Prescribing information

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 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 no later than 8 weeks after their most recent platinum-containing regimen. Treatment should be continued until disease progression or unacceptable toxicity. In the case of a missed dose, instruct patients to take their next dose at its regularly scheduled time.

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 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 confirmed.

Bone Marrow Suppression

Hematologic adverse reactions (thrombocytopenia, anemia and neutropenia) have been reported. Grade ≥3 thrombocytopenia, anemia and neutropenia were reported, respectively, in 29%, 25% and 20% of patients receiving Niraparib; discontinuation 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 first 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.

Cardiovascular Effects

Hypertension and hypertensive crisis have been reported. 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 first year and periodically thereafter. Closely monitor patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias and hypertension. Medically manage hypertension with antihypertensive medications and adjustment of the Niraparib dose.

Storage condition: Store below 30°C in a dry place, away from light and moisture. Keep out of the reach of children.

Presentation & packaging: Niraparix Capsule — each commercial box contains 90 capsules in an HDPE pot.