Zytiga

Zytiga Use In Pregnancy & Lactation

abiraterone

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: ZYTIGA is contraindicated in women who are or may potentially be pregnant (see Contraindications).
There are no human data on the use of ZYTIGA in pregnancy and ZYTIGA is not for use in women of child-bearing potential. Maternal use of a CYP17 inhibitor is expected to produce changes in hormone levels that could affect development of the fetus (see Pharmacology: Pharmacodynamics: Mechanism of action and Toxicology: Non-Clinical Information: Reproductive Toxicology under Actions).
It is not known if 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.
To avoid inadvertent exposure, women who are pregnant or women who may be pregnant should not handle ZYTIGA 250 mg uncoated tablets without protection, e.g., gloves.
Breast-feeding: ZYTIGA is not for use in women.
It is not known if either abiraterone or its metabolites are excreted in human breast milk.
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