Niraparib
ZEJULA
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.
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
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
NO BOXED WARNINGS
Principal riskThrombocytopenia, dose-limiting
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entry2039 est.
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Niraparib ballicule
