Weights and Plates

Find the Right Dose for Your Patients Based on “Weights and Plates”1

This exploratory analysis of the NOVA trial was conducted to identify patients most likely to require an early dose modification.1

The only 2 predictors of early dose modification to 200 mg or 100 mg were1:

For patients with at least one of these two predictors2:

  • Approximately 90% were dose reduced by month 6

Efficacy Was Not Shown to Be Compromised by Dose Reductions for ARs

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 subgroup.4

  • Patients experienced similar efficacy at their individual maximum-tolerated dose3
  • Interrupt and reduce dose at the first sign of unacceptable toxicity5

ZEJULA Side Effects Typically Can Be Managed With Dose Interruption and Modification1,5

  • In NOVA, all patients started on a 300-mg dose of ZEJULA5
  • Adverse reactions led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%)5

After dose modification, ZEJULA showed long-term tolerability in NOVA, including patients receiving treatment for >3 years6

A long-term safety analysis of the NOVA study assessed the incidence of TEAEs in patients receiving ZEJULA for up to 4 years. Of the initial 367 patients in the ZEJULA treatment group and 179 in the placebo treatment group, 18.8% and 5.6% of patients were included in the 2- to 4-year evaluation period, respectively.

AR, adverse reaction; BRCAmut, breast cancer susceptibility gene mutated; PFS, progression-free survival.

References: 1. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018 Aug 13. doi: 10.1093/annonc/mdy255. 2. Moore KN et al. The poly (ADP ribose) polymerase inhibitor niraparib: management of toxicities. Gynecol Oncol. 2018;149(1):214-220. doi: 10.1016/j.ygyno.2018.01.011. 3. Wang J, Zhang Z-Y, Mansoor R, et al. The exposure-response relationship of niraparib in patients with gBRCAmut and non-gBRCAmut: results from the ENGOT-OV16/NOVA Trial. Poster presented at: Annual Congress of the European Society for Medical Oncology; September 8-12, 2017; Madrid, Spain. Poster 933PD. 4. Data on file. TESARO, Inc. 5. ZEJULA (niraparib) [package insert]. Waltham, MA: TESARO, Inc.; February 2019. 6. Mirza MR, Benigno B, Dørum A, et al. Long-term safety of niraparib in patients with recurrent ovarian cancer: results from the ENGOT-OV16/NOVA trial. Presented at: 17th Biennial Meeting of the IGCS; September 15, 2018; Kyoto, Japan.

Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing
Information on hematologic adverse reactions

HEMATOLOGIC ARs

See hematologic ARs

See Incidence Rates
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