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ZEJULA (niraparib) Monitoring and AE Management

Monitoring complete blood counts and blood pressure will identify the need for dose interruption, dose modification and treatment discontinuation with ZEJULA1

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

Regularly monitoring your patients complete blood counts and blood pressure will help identify the need for dose interruption, dose modification and treatment discontinuation with ZEJULA.1

Testing complete blood counts weekly for the first month, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended to monitor for clinically significant changes in any haematologic parameter during treatment (see section 4.2 of the SmPC); blood pressure should be monitored at least weekly for two months, monitored monthly afterwards for the first year and periodically thereafter during treatment with ZEJULA; a pregnancy test should be performed on all women of childbearing potential prior to treatment.1
For guidance regarding dose interruption, dose modification, and treatment discontinuation, please refer to the SmPC.

Complete blood count monitoring1

Infographic showing example of blood count monitoring schedule

Please refer to the SmPC when making prescribing decisions. The information provided here is to supplement understanding rather than replace advice in the SmPC.1

Blood pressure monitoring1

Infographic showing example of blood pressure monitoring schedule

Please refer to the SmPC when making prescribing decisions. The information provided here is to supplement understanding rather than replace advice in the SmPC.1

Management of adverse reactions should follow the guidance provided in the ZEJULA SmPC1

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SEE PRIMA SAFETY PROFILE

ZEJULA (niraparib) is indicated1

  • 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 event; AML, acute myeloid leukaemia; FIGO, Federation of Gynaecology and Obstetrics; MDS, myelodysplastic syndrome; PRES, posterior reversible encephalopathy syndrome; SmPC, A Summary of Product Characteristic.

References

  1. 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)