FDA label
What is Zejula used for?
Zejula contains niraparib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Zejula lists 2 uses: First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer; Maintenance Treatment of Recurrent Germline BRCA-Mutated Ovarian Cancer.
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Zejula, tablet, film coated
Indications and Usage, quoted from the label by GlaxoSmithKline LLC (NDA214876). Cross-references to other label sections are left out.
First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer
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.
Maintenance Treatment of Recurrent Germline BRCA-Mutated Ovarian Cancer
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.
Source: DailyMed label, set id b7f675e2-159c-490c-b6f4-3f16d9492b7d, version 10, effective July 28, 2026. NDC 0173-0909, one of 3 listings for this product.
Questions
What is Zejula used for?
The FDA label for Zejula lists 2 uses: First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer; Maintenance Treatment of Recurrent Germline BRCA-Mutated Ovarian Cancer.
What drug class is Zejula?
FDA lists niraparib in the Poly(ADP-Ribose) Polymerase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.