Adverse Reactions (ARs)
The Side Effect Profile of ZEJULA Is Well-Characterized1
Side effects were manageable with dose interruption and/or dose reduction1
- Adverse reactions led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%)1
- For patients starting at a 300-mg dose, expect to dose interrupt and modify in approximately 50% of patients in the first month2
- Treatment efficacy was maintained with dose modifications3
- No on-treatment deaths were reported during the study4
ARs reported in ≥10% of patients receiving ZEJULA1
Adverse reactions (ARs) reported in ≥10% of patients receiving ZEJULA1
a CTCAE, Common Terminology Criteria for Adverse Events, version 4.02.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Because clinical trials are conducted under widely varying conditions, AR rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Data on file. TESARO, Inc. 3. Wang J, Zhang Z-Y, Mirza MR, et al. The exposure-response relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Presented at: European Society for Medical Oncology Congress; September 8-12, 2017; Madrid, Spain. 4. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164.
Thrombocytopenia
Any Grade: ZEJULA 61% vs. Placebo 5%
Grade ≥3: ZEJULA 29% vs. Placebo 0.6%
Anemia
Any Grade: ZEJULA 50% vs. Placebo 7%
Grade ≥3: ZEJULA 25% vs. Placebo 0%
Neutropenia
Any Grade: ZEJULA 30% vs. Placebo 6%
Grade ≥3: ZEJULA 20% vs. Placebo 2%
Leukopenia
Any Grade: ZEJULA 17% vs. Placebo 8%
Grade ≥3: ZEJULA 5% vs. Placebo 0%
Palpitations
Any Grade: ZEJULA 10% vs. Placebo 2%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Nausea
Any Grade: ZEJULA 74% vs. Placebo 35%
Grade ≥3: ZEJULA 3% vs. Placebo 1%
Constipation
Any Grade: ZEJULA 40% vs. Placebo 20%
Grade ≥3: ZEJULA 0.8% vs. Placebo 2%
Vomiting
Any Grade: ZEJULA 34% vs. Placebo 16%
Grade ≥3: ZEJULA 2% vs. Placebo 0.6%
Abdominal pain/distention
Any Grade: ZEJULA 33% vs. Placebo 39%
Grade ≥3: ZEJULA 2% vs. Placebo 2%
Mucositis/stomatitis
Any Grade: ZEJULA 20% vs. Placebo 6%
Grade ≥3: ZEJULA 0.5% vs. Placebo 0%
Diarrhea
Any Grade: ZEJULA 20% vs. Placebo 21%
Grade ≥3: ZEJULA 0.3% vs. Placebo 1%
Dyspepsia
Any Grade: ZEJULA 18% vs. Placebo 12%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Dry mouth
Any Grade: ZEJULA 10% vs. Placebo 4%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0%
Fatigue/Asthenia
Any Grade: ZEJULA 57% vs. Placebo 41%
Grade ≥3: ZEJULA 8% vs. Placebo 0.6%
Decreased appetite
Any Grade: ZEJULA 25% vs. Placebo 15%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0.6%
Urinary tract infection
Any Grade: ZEJULA 13% vs. Placebo 8%
Grade ≥3: ZEJULA 0.8% vs. Placebo 1%
AST/ ALT elevation
Any Grade: ZEJULA 10% vs. Placebo 5%
Grade ≥3: ZEJULA 4% vs. Placebo 2%
Myalgia
Any Grade: ZEJULA 19% vs. Placebo 20%
Grade ≥3: ZEJULA 0.8% vs. Placebo 0.6%
Back pain
Any Grade: ZEJULA 18% vs. Placebo 12%
Grade ≥3: ZEJULA 0.8% vs. Placebo 0%
Arthralgia
Any Grade: ZEJULA 13% vs. Placebo 15%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0.6%
Headache
Any Grade: ZEJULA 26% vs. Placebo 11%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0%
Dizziness
Any Grade: ZEJULA 18% vs. Placebo 8%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Dysgeusia
Any Grade: ZEJULA 10% vs. Placebo 4%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Insomnia
Any Grade: ZEJULA 27% vs. Placebo 8%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0%
Anxiety
Any Grade: ZEJULA 11% vs. Placebo 7%
Grade ≥3: ZEJULA 0.3% vs. Placebo 0.6%
Nasopharyngitis
Any Grade: ZEJULA 23% vs. Placebo 14%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Dyspnea
Any Grade: ZEJULA 20% vs. Placebo 8%
Grade ≥3: ZEJULA 1% vs. Placebo 1%
Cough
Any Grade: ZEJULA 16% vs. Placebo 5%
Grade ≥3: ZEJULA 0% vs. Placebo 0%
Rash
Any Grade: ZEJULA 21% vs. Placebo 9%
Grade ≥3: ZEJULA 0.5% vs. Placebo 0%
Hypertension
Any Grade: ZEJULA 20% vs. Placebo 5%
Grade ≥3: ZEJULA 9% vs. Placebo 2%
Because clinical trials are conducted under widely varying conditions, AR rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.1
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Data on file. TESARO, Inc. 3. Wang J, Zhang Z-Y, Mirza MR, et al. The exposure-response relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Presented at: European Society for Medical Oncology Congress; September 8-12, 2017; Madrid, Spain. 4. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164.
PATIENT CHARACTERISTICS
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