Table 3.

Hematological adverse events grading and management

Hematologic*: obtain complete blood counts weekly for the first month, monthly for the next 11 months, and periodically thereafter for clinically significant changes
Adverse event	Grade	Management
Anemia	Grade 1 Hgb <LLN−10.0 g/dL; <LLN−6.2 mmol/L; <LLN–100 g/L	If hemoglobin <8 g/dL: Withhold niraparib for a maximum of 28 days and monitor blood counts weekly until hemoglobin returns to ≥9 g/dL Resume niraparib at a reduced dose per label-recommended dose modifications† for hematologic toxicity20 37 Discontinue niraparib if hemoglobin has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg once daily
	Grade 2 Hgb <10.0–8.0 g/dL; <6.2–4.9 mmol/L; <100–80 g/L
	Grade 3 Hgb <8.0 g/dL; <4.9 mmol/L; <80 g/L; transfusion indicated
	Grade 4 Life-threatening consequences; urgent intervention indicated
Platelet count	Grade 1 <LLN–75 000/mm3; <LLN−75.0x109 /L	If platelet count is <100 000/μL: First occurrence: Withhold niraparib for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100 000/µL Resume niraparib at same or reduced dose per label-recommended dose modifications† for hematologic toxicity20 37 If platelet count is <75 000/μL, resume at a reduced dose Second occurrence: Withhold niraparib for a maximum of 28 days and monitor blood counts weekly until platelet counts return to ≥100 000/µL Resume niraparib at a reduced dose per label-recommended dose modifications Discontinue niraparib if the platelet count has not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100 mg once daily
	Grade 2 <75 000–50 000/mm3; <75.0–50.0x109/L
	Grade 3 <50 000–25 000/mm3; <50.0–25.0x109/L
	Grade 4 <LLN–75 000/mm3; <LLN−75.0x109/L
Neutrophil count	Grade 1 <LLN–1500/mm3;<LLN−1.5x109/L	If neutrophil count is <1000/μL: Withhold niraparib for a maximum of 28 days and monitor blood counts weekly until neutrophil counts return to ≥1500/µL Resume niraparib per label-recommended dose modifications† for hematologic toxicity Discontinue niraparib if neutrophils have not returned to acceptable levels within 28 days of the dose interruption period, or if the patient has already undergone dose reduction to 100mg once daily*
	Grade 2 <1500–1000/mm3 ; <1.5–1.0x109 /L
	Grade 3 <1000–500/mm3 ; <1.0–0.5x109 /L
	Grade 4 <500/mm3 ; <0.5×109 /L

*If myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) is confirmed, discontinue niraparib.

†For 200 mg starting dose: first dose reduction is to 100 mg/day (one 100 mg capsule); if a second dose reduction is needed, discontinue treatment. For 300 mg starting dose: first dose reduction is to 200 mg/day (two 100 mg capsules), second dose reduction is to 100 mg/day (one 100 mg capsule); if dose reductions <100 mg/day are required, discontinue treatment.

Hgb, hemoglobin; LLN, lower limit of normal.