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Zortress (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.
  4. "Product Information. Afinitor (everolimus)." Novartis Pharmaceuticals, East Hanover, NJ.

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