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
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
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 events3,4
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
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.
References: 1. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2020. 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.