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- 6.7% TEAE-related discontinuation vs 5.4% with placebo1
- 40.4% TEAE-related dose reductions vs 6.2% with placebo1
- 62.7% TEAE-related dose interruptions vs 19.4% with placebo1
PRIME Safety Profile
PRIME reinforced the manageable safety profile demonstrated in PRIMA, with no new safety signals for ZEJULA (niraparib)1-4
For a full list of Adverse Events and Special Warnings and Precautions please click here to view the Summary of Product Characteristics for Zejula
Incidence of TEAEs and impact on treatment with ZEJULA or placebo in the ITT population (N=384) after 27.5-month median follow-up:1
| TEAE | ZEJULA (n=255) |
Placebo (n=129) |
|---|---|---|
| Any grade ≥3 TEAE, % | 54.5 |
17.8 |
| Serious TEAE, % | 18.8 | 8.5 |
| Led to treatment discontinued, % | 6.7 | 5.4 |
| Led to dose reduction, % | 40.4 | 6.2 |
| Led to dose interruption, % | 62.7 | 19.4 |
| Led to death, % | 0.4 | 0 |
Figure adapted from Li N, et al. 2023.
ZEJULA should be discontinued in case of hypertensive crisis or if medically significant hypertension cannot be adequately controlled with anti-hypertensive therapy. For suspected MDS/AML or prolonged haematological toxicities, the patient should be referred to a haematologist for further evaluation. If MDS/AML is confirmed ZEJULA, treatment should be discontinued and the patient treated appropriately. In case of PRES, it is recommended to discontinue ZEJULA and to treat specific symptoms including hypertension.2
Please refer to the full SmPC for further information.
Find out more
ZEJULA (niraparib) is indicated5
- 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
AML, acute myeloid leukaemia; FIGO, Federation of Gynaecology and Obstetrics; ITT, intention-to-treat; MDS, myelodysplastic syndrome; PRES, posterior reversible encephalopathy syndrome; TEAE, treatment-emergent adverse event.
References
- Gonzàlez-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402;
- Gonzàlez-Martín A, et al. Eur J Cancer. 2023;189:112908;
- Li N, et al. JAMA Oncol. 2023;9(9):1230–1237;
- Yin R, et al. Abstract 551 presented at American Society of Clinical Oncology Annual Meeting 2022, 3–7 June, Chicago, IL;
- 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)
