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Women of childbearing potential: There are no human data on the use of abiraterone acetate tablets in pregnancy and this medicinal product is not for use in women of childbearing potential.
Contraception in males and females: It is not known whether abiraterone or its metabolites are present in semen. A condom is required if the patient is engaged in sexual activity with a pregnant woman. If the patient is engaged in sex with a woman of childbearing potential, a condom is required along with another effective contraceptive method. Studies in animals have shown reproductive toxicity.
Pregnancy: Abiraterone acetate tablets are not for use in women and is contraindicated in women who are or may potentially be pregnant (see Contraindications). To avoid inadvertent exposure, women who are pregnant or women who may be pregnant should not handle ARTESTO without protection, e.g., gloves.
Fertility: Abiraterone affected fertility in male and female rats, but these effects were fully reversible.
Breast-feeding: Abiraterone acetate tablets are not for use in women.
