Dose Modifications

ZEJULA dose modifications to manage adverse reactions1

ZEJULA (niraparib) dose modifications
ZEJULA (niraparib) dose modifications

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§

Moderate hepatic impairment icon

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.

Moderate hepatic impairment icon

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
 

Meal icon

Food does not significantly affect the absorption of niraparib

For Mild/Moderate Renal
Impairment

Mild/moderate renal impairment icon

Mild: CLcr 60-89 mL/min
Moderate: CLcr 30-59 mL/min

For Mild Hepatic
Impairment||

Moderate hepatic impairment icon

Total bilirubin <1.5 x ULN and any AST level OR bilirubin ≤ULN and AST >ULN|

For Age
 

Greater than or equal to 65 icon

≥65 years

No dose adjustment necessary1

Meal icon

For Food
 

Food does not significantly affect the absorption of niraparib

Mild/moderate renal impairment icon

For Mild/Moderate Renal
Impairment

Mild: CLcr 60-89 mL/min
Moderate: CLcr 30-59 mL/min

Moderate hepatic impairment icon

For Mild Hepatic
Impairment||

Total bilirubin <1.5 x ULN and any AST level OR bilirubin ≤ULN and AST >ULN|| 

Greater than or equal to 65 icon

For Age
 

≥65 years

There are no data in patients with severe hepatic impairment.

As defined by the National Cancer Institute - Organ Dysfunction Working Group (NCI-ODWG) criteria.

There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.