ZEJULA

ZEJULA- niraparib capsule
TESARO, Inc.

1 INDICATIONS AND USAGE

1.1 Maintenance Treatment of Recurrent Ovarian Cancer

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.

1.2 Treatment of Advanced Ovarian Cancer after Three or More Chemotherapies

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.

2 DOSAGE AND ADMINISTRATION

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 (14.2) ].

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.

2.2 Recommended Dosage

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.

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
Dose level Dose
*
If further dose reduction below 100 mg/day is required, discontinue ZEJULA.
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)
Table 2: Dose modifications for non-hematologic adverse reactions
*
CTCAE=Common Terminology Criteria for Adverse Events
Non-hematologic CTCAE * ≥ 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. Up to 2 dose reductions are permitted.
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
*
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.*
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.*
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.

3 DOSAGE FORMS AND STRENGTHS

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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