Generic name: niraparib 100mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
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.
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.
|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)|
|Non-hematologic CTCAE* ≥ Grade 3 adverse reaction where prophylaxis is not considered feasible or adverse reaction persists despite treatment||
|CTCAE ≥ Grade 3 treatment-related adverse reaction lasting more than 28 days while patient is administered ZEJULA 100 mg/day||Discontinue medication.|
|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:
|Neutrophil <1,000/µL or Hemoglobin <8 g/dL||
|Hematologic adverse reaction requiring transfusion||
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- Drug class: PARP inhibitors