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Quality of life
Explore how quality of life was maintained with ZEJULA1–3
Patient Experience
HRQoL was maintained for over 30 months, comparable to placeboa7
ZEJULA maintained quality of life in patients with advanced ovarian cancer2,7,8
aExploratory analysis (data cut-off: primary analysis), results should be interpreted with caution. FOSI is a validated eight-item measure of symptom response to treatment, including lack of energy, vomiting, pain, nausea, stomach swelling, worsening condition, quality of life as assessed by the patient, and cramps in the stomach area. In PRIMA each treatment ‘month’ lasted 28 days.
HRQoL preserved vs. placebo, with delayed disease progressiona1
Patients on ZEJULA remained symptom and AE-free for longer than those treated with placeboa1
With preserved HRQoL and improved PFS, your patients may have the opportunity to make the most of their time on maintenancea,3
aPost hoc analysis. Q-TWiST analyses were performed at the last PFS of patients randomised to ZEJULA (27.8 months). TOX included Grade ≥2 AEs of interest (fatigue or asthenia, nausea, vomiting, abdominal pain and abdominal bloating).1
Comparable fatigue vs. placeboa3
Similar PROs for pain, physical functioning and QoL were reported between treatment armsa3
Offer your patients a 1L maintenance treatment that demonstrated no compromise to quality of lifea3
aExploratory analysis, results should be interpreted with caution. In PRIMA each treatment ‘month’ lasted 28 days.
With ZEJULA 1L maintenance, offer:4
Once-daily dosing
An infusion-free oral regimen
A tailored starting dose
ZEJULA can be taken:4
Without food or with a light meala
At home, or on the go
At any time of day or nightb
aEither 1 hour before, or 2 hours after a full meal.
bPatients should take ZEJULA at approximately the same time each day.4
With ZEJULA, they can plan their treatment around their lives, not their lives around their treatment†1,3,4,7
†With routine monitoring.
Tailor your patient’s dose of ZEJULA, right from the start‡2,4,8,9
Starting dose:4
If baseline weight: <77 kg, or platelets <150,000/μl
Starting dose:4
If baseline weight: ≥77 kg, and platelets ≥150,000/μl
ZEJULA efficacy was maintained, even with individualised starting dosing§4,8,9
‡The ZEJULA starting dose for 1L maintenance is 200 mg/day if baseline weight is <77 kg or platelets <150,000/μl, and 300 mg/ day if baseline weight is ≥77 kg and platelets ≥150,000/μl. No dose adjustment is needed in patients with mild hepatic impairment (either AST >ULN and TB ≤ULN, or any AST and TB >1.0–1.5x ULN). For patients with moderate hepatic impairment (any AST and TB >1.5–3.0x ULN) the recommended starting dose of ZEJULA is 200 mg once daily. There are no data in patients with severe hepatic impairment (any AST and TB >3x ULN); use with caution in these patients.4
§Exploratory analyses, results should be interpreted with caution.
Monitor blood counts, heart rate and blood pressurea4
aPlatelets: ≥100,000/μL; neutrophils: ≥1,500/μL; haemoglobin ≥9 g/dL.
bOnly resume ZEJULA at the same dose if platelet count is ≥75,000/μL. If platelet count is <75,000/μL at any time, resume at a reduced dose.
With monitoring and management, you can help ensure they receive the right dose for them4
aIf there are other risk factors for bleeding such as co-administration of anticoagulation or antiplatelet medicinal products, consider interrupting these substances and/or transfusion at a higher platelet count.
bPlatelets: ≥100,000/μL; neutrophils: ≥1,500/μL; haemoglobin ≥9 g/dL.
cOnly resume ZEJULA at the same dose if platelet count is ≥75,000/μL. If platelet count is <75,000/μL at any time, resume at a reduced dose.
With monitoring and management, you can help ensure they receive the right dose for them4
Learn more about how ZEJULA impacts the patient experience
Hear from Dr Bradley Monk, MD, FACOG, FACS, on his perspectives regarding quality of life, dosing and more on the patient experience with ZEJULA
| Concomitant medication |
ZEJULA4 |
Olaparib10 |
Rucaparib11 |
|---|---|---|---|
| Strong and moderate CYP3A inhibitors or inducers E.g., certain antibiotics, antifungals, antiretroviral therapies, cardiovascular medication; certain fruits and juices |
No dose adjustment required, however caution recommended | Co-administration not recommendeda | No dose adjustment required, however caution recommended |
| Substrates including OATP1B1, OCT1, OCT2, OAT3, MATE1, and MATE2K E.g., certain antirheumatic, cardiovascular, cholesterol-lowering or diabetes medications |
No dose adjustment required | No dose adjustment required, however caution recommended | No dose adjustment required, however caution recommended |
| No dose adjustment required | Clinical monitoring recommended | No dose adjustment required, however caution recommended |
No known dietary restrictions with ZEJULA:4
- Can be taken without food or with a light meal, including grapefruitb
aDose reduce if a CYP34A inhibitor must be co-administered.
bEither 1 hour before, or 2 hours after a full meal.
ZEJULA may not interfere with patients’ other medications4
¶Based on in vivo data. No clinical drug interaction studies have been performed with ZEJULA.4
ZEJULA is now available in a tablet formulation4
ZEJULA tablets and capsules are interchangeable.||4 Therefore, there should be no change to how you treat your patients with ZEJULA#
||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.4 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.4
Learn more about ZEJULA in 1L maintenance
All imagery shown depicts hypothetical patients only.
Zejula Safety Information4:
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 or in women of childbearing potential.
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
1L, first-line; AST, aspartate aminotransferase; CYP, cytochrome P450; FIGO, International Federation of Gynecology and Obstetrics; FOSI, Functional Assessment of Cancer Therapy Ovarian Cancer Symptom Index; MATE, multidrug and toxin extrusion; OAT, organic anion transporter; OATP1B1, organic anion transporting polypeptides 1B1; OCT, organic cation transporter; PFS, progression-free survival; P-gp, P-glycoprotein; PRO, patient-reported outcome; Q-TWiST, Quality-adjusted Time Without Symptoms of Disease or Toxicity; TB, total bilirubin; TEAE, treatment-emergent adverse event; TOX, time prior to progression when patients experienced Grade ≥2 adverse events of interest; ULN, upper limit of normal.
References
- Barretina-Ginesta M-P, et al. Ther Adv Med Oncol. 2022;14:1–13.
- González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402.
- Halla K, et al. Safety and patient-reported outcomes in patients receiving niraparib in the PRIMA/ ENGOT-OV26/GOG-3012 Trial. Oncology Nursing Society (ONS) Annual Congress; San Antonio, TX, USA, 29 April–3 May 2020. Poster abstract IGCS20_1131.
- ZEJULA (niraparib) Prescribing information.
- Tookman L, et al. Ther Adv Med Oncol. 2020;12:1–14.
- Wethington SL, et al. VOCAL (Views of Ovarian Cancer Patients – How Maintenance Therapy Affects their Lives) Study: Patient Preference for Treatment Formulation and Administration. Poster presented at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting; New York City, NY, USA, 29 September–1 October 2022. Abstract 854.
- González-Martín A, et al. N Engl J Med. 2019;381(25):2391–2402. Supplementary appendix.
- Mirza MR, et al. Cancer. 2023;129(12):1846–1855.
- Gonzalez-Martin A, et al. Eur J Cancer. 2023; 189:112908.
- Lynparza (olaparib). Summary of Product Characteristics.
- Rubraca (rucaparib). Summary of Product Characteristics.
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 |
دائرة التيقظ و المعلومات الدوائية المديرية العامة للصيدلة و الرقابة الدوائية وزارة الصحة, سلطنة عمان 0096822357687 / 0096822357686 :هاتف 0096822358489 :فاكس pharma-vigil@moh.gov.om :البريد الالكتروني www.moh.gov.om :الموقع الالكتروني |
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