The Side Effect Profile of ZEJULA is Well-Characterized1
Adverse reactions have been reported in patients taking ZEJULA. Please see Important Safety Information, including Warnings and Precautions, below.
Side effects were managed 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
No on-treatment deaths were reported during the study3
Adverse reactions (ARs) reported in ≥10% of patients receiving ZEJULA1
CTCAE, Common Terminology Criteria for Adverse Events, version 4.02. ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase.
Abnormal laboratory findings (grades 1-4) in ≥25% of patients receiving ZEJULA1
- Decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%), and increase in ALT (28%)
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Rate of grade ≥3 ARs after cycle 3 in patients receiving ZEJULA3
- No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia3
- All bleeding events associated with thrombocytopenia were grade 1 or 2; 1 patient had grade 3 petechiae and hematoma concurrent with a serious adverse event of pancytopenia
a Thrombocytopenia and decreased platelet count.
b Anemia and decreased hemoglobin count.
c Neutropenia, decreased neutrophil count, and febrile neutropenia.
d Fatigue, asthenia, malaise, and lethargy.
AR, adverse reaction.
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
In the clinical trial, 15% of the overall population discontinued treatment due to ARs1
Discontinuation due to hematologic ARs was uncommon 1,3
- Hematologic ARs generally occurred within the first 3 treatment cycles; after dose adjustment on the basis of an individual adverse-event profile, the incidence of grade 3/4 thrombocytopenia, neutropenia, or fatigue was infrequent beyond cycle 33
- Only 1 patient (<1%) in the ZEJULA arm experienced febrile neutropenia2
Monitoring for hematologic ARs1
Monitor complete blood counts weekly for the first month, monthly for the next 11 months, and as needed after 12 months.
Schedule provided as an example.
AR, adverse reaction.
Thrombocytopenia Was Observed in the NOVA Trial1,3
Thrombocytopenia was typically transient with dose modification3
Platelet levels decreased initially but showed stabilization after cycle 3 with appropriate dose modification3
- Among patients treated with ZEJULA, the median time to onset of grade 3/4 thrombocytopenia was 23 days2
- Most grade 3/4 thrombocytopenia events weJe tran1 sient with dose inteJruption or dose
reduction, and the median duration was 10 days2
Change in platelet levels from baseline over time3
SE, standard error.
Incidence of grade 3/4 thrombocytopenia in the ZEJULA arm of the NOVA trial:
in treatment months 1-52
Please see Important Safety Information below and full Prescribing Information.