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Niraparib Pregnancy and Breastfeeding Warnings

Niraparib is also known as: Zejula

Niraparib Pregnancy Warnings

This genotoxic drug has the potential to cause teratogenicity and/or embryo-fetal death due to its targeting of actively dividing cells in animals and patients (e.g., bone marrow). Repeat-dose oral toxicity studies in animals showed reduced sperm, spermatids, and germ cells in epididymides and testes at dose levels that resulted in systemic exposures approximately 0.3 and 0.012 times the human exposure at the recommended dose of 300 mg daily. However, there was a trend toward reversibility of these findings 4 weeks after dosing was stopped. There are no controlled data in human pregnancy, and animal developmental and reproductive toxicity studies have not been conducted. 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.

Based on its mechanism of action, this drug can cause fetal harm. US FDA pregnancy category: Not Assigned Comments: -Apprise female patients of reproductive potential of the possible risk to a fetus; advise them to use effective contraception during treatment and for at least 6 months after the last dose; and perform pregnancy tests on these patients prior to initiating treatment with this drug. -Animal studies have shown that this drug may impair fertility in males of reproductive potential.

See references

Niraparib Breastfeeding Warnings

Breastfeeding is not recommended during treatment and for 1 month after the final dose of this drug. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Zejula (niraparib)." Tesaro Inc., Waltham, MA.

References for breastfeeding information

  1. "Product Information. Zejula (niraparib)." Tesaro Inc., Waltham, MA.

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