Abiraterone Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.
Risk Summary: Based on findings from animal studies and its mechanism of action, this drug is contraindicated for use in pregnancy because the drug can cause fetal harm and potential loss of pregnancy.
Comments:
-This drug can cause fetal harm based on its mechanism of action and animal studies.
-This drug is not indicated for use in female patients.
-Based on animal studies, this drug may impair reproductive function and fertility in males of reproductive potential.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 3 weeks after.
-Females who are or may become pregnant should not handle this drug if broken, crushed, or damaged without protection (e.g., gloves).
Animal studies revealed evidence of developmental toxicity at systemic exposures that were lower than the equivalent human dose. Findings included embryofetal lethality, fetal developmental delay, decreased fetal body weight, urogenital effects, and maternal toxicity. Animal studies also showed impairment of 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 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.
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