ZEJULA (niraparib) logo

Product menu

Fictious Healthcare Professional

PRIMA reported TEAEs

In PRIMA, ZEJULA (niraparib) had a manageable safety profile, maintained during 3.5 years of median follow-up1,2

For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for Zejula

TEAEs reported in ≥20% of patients in PRIMA treated with ZEJULA or placebo in the overall population (N=728) after 3.5-year median follow-up:1

Graph showing AEs reported in patients in PRIMA in overall population

Adapted from González-Martín A, et al. 2023.

*Includes thrombocytopenia and platelet count decreased.
†Includes anaemia, haemoglobin decreased, red blood cell decreased, haematocrit decreased, and anaemia macrocytic.
‡Includes neutropenia, neutrophil count decreased, febrile neutropenia, and neutropenic sepsis.
§Includes hypertension, blood pressure increased, and blood pressure fluctuation.

TEAEs in the ZEJULA arm after 3.5 years of follow-up in the PRIMA trial vs the primary analysis:1,2

  • Four additional patients experienced grade ≥3 thrombocytopenia
  • Three additional patients experienced grade ≥3 anaemia
  • Three additional patients experienced grade ≥3 neutropenia

In PRIMA, no new safety signals were reported after 3.5-years of follow-up1

MDS or AML events were reported in the same proportion of patients in the ZEJULA (1.2%) and placebo (1.2%) arms1 Zejula should be discontinued if:

  • Severe persistent hematologic toxicity including pancytopenia develops that does not resolve within 28 days of interruption
  • Confirmed diagnosis of MDS and/or AML. The patient should be treated appropriately

For Further Information on discontinuations, please refer to the Zejula SmPC

No new safety signals were identified in the 3.5-year median follow-up results1

ZEJULA is associated with a manageable rate of serious TEAEs1

TEAEs reported in ≥20% of patients in PRIMA with ZEJULA individualised starting dose or placebo after 3.5-year median follow-up:1,*

Graph showing AEs reported in patients in PRIMA in individualised starting dose population

Adapted from González-Martín A, et al. 2023.

*Data shown for the overall placebo population; results were similar in patients who received placebo as a fixed or individualised starting dose.
†Includes thrombocytopenia and platelet count decreased.
‡Includes anaemia, haemoglobin decreased, red blood cell decreased, haematocrit decreased, and anaemia macrocytic.
§Includes neutropenia, neutrophil count decreased, febrile neutropenia, and neutropenic sepsis.
Includes hypertension, blood pressure increased, and blood pressure fluctuation.

Learn more about an individualised starting dose with ZEJULA

Read more

See Monitoring and AE Management

Find out more

PRIMA study design

PRIMA efficacy

ZEJULA QoL

ZEJULA (niraparib) is indicated3

  • as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
  • as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Abbreviations

AE, adverse events; TEAE, treatment-emergent adverse event.

References

  1. Gonzàlez-Martín A, et al. Eur J Cancer. 2023;189:112908
  2. González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
  3. Zejula (niraparib) Summary of product characteristics (Last Accessed: May 2024).

Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk (UK) or search for MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to GSK Limited on 0800 221 441 or by email at uksafety@gsk.com.

©2024 GSK Group of Companies or its licensor. Trademarks are the property of their respective owners.

May 2024 | PM-GB-NRP-WCNT-220021 (V2.0)