Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed.
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dose of ZEJULA as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily.
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.
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.
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.
2.2 Dose 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 cou |
