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Niraparib Pregnancy and Breastfeeding Warnings

Niraparib is also known as: Zejula

Medically reviewed by Drugs.com. Last updated on July 31, 2020.

Niraparib Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity. There are no controlled data 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.

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug has the potential to cause teratogenicity and/or embryofetal death since it is genotoxic and 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.

Comments:
-This drug can harm a developing fetus.
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Advise females of reproductive potential to use effective contraception during therapy and for at least for 6 months after.
-Based on animal studies, this drug may impair fertility in males of reproductive potential.

See references

Niraparib Breastfeeding Warnings

No information is available on the clinical use of this drug during breastfeeding. Because it is 83% bound to plasma proteins, the amount in milk is likely to be low.

Use is contraindicated.

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.
-Breastfeeding should be discontinued during therapy and for 1 month after.

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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.