Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females
It is not known whether components of Akeega or their metabolites are present in semen.

During treatment and for four months after the last dose of Akeega:
•     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 (see section 5.3).

Pregnancy
Akeega is not for use in women (see section 4.3).

There are no data from the use of Akeega in pregnant women. Akeega has the potential to cause foetal harm based on the mechanism of action of both components and findings from animal studies with abiraterone acetate. Animal developmental and reproductive toxicology studies were not conducted with niraparib (see section 5.3).

Akeega-50/500_mg_100/500_mg_Film Coated Tablets_PI_09_2024

Breast-feeding
Akeega is not for use in women.
Fertility
There are no clinical data on fertility with Akeega. In animal studies, male fertility was reduced with niraparib or abiraterone acetate but these effects were reversible following treatment cessation (see section 5.3).