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QUADRA Safety

Safety Signals Observed in QUADRA Were Consistent With Those Found in NOVA1,2

However, rates of most common adverse reactions observed in QUADRA were different from NOVA, and fatal adverse reactions occurred in 2% of patients, including cardiac arrest. In QUADRA, serious adverse reactions occurred in 43% of patients receiving ZEJULA. Serious adverse reactions in >3% of patients were small intestinal obstruction (7%), vomiting (6%), nausea (5%), and abdominal pain (4%).


Adverse reactions in QUADRA led to3:

Dose reduction or interruption, 73%

Most frequently from:

  • Thrombocytopenia, 40%
  • Anemia, 21%
  • Fatigue, 9%
  • Nausea, 13%
  • Vomiting, 11%
  • Neutropenia, 11%
  • Abdominal pain, 5%
Discontinuation, 21%


*Monitor periodically. Schedule provided as an example.

Common lab abnormalities (Grades 1–4) in ≥25% of patients who received ZEJULA in QUADRA included3:
Decreased hemoglobin (83%), increased glucose (66%), decreased platelets (60%), decreased lymphocytes (57%), decreased leukocytes (53%), decreased magnesium (46%), increased alkaline phosphatase (40%), increased gamma glutamyl transferase (40%), increased creatinine (36%), decreased sodium (34%), decreased neutrophils (34%), increased aspartate aminotransferase (29%), and decreased albumin (27%).

EFFICACY DATA

View efficacy data for all indications

See the Data
ZEJULA (niraparib) Dosing Information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing

References: 1.Matulonis UA, Monk BJ, Secord AA, et al. Baseline platelet count and body weight as predictors of early dose modification in the QUADRA trial of niraparib monotherapy for the treatment of heavily pretreated (≥4th line), advanced, recurrent high-grade serous ovarian cancer. Presented at: SGO 50th Annual Meeting on Women's Cancer; March 16-19, 2019; Honolulu, HI. 2. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792. 3. ZEJULA (niraparib). Prescribing Information. GlaxoSmithKline; 2020.