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NOVA Safety

Most Hematologic ARs Occurred During the
First 3 Months of Therapy1
 

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.5

  • 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 pancytopenia5
     

*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
  • No increase in all-grade diarrhea was observed with ZEJULA vs placebo5
  • No on-treatment deaths were reported during the study5
ALT, alanine aminotransferase; AR, adverse reaction; AST, aspartate aminotransferase; SE, standard error.

 

Safety data


QUADRA SAFETY

See safety results for QUADRA

View Adverse Reactions
ZEJULA (niraparib) 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). Prescribing Information. GlaxoSmithKline; 2020. 3. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer [supplementary index]. N Engl J Med. 2016;375(22):2154-2164. 4. Data on file, GlaxoSmithKline. 5. Mirza MR, Monk BJ, Herrstedt J, et al; for the ENGOT-OV16/NOVA Investigators. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375(22):2154-2164.