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These highlights do not include all the information needed to use ZEJULA safely and effectively. See full prescribing information for ZEJULA. ZEJULA (niraparib) tablets, for oral useInitial U.S. Approval: 2017
Medication labelWhy this: Advisory · dailymed-prescription
ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration ( 2.1 )] . ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAmut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA [see Dosage and Administration (2.1)].
- generic_name
- niraparib
- product_names
- niraparib
- ndc
- 0173-0909, 0173-0909-13, 0173-0912, 0173-0912-13, 0173-0912-61, 0173-0915, 0173-0915-13, 0173-0915-61
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en