NOVA Safety

Most Hematologic ARs Occurred During the
First 3 Months of Therapy1


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
 


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.

 

Information on hematologic adverse reactions


QUADRA SAFETY

See safety results for QUADRA

View ARs
Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing

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.