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
- 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 counts, blood pressure, and heart rate will help identify the need to dose modify1
‡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: GSK, Inc; October 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; July 2019. 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.