Hematologic ARs

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 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 and subsequent dose reduction. The median duration was 10 days4

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
     

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.; February 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.

Information on non-hematologic adverse reactions

NON-HEMATOLOGIC ARs

See non-hematologic ARs

Review ARs
Dosing information

DOSE MODIFICATIONS

See recommendations for dose adjustments

Review Dosing
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