FIRST-LINE MAINTENANCE THERAPY OF ADVANCED OVARIAN CANCER WITH ZEJULA (niraparib)
Safety Data From the PRIMA Trial
An established safety and tolerability profile, consistent with previous clinical trial experience1,2
12% of patients discontinued treatment with ZEJULA due to adverse events2,3
Adverse events resulting in discontinuation of ZEJULA in >1% of patients included thrombocytopenia (3.7%), anemia (1.9%), and nausea and neutropenia (1.2% each)1
Adverse Reactions Reported in ≥10% of All Patients Receiving ZEJULA in PRIMA1*
Side effects of ZEJULA may be managed with dose interruption and modification1,2
- In PRIMA, adverse events led to dose reduction or interruption in 80% of patients, most frequently from thrombocytopenia (56%), anemia (33%), and neutropenia (20%)1
All adverse reactions consist of grouped preferred terms except for nausea, vomiting, decreased appetite, headache, and insomnia, which are single preferred terms.
CTCAE = Common Terminology Criteria for Adverse Events version 4.02.
Includes neutropenia, neutropenic infection, neutropenic sepsis, febrile neutropenia.
Includes leukopenia, lymphocyte count decreased, lymphopenia, white blood cell count decreased.
Includes blood creatinine increased, blood urea increased, acute kidney injury, renal failure, blood creatine increased.
Monitoring complete blood counts, blood pressure, and heart rate helps identify the need to dose modify1
Rest of year
After year 1¶
Blood pressure and heart rate
1st and 2nd month
Rest of year
After year 1¶
¶Monitor periodically. Schedule provided as an example.
Lower rates of select hematologic adverse reactions and similar efficacy were observed with an individualized starting dose1,4,5#
PRIMA prospectively evaluated the safety and efficacy of an individualized starting dose of either 200 mg or 300 mg,
selected based on baseline weight and platelet count, as well as a fixed starting dose of 300 mg1#
Rates of Select Grade 3-4 Hematologic Adverse Reactions1,2
In PRIMA, patients in the overall and individualized populations experienced the same rates of grades 3-4 leukopenia.1
The individualized starting dose was shown to be effective in
exploratory subgroup analyses# and is the approved starting dose
for ZEJULA in first-line maintenance1
HR 0.68 (95% CI, 0.48-0.97) in the overall population (n=258)
HR 0.39 (95% CI, 0.22-0.72) in the HRd population (n=130)
In the BRCAm population (n=53)5#
HR, 0.29 (95% CI, 0.128-0.667)
#These analyses are exploratory in nature, do not control for type 1 error, and are not powered to determine treatment effect in any subgroup.