NOVA Safety

Most Hematologic ARs Occurred During the
First 3 Months of Therapy1

NOVA: Hematologic ARs reported in ≥10% of patients receiving ZEJULA2

Chart showing the incidence of hematologic adverse reactions in greater than or equal to 10% of patients receiving ZEJULA (niraparib)
Chart showing the incidence of hematologic adverse reactions in greater than or equal to 10% of patients receiving ZEJULA (niraparib)

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 Uncommon

Table depicting percentage rate of discontinuation of ZEJULA (niraparib) due to various hematologic adverse reactions
Table depicting percentage rate of discontinuation of ZEJULA (niraparib) due to various hematologic adverse reactions
  • 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

Change in platelet levels from baseline over time3

Graph showing change in platelet levels from baseline over time
Graph showing change in platelet levels from baseline over time

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

Incidence of grade 3/4 thrombocytopenia in the ZEJULA arm of the NOVA trial; treatment months 1-54

Graph showing incidence of grade 3/4 thrombocytopenia in the ZEJULA (niraparib) arm of the NOVA trial
Graph showing incidence of grade 3/4 thrombocytopenia in the ZEJULA (niraparib) arm of the NOVA trial

Monitoring complete blood counts, blood pressure, and heart rate will help identify the need to dose modify2

Knowledge card with information about monitoring the blood count, blood pressure and heart rate for ZEJULA (niraparib) patients
Knowledge card with information about monitoring the blood count, blood pressure and heart rate for ZEJULA (niraparib) patients

*Monitor periodically. Schedule provided as an example.

Non-Hematologic Adverse Reactions

The Side Effect Profile of ZEJULA Is Well Characterized2 

Adverse reactions (ARs) reported in ≥10% of patients receiving ZEJULA2 

Chart showing the side effect profile of ZEJULA (niraparib), as reported in greater than or equal to 10% of patients
Chart showing the side effect profile of ZEJULA (niraparib), as reported in greater than or equal to 10% of patients

CTCAE, Common Terminology Criteria for Adverse Events, version 4.02.

ALT, alanine aminotransferase; AST, aspartate aminotransferase.

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.

quadra safety

See safety results for
QUADRA

Dose
Modifications

See recommendations for dose adjustments

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; 2021. 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.