Dosing for Maintenance

The Convenience of Once-Daily Oral Dosing Supports Long-Term Maintenance Treatment1

  • Use as early as first recurrence, following complete or partial response (CR or PR) to platinum-based chemotherapy1
  • ZEJULA may be taken at any time of day, with or without food1
  • Once-daily dosing enables bedtime administration to help manage nausea1
  • Dose modification based on patient tolerability is conducive to long-term treatment1
  • Dose modification was shown not to compromise treatment efficacy2
Recommended dose modifications for adverse reactions:
Dose reduction does not require an additional prescription or additional co-pay1
Recommended dose modifications for Adverse Reactions

Starting dose
300 mg/day
(Dose = 3 x 100-mg capsules)

Recommended dose modifications for Adverse Reactions

First dose reduction
200 mg/day
(Dose = 2 x 100-mg capsules)

Recommended dose modifications for Adverse Reactions

Second dose reduction
100 mg/daya
(Dose = 1 x 100-mg capsule)

a If dose reduction below 100 mg/day is required, discontinue ZEJULA.

Dose modification based on patient tolerability allows for long-term treatment1

  • Interrupt and then modify the dose for non-hematologic adverse reactions (ARs) of CTCAE grade ≥3 when prophylaxis is not considered feasible or when ARs persist despite treatment1
  • Interrupt and then modify the dose for hematologic ARs requiring transfusion or for thrombocytopenia (platelet count <100,000/μL), grade ≥3 neutrophil count <1,000/μL, or grade ≥3 hemoglobin count <8 g/dL1,3
  • ZEJULA may be withheld for a maximum of 28 days as part of an adverse reaction management strategy1
  • Resume at same or reduced dose immediately after resolution of toxicity1

CTCAE, Common Terminology Criteria for Adverse Events.

 

In the NOVA trial, the ZEJULA Dose for Each Patient Was Often Determined Within the First Few Months of Treatment4

 

For patients starting at a 300-mg dose, expect to dose interrupt and modify in approximately 50% of patients in the first month to quickly achieve the optimal dose

  • Dose reductions tended to occur early, with most patients reaching their individual adjusted dose level at the end of month 3
  • The most commonly administered dose of ZEJULA in the NOVA trial was 200 mg/day
  • 28% of patients remained at a dose of 300 mg at month 4

Efficacy Was Not Shown to Be Compromised by Dose Reductions2

A subgroup analysis showed that the efficacy was maintained after dose modification2

  • This subgroup analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup2
  • Patients experienced similar efficacy at their individual maximum-tolerated dose2
  • Interrupt and reduce dose at the first sign of unacceptable toxicity1

No starting dose adjustment necessary for1:

No starting dose adjustment necessary for mild/moderate renal impairment

Mild/moderate renal impairmenta
Mild: CrCl; 60 to 89 mL/min
Moderate: CrCl: 30 to 59 mL/min

No starting dose adjustment necessary for mild hepatic impairment

Mild hepatic impairmentb
≤1.5 x ULN total bilirubin OR
>ULN AST with normal bilirubin5

No starting dose adjustment necessary for patients ≥65 years

Elderly
Patients ≥65 years old

a There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.
b There are no data in patients with moderate to severe hepatic impairment.

AST, aspartate aminotransferase; CrCl, creatinine clearance; ULN, upper limit of normal.

References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Wang J, Zhang Z-Y, Mirza MR, et al. The exposure-response relationship of niraparib patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA trial. Presented at: European Society for Medical Oncology Congress; September 8-12, 2017; Madrid, Spain. 3. National Cancer Institute. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-14_QuickReference_8.5x11.pdf. Published May 28, 2009. Accessed December 28, 2017. 4. Data on file. TESARO, Inc. 5. Ramalingam SS, Kummar S, Sarantopoulos J, et al. Phase I study of vorinostat in patients with advanced solid tumors and hepatic dysfunction: a National Cancer Institute Organ Dysfunction Working Group study. J Clin Oncol. 2010;28(29):4507-4512.  

Dose modification

DOSE MODIFICATION

Identify patients who may require an early dose modification

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Safety data

SAFETY DATA

Learn about the safety and tolerability of ZEJULA

See Safety

AR monitoring

AR MONITORING

How should I monitor for hematologic ARs with ZEJULA?

View Guidelines

Dose modification

EFFICACY SUMMARY

See the clinical efficacy summary for ZEJULA

See Summary