Safety | Zejula® (niraparib)

Safety and Tolerability Profile for ZEJULA1

The safety of ZEJULA monotherapy (300 mg once daily) was studied in 367 patients with platinum-sensitive recurrent ovarian, fallopian tube, and primary peritoneal cancer in the NOVA trial.

Adverse reactions (ARs) reported in ≥10% of patients receiving ZEJULA

Grades 1-4a Grades 3-4a
ZEJULA,
n = 367
(%)
Placebo,
n = 179
(%)
ZEJULA,
n = 367
(%)
Placebo,
n = 179
(%)
Blood and lymphatic system disorders
Thrombocytopenia
Thrombocytopenia 61 5 29 0.6
Anemia
Anemia 50 7 25 0
Neutropenia
Neutropenia 30 6 20 2
Leukopenia
Leukopenia 17 8 5 0
Cardiac disorders
Palpitations
Palpitations 10 2 0 0
Gastrointestinal disorders
Nausea
Nausea 74 35 3 1
Constipation
Constipation 40 20 0.8 2
Vomiting 34 16 2 0.6
Abdominal pain/distention
Abdominal pain/distention 33 39 2 2
Mucositis/stomatitis
Mucositis/stomatitis 20 6 0.5 0
Diarrhea
Diarrhea 20 21 0.3 1
Dyspepsia
Dyspepsia 18 12 0 0
Dry mouth
Dry mouth 10 4 0.3 0
General disorders and administration site conditions
Fatigue/asthenia
Fatigue/asthenia 57 41 8 0.6
Metabolism and nutrition disorders
Decreased appetite
Decreased appetite 25 15 0.3 0.6
Infections and infestations
Urinary tract infection
Urinary tract infection 13 8 0.8 1
Investigations
AST/ALT elevation
AST/ALT elevation 10 5 4 2
Musculoskeletal and connective tissue disorders
Myalgia
Myalgia 19 20 0.8 0.6
Back pain
Back pain 18 12 0.8 0
Arthralgia
Arthralgia 13 15 0.3 0.6
Nervous system disorders
Headache
Headache 26 11 0.3 0
Dizziness
Dizziness 18 8 0 0
Dysgeusia
Dysgeusia 10 4 0 0
Psychiatric disorders
Insomnia
Insomnia 27 8 0.3 0
Anxiety
Anxiety 11 7 0.3 0.6
Respiratory, thoracic, and mediastinal disorders
Nasopharyngitis
Nasopharyngitis 23 14 0 0
Dyspnea
Dyspnea 20 8 1 1
Cough
Cough 16 5 0 0
Skin and subcutaneous tissue disorders
Rash
Rash 21 9 0.5 0
Vascular disorders
Hypertension
Hypertension 20 5 9 2

a Based on Common Terminology Criteria for Adverse Events, version 4.02.


Abnormal laboratory findings in ≥25% of patients receiving ZEJULA

Grades 1-4 Grades 3-4
ZEJULA,
n = 367
(%)
Placebo,
n = 179
(%)
ZEJULA,
n = 367
(%)
Placebo,
n = 179
(%)
Decrease in hemoglobin
Decrease in hemoglobin 85 56 25 0.5
Decrease in platelet count
Decrease in platelet count 72 21 35 0.5
Decrease in WBC count
Decrease in WBC count 66 37 7 0.7
Decrease in absolute neutrophil count
Decrease in absolute neutrophil count 53 25 21 2
Increase in AST
Increase in AST 36 23 1 0
Increase in ALT
Increase in ALT 28 15 1 2

ALT, alanine aminotransferase; AST, aspartate aminotransferase; WBC, white blood cell.

  • The permanent discontinuation rate due to ARs was 15%

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.

Please see Important Safety Information below and full Prescribing Information.

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