Niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have responded partially or completely 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, preferably at the same time each day. It can be taken with or without food. Treatment should start within 8 weeks of the last platinum-containing regimen and continue until disease progression or unacceptable side effects. If a dose is missed, patients should take it as soon as possible unless it’s almost time for the next scheduled dose.

Warnings and Precautions:
– Myelodysplastic Syndrome/Acute Myeloid Leukemia: Cases of MDS/AML, including fatal outcomes, have been reported. Discontinue Niraparib if MDS/AML is confirmed.
– Bone Marrow Suppression: Hematologic adverse reactions, including thrombocytopenia, anemia, and neutropenia, may occur. Monitor blood counts regularly and discontinue Niraparib if toxicities do not resolve.
– Cardiovascular Effects: Hypertension and hypertensive crisis have been reported. Monitor blood pressure and heart rate regularly and manage hypertension medically.

Pharmaceutical Information:
– Storage: Store below 30°C in a dry place, away from light and moisture, and keep out of reach of children.
– Presentation & Packaging: Each commercial box contains 90 capsules in an HDPE pot.

Niraparib is a once-daily oral medication for maintaining treatment in women with recurrent ovarian, fallopian tube, or primary peritoneal cancer after a positive response to platinum-based chemotherapy.