A once-daily PARP inhibitor for recurrent ovarian cancer

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.

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 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.

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 first year and periodically thereafter during treatment with Niraparib. 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.