- No clinically significant bleeding events (grade ≥3) were associated with thrombocytopenia2
- All bleeding events associated with thrombocytopenia were grade 1 or 2; 1 patient had grade 3 petechiae and hematoma concurrent with a serious adverse event of pancytopenia
a Thrombocytopenia and decreased platelet count.2b Anemia and decreased hemoglobin count.2c Neutropenia, decreased neutrophil count, and febrile neutropenia.2d Fatigue, asthenia, malaise, and lethargy.2AR, adverse reaction.
Low Rates of Treatment Discontinuation Were Observed1,2
- In the clinical trial, 15% of the overall population discontinued treat due to ARs
Discontinuation due to hematologic ARs was uncommon1,2
AR, adverse reaction.
- Hematologic ARs generally occured 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 32
- Only 1 patient (<1%) in the ZEJULA arm experienced febrile neutropenia3
Thrombocytopenia Was Typically Transient With Dose Modification2
Platelet levels decreased initially but showed stabilization after cycle 3 with appropriate dose modification2
- Among patients treated with ZEJULA, the media time to onset of grade 3/4 thrombocytopenia was 23 days3
- Most grade 3/4 thrombocytopenia events were transient with dose interruption or dose reduction, and the median duration was 10 days3
Change in platelet levels from baseline over time2
SE, standard error.
Incidence of grade 3/4 thrombocytopenia in the ZEJULA arm of the NOVA trial; treatment months 1-53
References: 1. ZEJULA [package insert]. Waltham, MA: TESARO, Inc; 2017. 2. 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. 3. Data on file. TESARO, Inc.