18 12 0 0
Dry mouth 10 4 0.3 0
General disorders and Administration Site Conditions
Fatigue/Asthenia 57 41 8 0.6
Metabolism and Nutrition Disorders
Decreased appetite 25 15 0.3 0.6
Infections and Infestations
Urinary tract infection 13 8 0.8 1
Investigations
AST/ ALT elevation 10 5 4 2
Musculoskeletal and Connective Tissue Disorders
Myalgia 19 20 0.8 0.6
Back pain 18 12 0.8 0
Arthralgia 13 15 0.3 0.6
Nervous system Disorders
Headache 26 11 0.3 0
Dizziness 18 8 0 0
Dysgeusia 10 4 0 0
Psychiatric Disorders
Insomnia 27 8 0.3 0
Anxiety 11 7 0.3 0.6
Respiratory, Thoracic, and Mediastinal Disorders
Nasopharyngitis 23 14 0 0
Dyspnea 20 8 1 1
Cough 16 5 0 0
Skin and Subcutaneous Tissue Disorders
Rash 21 9 0.5 0
Vascular Disorders
Hypertension 20 5 9 2
Table 5 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
(%)
N=number of patients; WBC=white blood cells; ALT=Alanine aminotransferase; AST=Aspartate aminotransferase
Decrease in hemoglobin 85 56 25 0.5
Decrease in platelet count 72 21 35 0.5
Decrease in WBC count 66 37 7 0.7
Decrease in absolute neutrophil count 53 25 21 2
Increase in AST 36 23 1 0
Increase in ALT 28 15 1 2
The following adverse reactions and laboratory abnormalities have been identified in ≥1 to <10% of the 367 patients receiving ZEJULA in the NOVA trial and not included in the table: tachycardia, peripheral edema, hypokalemia, bronchitis, conjunctivitis, gamma-glutamyl transferase increased, blood creatinine increased, blood alkaline phosphatase increased, weight decreased, depression, epistaxis.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on its mechanism of action, ZEJULA can cause fetal harm when administered to pregnant women [see CLINICAL PHARMACOLOGY (12.1)]. There are no data regarding the use of ZEJULA in pregnant women to inform the drug-associated risk. ZEJULA has the potential to cause teratogenicity and/or embryo-fetal death since niraparib is genotoxic and targets actively dividing cells in animals and patients (e.g., bone marrow) [see WARNINGS AND PRECAUTIONS (5.2) and NONCLINICAL TOXICOLOGY (13.1)]. Due to the potential risk to a fetus based on its mechanism of action, animal developmental and reproductive toxicology studies were not conducted with niraparib. Apprise pregnant women of the potential risk to a fetus.
The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in cli |
