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Zejula Dosage

Generic name: niraparib 100mg
Dosage form: capsule

Medically reviewed by Drugs.com. Last updated on Apr 29, 2020.

2.1 Patient Selection for Treatment of Advanced Ovarian Cancer after Three or More Chemotherapies

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 (14.3)].

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.

Recommended Dosage

Continue ZEJULA treatment 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 less than 77 kg (170 lbs) OR with a platelet count of less than 150,000/μL, the recommended dose is 200 mg (two 100-mg capsules) taken orally once daily.
For patients weighing greater than or equal to 77 kg (170 lbs) AND who have a platelet count greater than or equal to 150,000/μL, the recommended dose 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 Ovarian Cancer

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.

Treatment of Advanced Ovarian Cancer after Three or More Chemotherapies

The recommended dose of ZEJULA is 300 mg (three 100-mg capsules) taken orally once daily.

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.

Table 1: Recommended Dose Modifications for Adverse Reactions
Starting dose level 200 mg 300 mg
a If further dose reduction below 100 mg/day is required, discontinue ZEJULA.

First dose reduction

100 mg/daya (one 100-mg capsule)

200 mg/day (two 100-mg capsules)

Second dose reduction

Discontinue medication.

100 mg/daya (one 100-mg capsule)

Table 2: Dose Modifications for Non-Hematologic Adverse Reactions
a CTCAE=Common Terminology Criteria for Adverse Events

Non-hematologic CTCAEa ≥ Grade 3 adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment

Withhold ZEJULA for a maximum of 28 days or until resolution of adverse reaction.
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 medication.

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/µL

First occurrence:

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

Second occurrence:

Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/µL.
Resume ZEJULA at a reduced dose per Table 1.
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/µL or Hemoglobin <8 g/dL

Withhold ZEJULA for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1,500/µL or hemoglobin returns to ≥9 g/dL.
Resume ZEJULA at a reduced dose per Table 1.
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

For patients with platelet count ≤10,000/µL, platelet transfusion should be considered. If there are other risk factors such as co-administration of anticoagulation or antiplatelet drugs, consider interrupting these drugs and/or transfusion at a higher platelet count.
Resume ZEJULA at a reduced dose.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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