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
Chart showing possible adverse reactions

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; ENGOT-OV16/NOVA Investigators. The exposure-response relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD. 4. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. 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; ENGOT-OV16/NOVA Investigators. The exposure-response relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD. 4. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164.

Patient characteristics

PATIENT CHARACTERISTICS

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AR monitoring

AR MONITORING

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Dosing

DOSING

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Dosing guide

DOSING GUIDE

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