Once-Daily Oral Dosing Supports Maintenance Treatment1

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

  • Interrupt and then modify the dose for non-hematologic ARs of CTCAE grade ≥3 when prophylaxis is not considered feasible or when ARs persist despite treatment
  • 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/dL
  • Resume at same or reduced dose immediately after resolution of toxicity

Recommended dose modifications for ARs:
dose reduction does not require a new prescription or additional co-pay1

Recommended dose modifications for Adverse Reactions
a If dose reduction below 100 mg/day is required, discontinue ZEJULA.
AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events.

ZEJULA Dose for Each Patient Is Often Determined Within the First Few Months of Treatment2

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 dose2

  • Dose reductions tended to occur early, with most patients reaching their individual adjusted dose level at the end of month 3

Dose level by month on treatment

Dose level by month on treatment
  • The most commonly administered dose of ZEJULA in the NOVA trial was 200 mg/day2

  • Only 28% of patients remained at a dose of 300 mg at month 42

 

Efficacy Was Not Shown to Be Compromised by Dose Reductions for ARs2,3

A subgroup analysis showed that efficacy was maintained after dose modification2,3

  • 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 dose2,3
  • Interrupt and reduce dose at the first sign of unacceptable toxicity1

Estimated PFS probability by dose level measured after cycle 3 in BRCAmut2,3

Graph showing estimated PFS probability by dose level measured after cycle 3 in BRCAmut

Estimated PFS probability by dose level measured after cycle 3 in BRCA wild type2,3

Graph showing estimated PFS probability by dose level measured after cycle 3 in BRCA wild type

 

Once-Daily Oral Dosing Supports Maintenance Treatment1

Convenient dosing for long-term treatment1

  • Use as early as first recurrence, following CR or PR to platinum-based chemotherapy
  • ZEJULA may be taken at any time of day, with or without food
  • Once-daily dosing enables bedtime administration to help manage nausea
  • Dose modification based on patient tolerability is conducive to long-term treatment

No starting dose adjustment necessary for1

Mild/moderate renal impairmenta

No starting dose adjustment necessary for mild/moderate renal impairment

Mild:

CLcr: 60 to 89 mL/min

Moderate:
CLcr: 30 to 59 mL/min

Mild hepatic impairmentb

No starting dose adjustment necessary for mild hepatic impairment

≤1.5 × ULN total bilirubin
OR
>ULN AST with normal bilirubin

Elderly
 

No starting dose adjustment necessary for patients ≥65 years

Patients ≥65 years

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; CLcr, creatinine clearance; CR, complete response; PARP, poly(ADP-ribose) polymerase; PR, partial response; ULN, upper limit of normal
ZEJULA® dosing guide

For complete information on dose adjustments, download ZEJULA’s detailed Dosing Guide or see section 2.2 of the full Prescribing Information.

Download

Please see Important Safety Information below and full Prescribing Information.

Access additional resources

Reference: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. Data on file. TESARO, Inc. 3. Wang J et al. Poster presented at: 42nd European Society for Medical Oncology Congress; September 8-12, 2017; Madrid, Spain. Abstract 933PD.