PRIMA Trial Dosing

For First-Line Maintenance Treatment of Advanced Ovarian Cancer1

Starting Dose for 1L Maintenance Is Based on Baseline Weight and Platelet Count1

ZEJULA Recommended Dose Modifications for Adverse Reactions1

Starting Dose

ZEJULA (niraparib) starting dose for first-line maintenance based on baseline weight and/or platelet count
ZEJULA (niraparib) starting dose for first-line maintenance based on baseline weight and/or platelet count

For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.

Lower Rates of Select Hematologic Adverse Reactions Were Observed With an Individualized Starting Dose1

PRIMA prospectively evaluated the safety and efficacy of an individualized starting dose of either 200 mg or 300 mg, selected based on baseline weight and platelet count, as well as a fixed starting dose of 300 mg.1

Rates of Select Grades 3-4 Hematologic Adverse Reactions1,2

Bar graph showing grades 3-4 hematologic adverse reactions

In PRIMA, patients in the overall and individualized populations experienced the same rates of Grades 3-4 leukopenia.

The Safety and Tolerability Profile Is Well Characterized and Consistent With Previous Clinical Trial Experience1,3

12% of patients discontinued treatment with ZEJULA due to adverse events.3,4

Adverse events resulting in discontinuation of ZEJULA in >1% of patients included thrombocytopenia (3.7%), anemia (1.9%), and nausea and neutropenia (1.2% each).

Adverse Reactions Reported in ≥10% of All Patients Receiving ZEJULA in PRIMA1

Adverse reactions reported in >= 10% of all patients in PRIMA

Side effects of ZEJULA may be managed with dose interruption and modification1,3

  • Adverse events led to dose interruptions or reduction in 80% of patients, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%)
  • No specific drug-drug interactions have been reported with ZEJULA*

*No clinical drug interaction studies have been performed with ZEJULA.

1L, first-line; ALT, alanine transaminase; AST, aspartate transaminase; CI, confidence interval; HR, hazard ratio; HRd, homologous recombination deficient.

shadow-divider

Efficacy Data

View efficacy data for
all indications

References: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2021. 2. Mirza MR, González-Martín A, Graybill W, et al. Evaluation of an individualized starting dose of niraparib in the PRIMA/ENGOT-OV26/GOG-3012 study. Poster presented at: American Society of Clinical Oncology Congress; May 29-31, 2020; virtual. 3. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):‍2391-2402. 4. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. Niraparib in patients with newly diagnosed advanced ovarian cancer [supplementary appendix]. N Engl J Med. 2019;381(25):‍2‍391-2402.