Niraparib

The Basics

What is Niraparib?

Used for the maintenance treatment of women with recurrent ovarian, fallopian tube, or primary peritoneal cancer that comes back.

Brand names for Niraparib

Zejula

How Niraparib is classified

Antineoplastic Agents, Enzyme Inhibitors, Signal Transduction Inhibitors, PARP Inhibitors

Niraparib During Pregnancy

Niraparib pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Niraparib while pregnant

Based on its mechanism of action, ZEJULA can cause fetal harm when administered to pregnant women [see CLINICAL PHARMACOLOGY]. There are no data regarding the use of ZEJULA in pregnant women to inform the drug-associated risk. ZEJULA has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see WARNINGS AND PRECAUTIONS and Nonclinical Toxicology]. Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. Apprise pregnant women of the potential risk to a fetus. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Taking Niraparib While Breastfeeding

What are recommendations for lactation if you're taking Niraparib?

No information is available on the clinical use of niraparib during breastfeeding. Because niraparib is 83% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during niraparib therapy and for 1 month following therapy.

Maternal / infant drug levels

No information is available on the clinical use of niraparib during breastfeeding. Because niraparib is 83% bound to plasma proteins, the amount in milk is likely to be low. The manufacturer recommends that breastfeeding be discontinued during niraparib therapy and for 1 month following therapy.

Possible effects of Niraparib on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Niraparib

None listed