ZEJULA
ZEJULA- niraparib capsule
GlaxoSmithKline LLC
1 INDICATIONS AND USAGE
1.1 First-Line Maintenance Treatment of Advanced Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
1.2 Maintenance Treatment of Recurrent Germline BRCA -mutated Ovarian Cancer
ZEJULA is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (gBRCA mut) recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA [see Dosage and Administration (2.1)].
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
Maintenance Treatment of Recurrent Germline BRCA -mutated Ovarian Cancer
Select patients for the maintenance treatment of recurrent ovarian cancer with ZEJULA based on the presence of deleterious or suspected deleterious germline BRCA mutations [see Clinical Studies (14.2)].
Information on FDA-approved tests for the detection of deleterious or suspected deleterious germline BRCA mutations for this indication is available at https://www.fda.gov/companiondiagnostics.
2.2 Recommended Dosage
Continue treatment with ZEJULA until disease progression or unacceptable toxicity.
Instruct patients to take their dose of ZEJULA at approximately the same time each day. Advise patients to swallow each capsule whole and not to chew, crush, or split ZEJULA prior to swallowing. 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.
First-Line Maintenance Treatment of Advanced Ovarian Cancer
• For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg (two 100-mg capsules) taken orally once daily.
• For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg (three 100-mg capsules) taken orally once daily.
For the maintenance treatment of advanced ovarian cancer, patients should start treatment with ZEJULA no later than 12 weeks after their most recent platinum-containing regimen.
Maintenance Treatment of Recurrent Germline BRCA- mutated Ovarian Cancer
The recommended dosage 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.
2.3 Dosage Adjustments for Adverse Reactions
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.
a If further dose reduction below 100 mg/day is required, discontinue ZEJULA. | ||
Starting Dose Level | 200 mg | 300 mg |
First dose reduction | 100 mg/daya (one 100-mg capsule) | 200 mg/day (two 100-mg capsules) |
Second dose reduction | Discontinue ZEJULA. | 100 mg/daya (one 100-mg capsule) |
CTCAE = Common Terminology Criteria for Adverse Events. | ||||
Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management |
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CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day | Discontinue ZEJULA. |
a If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue ZEJULA [see Warnings and Precautions (5.1, 5.2)]. | ||||||
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/mcL | First occurrence:
Second occurrence:
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Neutrophil <1,000/mcL or hemoglobin <8 g/dL |
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Hematologic adverse reaction requiring transfusion |
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