Niraparib 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.
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 progression or unacceptable toxicity. In the case of a missed dose of Niraparib, instruct patients to take their next dose at its regularly scheduled.
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including cases with fatal outcome,have been reported in patients who received Niraparib. In Trial 1 (NOVA), MDS/AML occurred in 5 out of 367 (1.4%) of patients who received Niraparib and in 2 out of 179 (1.1%) patients who received placebo. Overall, MDS/AML has been reported in 7 out of 751 (0.9%) patients treated with Niraparib in clinical studies.
The duration of Niraparib treatment in patients prior to developing MDS/AML varied from 1 month to 2 years. All patients had received previous chemotherapy with platinum and some had also received other DNA damaging agents and radiotherapy. Discontinue Niraparib if MDS/AML is con_rmed.
Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported in patients treated with Niraparib. Grade _3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 29%, 25%, and 20% of patients receiving Niraparib. Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 1%, and 2% of patients. Do not start Niraparib until patients have recovered from hematological toxicity caused by previous chemotherapy (_ Grade 1).
Monitor complete blood counts weekly for the _rst month, monthly for the next 11 months of treatment, and periodically after this time. If hematological toxicities do not resolve within 28 days following interruption, discontinue Niraparib, and refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample for cytogenetics.
Hypertension and hypertensive crisis have been reported in patients treated with Niraparib. Grade 3-4 hypertension occurred in 9% of Niraparib treated patients compared to 2% of placebo treated patients in Trial 1. Discontinuation due to hypertension occurred in 1% of patients.
Monitor blood pressure and heart rate monthly for the _rst year and periodically thereafter during treatment with Niraparib. Closely monitor patients with cardiovascular disorders, especially coronary insu_ciency, cardiac arrhythmias, and hypertension. Medically manage hypertension with antihypertensive medications and adjustment of the Niraparib dose.