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Prescribing information

Introducing ZEJULA tablets

ZEJULA is now available in a tablet formulation, which is bioequivalent to, and interchangeable with, ZEJULA capsules.*^†1

At GSK, we are committed to supporting your transition from capsules to tablets: explore the brochures below for you, your clinic and your patients.

Switching your patients to the ZEJULA tablet formulation

Ensure a smooth transition

Learn how to switch your patients from capsules to tablets and ensure a smooth transition

CLICK HERE

Get in touch with GSK for more information

All imagery shown depicts hypothetical patients only.

*In a pharmacokinetic study with 108 patients with solid tumours, under fasting conditions, one 300 mg tablet was bioequivalent to three 100 mg capsules, based on plasma concentration of niraparib.¹ For more information on these data, please refer to the Summary of Product Characteristics.

^†ZEJULA capsules can be taken without regard to meals. It is advised to take ZEJULA tablets without food (at least 1 hour before or 2 hours after a meal) or with a light meal.¹

Zejula Safety Information¹:

Contraindications:
Hypersensitivity to the active substances or to any of the excipients.

Special warnings and precautions:
Haematologic adverse reactions (thrombocytopenia, anaemia, neutropenia) have been reported. Discontinue if a patient develops severe persistent haematologic toxicity including pancytopenia that does not resolve within 28 days following interruption.
Use with caution in patients on anticoagulants and medicinal products known to reduce the thrombocyte count hypertension, hepatic impairment.

Pregnancy/contraception:
Should not be used during pregnancy.

Adverse Events:
Very common: Urinary Tract Infections, thrombocytopenia, anaemia, neutropenia, leukopenia, decreased appetite, insomnia.

Please refer to the local prescribing information for a more detailed safety information.

Abbreviations

FIGO, International Federation of Gynecology and Obstetrics.

References

ZEJULA (niraparib) Prescribing information.

For more information, please refer to the prescribing information or contact GlaxoSmithKline via gcc.medinfo@gsk.com
To report Adverse Event/s associated with the use of GSK product/s, please contact us via
gulf.safety@gsk.com
To report quality complaint/s associated with the use of GSK product/s, please contact us via
Gulf.ProductQualityComplaints@gsk.com

Department of Pharmacovigilance & Drug Information
Drug Safety Center
Ministry of Health, Sultanate of Oman
Phone Nos. 0096822357687 / 0096822357690
Fax: 0096822358489
Email: pharma-vigil@moh.gov.om
Website: www.moh.gov.om

دائرة التيقظ و المعلومات الدوائية
مركز سلامة الدواء
وزارة الصحة, سلطنة عمان
هاتف: 0096822357687 / 0096822357690
0096822358489 :فاكس
pharma-vigil@moh.gov.om :البريد االكتروني
www.moh.gov.om : الموقع االكتروني

PM-RCH-NRP-SRCH-240001 | August 2024