Abiraterone

Abiraterone Acetate

Pregnancy

Abiraterone is not for use in women and is contraindicated in women who are or may potentially be pregnant.

Nursing Mothers

Abiraterone is not for use in women.

Carcinogenesis, Mutagenesis and Fertility

Women of childbearing potential

There are no human data on the use of abiraterone 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.

Fertility

Abiraterone affected fertility in male and female rats, but these effects were fully reversible.

Effects on Ability to Drive and Use Machines

Abiraterone has no or negligible influence on the ability to drive and use machines.