Dose Adjustments

Once-daily Dosing and Appropriate Dose Modification Supports Long-term Treatment1

The starting dose of ZEJULA is 300 mg. Expect to interrupt dose and modify in ~50% of patients in the first month to quickly achieve the optimal dose.2

  • In the NOVA study, dose reductions tended to occur early, with most patients reaching their individually optimized dose at the end of month 3; only 28% of patients remained at a dose of 300 mg at month 4

ZEJULA is the only once-daily PARP inhibitor with 1 capsule strength for ease of dose modification1,3,4

  • In the NOVA study, dose reduction does not require an additional prescription or additional co-pay1
     

Interrupt treatment prior to dose adjustment1

In the NOVA Trial, the ZEJULA Dose for Each Patient Was Often Determined Within the First Few Months of Treatment2

  • The most commonly administered dose of ZEJULA in the NOVA trial was 200 mg/day5
  • 28% of patients remained at a dose of 300 mg at month 42

No starting dose adjustment necessary for1,6:

§There are no data in patients with severe renal impairment or end-stage renal disease undergoing hemodialysis.1
||There are no data in patients with moderate to severe hepatic impairment.1

AR, adverse reaction; AST, aspartate aminotransferase; CBC, complete blood count;  CrCl, creatinine clearance; ULN, upper limit of normal.

References: 1. ZEJULA (niraparib) [package insert]. Waltham, MA: TESARO, Inc.; February 2019. 2. Data on file. TESARO, Inc. 3. Rubraca (rucaparib) [package insert]. Boulder, CO: Clovis Oncology, Inc; April 2018. 4. Lynparza (olaparib) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2018. 5. 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. 6. 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. doi: 10.1200/JCO.2010.30.2307
 

Information on hematologic adverse reactions

HEMATOLOGIC ARs

See hematologic ARs

See Incidence Rates
Considerations for dose modification

"WEIGHTS AND PLATES" ANALYSIS

Identify patients likely to require early dose modification

See the Data
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