Niraparib

ZEJULA

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Pronunciation: nye-RAP-a-rib (ze-JOO-la)

Niraparib ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Niraparib ballicule

What it isPARP inhibitor exploiting defective DNA repair; maintenance treatment of ovarian cancer.

Why this oneIt has maintenance activity beyond BRCA-mutated disease, broadening eligibility within the PARP class.

What limits itThrombocytopenia is dose-limiting and varies with baseline weight and platelets; hypertension and fatigue also matter.

Niraparib molecular structure (skeletal formula) — Molecular structure: Niraparib

FDA-approved for

ovarian cancer maintenance (2017)

FDA label

Read the full label on DailyMed ↗

FDA dosing	Population	Start	Target	Max
First-line maintenance, HRD-positive advanced ovarian cancer	adult	200 or 300 mg QD (weight/platelet-based)	200–300 mg QD	300 mg QD
Maintenance, recurrent germline BRCA-mutated ovarian cancer	adult	300 mg QD	300 mg QD	300 mg QD

Renal Undefined

Hepatic Moderate impairment (bilirubin 1.5–3× ULN): 200 mg QD; no adjustment for mild; severe not studied

Instructions

Swallow whole; do not chew, crush, or split
May take with or without food; bedtime dosing may reduce nausea
Continue until disease progression or unacceptable toxicity
If a dose is missed or vomited, do not take an extra dose

Available strengths

tab 100, 200, 300 mg

Cautions

Myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
Bone marrow suppression (monitor CBC weekly first month)
Hypertension and cardiovascular effects
Posterior reversible encephalopathy syndrome (PRES)
Embryo-fetal toxicity

Adverse reactions

Nausea
Thrombocytopenia
Anemia
Fatigue
Constipation
Neutropenia
Hypertension

Pregnancy Can cause fetal harm (genotoxic/mechanism of action); advise effective contraception

Lactation Do not breastfeed during treatment and for 1 month after the last dose

Cost

Niraparib (ZEJULA)

Strength		#/mo	CostPlus
100 mg	tab	30 qd	not offered
200 mg	tab	30 qd	not offered
300 mg	tab	30 qd	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Niraparib is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry2039 est.

NO BOXED WARNINGS

Principal riskThrombocytopenia, dose-limiting

Classes and tags

Clinical profile

Therapeutic safety burden3 / 4

Overdose danger2 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk3 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.

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