Most Hematologic ARs Occurred During the
First 3 Months of Therapy1
NOVA: Hematologic ARs reported in ≥10% of patients receiving ZEJULA2
The rate of grade ≥3 thrombocytopenia after cycle 3 was 2% in patients receiving ZEJULA.3
Abnormal laboratory findings (grades 1-4) in ≥25% of patients receiving ZEJULA2
- Decrease in hemoglobin (85%), decrease in platelet count (72%), decrease in white blood cell count (66%), decrease in absolute neutrophil count (53%), increase in AST (36%), and increase in ALT (28%)
Discontinuation Due to Hematologic ARs Was Uncommon2
- Hematologic ARs generally occurred within the first 3 treatment cycles; after dose adjustment on the basis of an individual adverse event profile, the incidence of grade 3/4 thrombocytopenia, neutropenia, or fatigue was infrequent beyond cycle 33
- 1 patient (<1%) in the ZEJULA arm experienced febrile neutropenia4
Low rates of treatment discontinuation were observed due to ARs2
- In the same clinical trial, 15% of the overall population discontinued treatment due to ARs2
Thrombocytopenia Was Typically Transient With Dose Modification3,4
Platelet levels decreased initially but showed stabilization after cycle 3 with appropriate dose modification3
- The median time to onset of grade 3/4 thrombocytopenia was 23 days in the ZEJULA treatment arm4
- Most grade 3/4 thrombocytopenia events were transient with dose interruption or dose reduction. The median duration was 10 days4
No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia.3
- All bleeding events associated with thrombocytopenia were grade 1/2; 1 patient had grade 3 petechiae and hematoma concurrent with a serious adverse event of pancytopenia
*Monitor periodically. Schedule provided as an example.
Non-Hematologic Adverse Reactions
The Side Effect Profile of ZEJULA Is Well-Characterized2
Adverse reactions (ARs) reported in ≥10% of patients receiving ZEJULA2
CTCAE, Common Terminology Criteria for Adverse Events, version 4.02.
ALT, alanine aminotransferase; AST, aspartate aminotransferase.
Side effects were manageable with dose interruption and modification.
- ARs led to dose reduction or interruption in 69% of patients, most frequently from thrombocytopenia (41%) and anemia (20%)2,3
- No increase in all-grade diarrhea was observed with ZEJULA vs placebo2
- No on-treatment deaths were reported during the study3
SE, standard error.
References: 1. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib. Ann Oncol. 2018;29(8):1784-1792. 2. ZEJULA (niraparib) [package insert]. Waltham, MA: GSK, Inc; October 2019. 3. Mirza MR, Monk BJ, Herrstedt J, et al; ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164, and Supplementary Appendix. 4. Data on file. TESARO, Inc.