PRIMA Safety
The Safety and Tolerability Profile Is Well Characterized1,2
12% of patients discontinued treatment with ZEJULA due to adverse events2,3
12% of patients discontinued treatment with ZEJULA due to adverse events2,3
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)
Side effects of ZEJULA may be managed with dose interruption and modification1,2
Side effects of ZEJULA may be managed with dose interruption and modification1,2
- 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.
Monitoring complete blood counts, blood pressure, and heart rate will help identify the need to dose modify1
†Monitor periodically. Schedule provided as an example.
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
In PRIMA, patients in the overall and individualized populations experienced the same rates of Grades 3-4 leukopenia.1
The individualized starting dose was shown to be effective in exploratory subgroup analyses‡ and is the approved starting dose for ZEJULA in first-line maintenance1
The individualized starting dose was shown to be effective in exploratory subgroup analyses‡ and is the approved starting dose for ZEJULA in first-line maintenance1
HR 0.68 (95% CI, 0.48-0.97) in the overall population (n=258) | HR 0.39 (95% CI, 0.22-0.72) in the HRd population (n=130)
‡These analyses are exploratory in nature and do not control for type 1 error and were not powered to determine treatment effect in any subgroup.
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. 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. 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 [supplementary appendix]. N Engl J Med. 2019;381(25):2391-2402.
