Niraparib

What it is and how it works

Mechanism of Action Niraparib is an inhibitor of PARP enzymes, including PARP-1 and PARP-2, that play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, apoptosis, and cell death. Increased niraparib‑induced cytotoxicity was observed in tumor cell lines with or without deficiencies in BRCA1/2 .

Indications

is a poly (ADP-ribose) polymerase (PARP) inhibitor 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: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. ( 1.1 , 2.1 ) • for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated 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.

Dosage and administration (summary)

• First ‑ Line Maintenance Treatment of HRD ‑ Positive Advanced Ovarian Cancer: o For patients weighing <77 kg (<170 lbs) OR with a platelet count <150,000/mcL, the recommended dosage is 200 mg taken orally once daily. o For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/mcL, the recommended dosage is 300 mg taken orally once daily. • Maintenance Treatment of Recurrent Germline BRCA ‑ Mutated Ovarian Cancer: The recommended dosage is 300 mg taken orally once daily. • Continue treatment until disease progression or unacceptable toxicity. • ZEJULA may be taken with or without food.

Contraindications

None. None.

Warnings and precautions

• Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): MDS/AML occurred in patients exposed to ZEJULA, and some cases were fatal. Monitor patients for hematological toxicity and discontinue if MDS/AML is confirmed. • Bone Marrow Suppression: Test complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter for clinically significant changes.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action, ZEJULA can cause fetal harm when administered to pregnant women . There are no data regarding the use of ZEJULA in pregnant women to inform the drug-associated risk.

Storage and supply

is available as oval-shaped, film-coated tablets containing 100 mg, 200 mg, or 300 mg of niraparib free base. ZEJULA 100-mg tablets are gray, debossed with “100” on one side and “Zejula” on the other side. Bottle of 30 tablets (NDC 0173-0909-13). ZEJULA 200-mg tablets are blue, debossed with “200” on one side and “Zejula” on the other side.

Source: Niraparib (Zejula) — US FDA prescribing information, 2026-07-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.