See Important Safety Information below for combined NOVA and QUADRA safety profile
NOVA: Hematologic ARs
Most Hematologic ARs Occurred During the First 3 Months of Therapy1
Discontinuation Due to Hematologic ARs Was Uncommon2
Thrombocytopenia Was Typically Transient With Dose Modification3,4
Change in platelet levels from baseline over time3
No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia3
- 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
Incidence of grade 3/4 thrombocytopenia in the ZEJULA arm of the NOVA trial; treatment months 1-54
Monitoring complete blood counts, blood pressure, and heart rate will help identify the need to dose modify2
‡Schedule provided as an example.
ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; SE, standard error.
References: 1. Berek JS, Matulonis UA, Peen U, et al. Safety and dose modification for patients receiving niraparib [published online ahead of print, May 14, 2018]. Ann Oncol. 2018. doi: 10.1093/annonc/mdy181. 2. ZEJULA (niraparib) [package insert]. Waltham, MA: TESARO, 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, and Supplementary Appendix. N Engl J Med. 2016;375(22):2154-2164. 4. Data on file. TESARO, Inc.