SUMMARY

• There are no clinical data regarding fertility with AKEEGA. Fertility studies in female and male rats showed that abiraterone acetate reduced fertility in a manner that was reversible in 4 and 16 weeks from the last administration, respectively.¹
• It is not known whether the components of AKEEGA or their metabolites are present in semen. Animal studies have shown reproductive toxicity with AKEEGA. During treatment with AKEEGA and for 4 months after the last dose, males with female partners of reproductive potential should use effective contraception.¹
• There are no clinical data regarding the use of AKEEGA in pregnant females. Based on the mechanism of action and animal studies, AKEEGA has the potential to cause fetal harm and loss of pregnancy when administered to a pregnant female. A developmental toxicity study in rats showed that the effects of abiraterone acetate on pregnancy included reduced fetal weight and survival.¹

IN-VITRO/NONCLINICAL AND CLINICAL DATA

Fertility

• There are no clinical data regarding fertility with AKEEGA.¹
• In fertility studies in both female and male rats, abiraterone acetate reduced fertility in a manner that was reversible in 4 and 16 weeks from the last administration, respectively.¹
• In these fertility studies performed in rats, all effects were related to the pharmacological activity of abiraterone.¹

Reproductive Potential

• It is not known whether the components of AKEEGA or their metabolites are present in semen.¹
• Studies in animals have shown reproductive toxicity.¹
• During treatment with AKEEGA and for 4 months after the last dose, males with female partners of reproductive potential should use effective contraception.¹

Pregnancy

• The safety and efficacy of AKEEGA has not been established in females.¹
• There are no clinical data regarding the use of AKEEGA in pregnant females. AKEEGA has the potential to cause fetal harm based on the mechanism of action of both niraparib and abiraterone acetate and findings from animal studies with abiraterone acetate.¹
• Females who are or may become pregnant should handle AKEEGA tablets with protection, eg, gloves.¹
• Reproductive and developmental toxicity studies have not been conducted with niraparib.¹
• In a developmental toxicity study in rats, the effects of abiraterone acetate on pregnancy included reduced fetal weight and survival.¹
• In these developmental toxicity studies performed in rats, all effects were related to the pharmacological activity of abiraterone.¹

Literature Search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File (and/or other resources, including internal/external databases) conducted on 24 June 2024 did not identify any relevant citations pertaining to this topic in patients with prostate cancer.