Hematologic AR Incidence

Hematologic Adverse Reactions Were Reported but Were Typically Manageable With Dose Reduction1

Abnormal laboratory findings (grades 1-4) in ≥25% of patients receiving ZEJULA1
  • 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%)

ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase.

Rate of grade ≥3 ARs after cycle 3 in patients receiving ZEJULA2

Low Rates of Treatment Discontinuation Were Observed1,2

  • In the clinical trial, 15% of the overall population discontinued treat due to ARs
  • 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

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. 

Dose Modification


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