Dose Modifications
ZEJULA dose modifications to manage adverse reactions1
If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA and refer the patient to a hematologist for further investigation.
Resume at the same dose only for the first occurrence of thrombocytopenia if platelets are >75,000/μL.
Monitoring complete blood counts, blood pressure, and heart rate helps identify the need to dose modify1
Blood counts
1st month
1x a
week
Rest of year
1x a
month
After year 1‡
1x every
2-3 months
Blood pressure and heart rate
1st and 2nd month
1x a
week
Rest of year
1x a
month
After year 1‡
1x every
2-3 months
Monitor periodically. Schedule provided as an example.
No starting dose adjustment necessary for most special populations or conditions1
Dose adjustment
For Moderate Hepatic
Impairment§
Total bilirubin ≥1.5 x ULN to 3.0 x ULN and any AST level||
For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily.1
Monitor patients for hematologic toxicity and reduce the dose further, if needed.
For Moderate Hepatic
Impairment§
Total bilirubin ≥1.5 x ULN to 3.0 x ULN and any AST level||
For patients with moderate hepatic impairment, reduce the starting dosage of ZEJULA to 200 mg once daily.1
Monitor patients for hematologic toxicity and reduce the dose further, if needed.
No dose adjustment necessary1
For Food
Food does not significantly affect the absorption of niraparib
For Mild/Moderate Renal
Impairment¶
Mild: CLcr 60-89 mL/min
Moderate: CLcr 30-59 mL/min
For Mild Hepatic
Impairment||
Total bilirubin <1.5 x ULN and any AST level OR bilirubin ≤ULN and AST >ULN||
For Age
≥65 years
No dose adjustment necessary1
For Food
Food does not significantly affect the absorption of niraparib
For Mild/Moderate Renal
Impairment¶
Mild: CLcr 60-89 mL/min
Moderate: CLcr 30-59 mL/min
For Mild Hepatic
Impairment||
Total bilirubin <1.5 x ULN and any AST level OR bilirubin ≤ULN and AST >ULN||
For Age
≥65 years
There are no data in patients with severe hepatic impairment.
There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.
