Abiraterone / niraparib Pregnancy and Breastfeeding Warnings

Brand names: Akeega

Medically reviewed by Drugs.com. Last updated on Nov 7, 2023.

Abiraterone / niraparib Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Based on the mechanism of action and findings from animal studies, this drug may cause fetal harm and pregnancy loss.

Comments:
-Safety and efficacy have not been established in females.
-Advise males with female partners of reproductive potential to use effective contraception during treatment and for 4 months after last dose of this drug.
-This drug may impair fertility in males of reproductive potential.
-Advise females who are or may become pregnant to handle this drug with protection (e.g., gloves).

NIRAPARIB: Animal studies have not been conducted with niraparib or the combination product. Niraparib is genotoxic and has the potential to cause teratogenicity and/or embryofetal death since it targets actively dividing cells in animals and patients (e.g., bone marrow). Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted. There are no fertility studies conducted in animals; however, repeat-dose toxicity studies observed reduced sperm, spermatids, and germ cells in the epididymides and testes at doses 0.5 and 0.02 times the human exposure.

ABIRATERONE: Animal studies conducted during the period of organogenesis revealed adverse developmental effects (e.g., embryofetal lethality, skeletal and urogenital effects, decreased body weight) and maternal toxicity at systemic exposures approximately 0.03 to 0.3 times the human exposure at the recommended dose. Fertility and repeat-dose toxicity studies in male animals observed reductions in reproductive organ weights, sperm counts, sperm motility, fertility, and altered sperm morphology. These effects occurred at or below systemic exposures similar to humans. Additionally, females mated to males treated with abiraterone acetate experienced a reduced number of corpora lutea, implantations and live embryos, and an increased incidence of pre-implantation loss. Fertility studies in treated female animals observed an increased incidence of irregular or extended estrous cycles and pre-implantation loss. Effects on fertility appeared reversible in male and female animals within 4 to 16 weeks after drug discontinuation. The changes observed in the reproductive organs of animals are consistent with the antiandrogenic pharmacological activity of abiraterone acetate. There are no controlled data using any of the drugs, alone or in combination, in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Abiraterone / niraparib Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown (niraparib, abiraterone)
Excreted into animal milk: Data not available (niraparib, abiraterone)

Comments:
-There is no information available on the presence of niraparib or abiraterone in human milk, or on the effects on the breastfed child or milk production.
-NIRAPARIB: For indications in which this drug is used as a single agent, the manufacturer recommends that lactating women avoid breastfeeding during treatment and for 1 month after last dose. The amount in milk is expected to be low due to high protein binding.
-ABIRATERONE: The safety and efficacy of this drug have not been established in female patients.

See references

Further information

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