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Abiraterone Pregnancy and Breastfeeding Warnings

Abiraterone is also known as: Zytiga

Abiraterone Pregnancy Warnings

-This drug can cause fetal harm based on its mechanism of action and animal studies. -It is not indicated for use in women, and is contraindicated in women who are or may become pregnant. AU TGA pregnancy category: D US FDA pregnancy category: X Comments: -Females of reproductive potential should be advised to avoid becoming pregnant during treatment, and apprised of the potential hazard to the fetus and the potential risk for pregnancy loss if pregnancy occurs while taking this drug. -Male patients should be advised to use a condom and another effective method of birth control during treatment and for one week following treatment cessation if having sex with a pregnant woman or a woman of child-bearing potential as it is unknown whether this drug or its metabolites are present in semen.

Animal studies revealed evidence of developmental toxicity at systemic exposures that were lower than in patients receiving the recommended human dose. Findings included embryofetal lethality, fetal developmental delay, decreased fetal body weight, urogenital effects, and maternal toxicity. Animal studies also showed this drug has potential to impair reproductive function and fertility in humans. Observed effects include atrophy, aspermia/hypospermia, reduced organ weights of the reproductive system, altered sperm morphology, and decreased fertility in males; increased pre-implantation loss and reduced number of corpora lutea, implantations, and live embryos in females. Fertility effects were reversible in female animals after 4 weeks and in male animals after 16 weeks from the last drug dose. There are no controlled data in human pregnancy. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. US FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

See references

Abiraterone Breastfeeding Warnings

This drug is not indicated for use in women. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Zytiga (abiraterone)." Centocor Inc, Malvern, PA.

References for breastfeeding information

  1. "Product Information. Zytiga (abiraterone)." Centocor Inc, Malvern, PA.

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