Cancer Treatment Side Effects & Warnings

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What is the dosage for Zejula?

Patient Selection For Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies

Select patients for treatment of advanced ovarian cancer after 3 or more
chemotherapy regimens associated with HRD positive status based on either
deleterious or suspected deleterious BRCA mutation and/or genomic instability
score (GIS).

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 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 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 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.

Treatment Of Advanced Ovarian Cancer After 3 Or More Chemotherapies

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

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
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)
a If further dose reduction below 100 mg/day is required, discontinue
Zejula.

Table 2: Dose Modifications for Non-Hematologic Adverse Reactions

Non-hematologic CTCAE ≥Grade 3 adverse reaction that persists despite medical management
  • 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 Zejula.
CTCAE = Common Terminology Criteria for Adverse Events.

Table 3: Dose Modifications for Hematologic Adverse Reactions

Monitor complete blood counts weekly for the first
month, monthly for the next 11 months of treatment, and periodically
after this time.
Platelet count <100,000/mcL First occurrence:

  • Withhold Zejula for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mcL.
  • Resume Zejula at same or reduced dose per Table 1.
  •   If platelet count is <75,000/mcL, 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/mcL.
  • 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/mcL 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/mcL 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/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.
  • Resume Zejula at a reduced dose.
a If myelodysplastic
syndrome or acute myeloid leukemia (MDS/AML) is confirmed,
discontinue Zejula.

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.



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