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
*If hematological toxicities do not resolve within 28 days following interruption, discontinue ZEJULA and refer the patient to a hematologist for further investigation.1
†Resume at the same dose only for the first occurrence of thrombocytopenia if platelets are >75,000/μL.1
AR, adverse reaction; CTCAE, Common Terminology Criteria for Adverse Events.
Monitoring complete blood counts2
‡Schedule provided as an example.
Dose level by month on 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