ZEJULA- niraparib capsule
ZEJULA® is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
ZEJULA® is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
- a deleterious or suspected deleterious BRCA mutation, or
- genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy [see Clinical Studies (14.2)].
Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA.
Select patients for treatment of advanced ovarian cancer after three or more chemotherapy regimens associated with HRD positive status based on either deleterious or suspected deleterious BRCA mutation and/or genomic instability score (GIS) [see Clinical Studies (14.2) ].
Information on FDA-approved tests for the detection of either deleterious or suspected deleterious BRCA mutation or genomic instability for this indication is available at: http://www.fda.gov/CompanionDiagnostics.
The recommended dose of ZEJULA is 300 mg (three 100 mg capsules) taken orally once daily.
For the maintenance treatment of recurrent ovarian cancer, patients should start treatment with ZEJULA no later than 8 weeks after their most recent platinum-containing regimen.
ZEJULA treatment should be continued until disease progression or unacceptable toxicity.
Instruct patients to take their dose of ZEJULA at approximately the same time each day. Each capsule should be swallowed whole. ZEJULA may be taken with or without food. Bedtime administration may be a potential method for managing nausea.
In the case of a missed dose of ZEJULA, instruct patients to take their next dose at its regularly scheduled time. If a patient vomits or misses a dose of ZEJULA, an additional dose should not be taken.
To manage adverse reactions, consider interruption of treatment, dose reduction, or dose discontinuation. The recommended dose modifications for adverse reactions are listed in Tables 1, 2 and 3.
|Starting dose||300 mg/day (three 100 mg capsules)|
|First dose reduction||200 mg/day (two 100 mg capsules)|
|Second dose reduction||100 mg/day * (one 100 mg capsule)|
|Non-hematologic CTCAE * ≥ Grade 3 adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment|| |
|CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day||Discontinue medication.|
|Monitor complete blood counts weekly for the first month, monthly for the next 11 months of treatment and periodically after this time [see Warnings and Precautions (5.1)].|
|Platelet count <100,000/µL||First occurrence: |
|Second occurrence: |
|Neutrophil <1,000/µL or Hemoglobin <8 g/dL|| |
|Hematologic adverse reaction requiring transfusion|| |
100 mg capsule having a white body with “100 mg” printed in black ink, and a purple cap with “Niraparib” printed in white ink.
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