PARP inhibitors
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Zejula Dosage

Drug Detail:Zejula (Niraparib [ nye-rap-a-rib ])

Generic Name: NIRAPARIB TOSYLATE MONOHYDRATE 100mg

Dosage Form: capsule

Drug Class: PARP inhibitors

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

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)].

Select patients for therapy based on an FDA-approved companion diagnostic for ZEJULA [see Dosage and Administration (2.1)].

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.

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 tablet 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

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For patients weighing <77 kg (<170 lbs) OR with a platelet count of <150,000/mcL, the recommended dosage is 200 mg taken orally once daily.
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For patients weighing ≥77 kg (≥170 lbs) AND who have a platelet count ≥150,000/mcL, the recommended dosage is 300 mg 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 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.

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.

Table 1. Recommended Dose Modifications for Adverse Reactions
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

200 mg/day

Second dose reduction

Discontinue ZEJULA.

100 mg/daya
Table 2. Dose Modifications for Non-Hematologic Adverse Reactions
CTCAE = Common Terminology Criteria for Adverse Events.

Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management
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Withhold ZEJULA for a maximum of 28 days or until resolution of adverse reaction.
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Resume ZEJULA at a reduced dose per Table 1.

CTCAE ≥Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day

Discontinue ZEJULA.
Table 3. Dose Modifications for Hematologic Adverse Reactions
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:

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Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
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Resume ZEJULA at same or reduced dose per Table 1.
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If platelet count is <75,000/mcL, resume at a reduced dose.

Second occurrence:

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Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
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Resume ZEJULA at a reduced dose per Table 1.
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Discontinue ZEJULA if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily.a

Neutrophil <1,000/mcL or hemoglobin <8 g/dL
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Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1,500/mcL or hemoglobin returns to ≥9 g/dL.
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Resume ZEJULA at a reduced dose per Table 1.
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Discontinue ZEJULA if neutrophils and/or hemoglobin have not returned to acceptable levels within 28 days of the dose interruption period or if the patient has already undergone dose reduction to 100 mg once daily.a

Hematologic adverse reaction requiring transfusion
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For patients with platelet count ≤10,000/mcL, platelet transfusion should be considered. If there are other risk factors such as coadministration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count.
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Resume ZEJULA at a reduced dose.

Dosage Adjustment for Hepatic Impairment

Moderate Hepatic Impairment

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 [see Dosage and Administration (2.3), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].

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