FIRST-LINE MAINTENANCE THERAPY OF ADVANCED OVARIAN CANCER WITH ZEJULA (niraparib)

Dosing Information From the PRIMA Trial

Respond with ZEJULA, a convenient
once-daily maintenance treatment1

Once-Daily
Oral Monotherapy

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Taken With
or Without Food

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Taken Any Time
of the Day

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ZEJULA should be taken at approximately the same time each day1

Drug-Drug
Interactions

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No specific drug-drug interactions have been reported with ZEJULA*

*No clinical drug interaction studies have been performed with ZEJULA.


Starting Dose

The only once-daily PARP inhibitor with an individualized starting dose in 1L maintenance1-4

Starting Dose for 1L Maintenance Is Based on Baseline Weight and Platelet Count1

ZEJULA (niraparib) starting dose for first-line maintenance based on baseline weight and/or platelet count
ZEJULA (niraparib) starting dose for first-line maintenance based on baseline weight and/or platelet count

For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily. Monitor patients for hematologic toxicity and reduce the dose further, if needed.1


Dosing and safety Evaluations

Lower rates of select hematologic adverse reactions and similar efficacy were observed with an individualized starting dose1,5,6†

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 Reactions1,5

Bar graph showing grades 3-4 hematologic adverse reactions in PRIMA
Bar graph showing grades 3-4 hematologic adverse reactions in PRIMA

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)6†
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.