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Niranib (Niraparib 100 mg)
Therapeutic Class: polymerase (PARP) inhibitors
Pack Size: Each HDPE container contains 30 Capsules, each of which contains Niraparib INN 100 mg.

INDICATIONS AND USAGE
NIRANIB 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.
DOSAGE AND ADMINISTRATION
The recommended dose of Niraparib as monotherapy is 300 mg (three 100 mg capsules) taken orally once daily.
Instruct patients to take their dose of Niraparib at approximately the same time each day. Each capsule should be swallowed whole. Niraparib may be taken with or without food. Bedtime administration may be a potential method for managing nausea. Patients should start treatment with Niraparib no later than 8 weeks after their most recent platinum-containing regimen. Niraparib treatment should be continued until disease progres- sion or unacceptable toxicity.
In the case of a missed dose of Niraparib, instruct patients to take their next dose at its regularly scheduled time.
If a patient vomits or misses a dose of Niraparib, 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.