• Monitor for signs and symptoms of MDS or AML (weakness, feeling tired, fever, weight loss, frequent infections, bruising, bleeding easily, breathlessness, blood in urine or stool, low blood cell counts, need for blood transfusions) periodically during therapy.
• Monitor BP and HR weekly for first 2 mo, then monthly for first year, and periodically during therapy. Closely monitor patients with cardiovascular disorders, especially coronary artery disease, cardiac arrhythmias, and hypertension. Manage hypertension with antihypertensive medications and adjustment of niraparib dose, if necessary.
• Monitor for signs and symptoms of PRES (seizure, headache, altered mental status, visual disturbance, cortical blindness, with or without associated hypertension). If symptoms occur, promptly discontinue niraparib.

Lab Test Considerations:

• Patient selection is based on either deleterious or suspected deleterious BRCA mutation and/or genomic instability score. Information on FDA-approved tests for the detection of either deleterious or suspected deleterious BRCA mutation or genomic instability for this indication is available at https://www.fda.gov/companiondiagnostics.Verify negative pregnancy test before starting therapy.
  • Monitor CBC weekly for first mo, monthly for next 11 mo, and periodically during therapy. Do not start niraparib until recovery of hematological toxicity from previous chemotherapy has recovered. If platelet count <100,000 /mm³/L:First occurrence: Hold niraparib for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000 /mm³/L. Resume at same or ↓ dose. If platelet count <75,000/ mm³/L, resume at a ↓ dose. Second occurrence: Hold niraparib for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100,000/mm³. Resume at a ↓ dose. Discontinue niraparib if platelet count has not returned to acceptable levels within 28 days of the dose interruption period or if dose already ↓ to 100 mg once daily. For platelet count ≤10,000/mm³/L, consider platelet transfusion. If other risk factors such as coadministration of anticoagulation or antiplatelet drugs exist, consider interrupting these drugs and/or transfusion. Resume therapy at a ↓ dose.
  • If neutrophil count <1000/mm³ or hemoglobin <8 g/dL, hold niraparib for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1500/mm³ or hemoglobin returns to ≥9 g/dL. Resume at a ↓ dose. Discontinue therapy if neutrophil count and/or hemoglobin have not returned to acceptable levels within 28 days of dose interruption or if dose already ↓ to 100 mg once daily.
  • May cause anemia.
  • May cause ↑ AST and ALT.