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ZEJULA (niraparib) once-daily oral dosing is convenient for your patients1

Recommended dosing

Once daily icon

Once-daily oral monotherapy1

Time icon

Taken any time
of the day*1

Food icon

Take without food (at least 1 hour before or 2
hours after a meal) or with a light meal1

*ZEJULA should be taken at approximately the same time each day.1

Individualised starting dose

ZEJULA (niraparib) is approved in first-line maintenance for advanced ovarian cancer with an individualised starting dose, based on baseline weight and platelet count1

If weight <77 kg or baseline platelets <150,000/μL1

ZEJULA ▼ (niraparib) 200mg/day doing image ZEJULA ▼ (niraparib) 200mg/day doing image

Or, if weight ≥77 kg and baseline platelets ≥150,000/μL, the recommended starting dose of ZEJULA is 300 mg/day1

For patients with moderate hepatic impairment†, the recommended starting dose of ZEJULA is 200 mg once daily, regardless of body weight1

Please read the Summary of Product Characteristics for all dosing recommendations and other considerations1
†Moderate hepatic impairment is defined as any AST and TB > 1.5 x - 3 x ULN

See how ZEJULA’s individualised starting dose can reduced AEs vs a fixed dose

EXPLORE INDIVIDUALISED STARTING DOSE

Efficacy is maintained with the individualised starting dose of ZEJULA, regardless of biomarker status1-3

This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

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PFS in the HRd population(n=373)4

57% icon

reduction in risk of progression or death with ZEJULA vs placebo
HR: 0.43 (95% CI: 0.31-0.59), p<0.0001

PFS in HRd patients taking an individualised starting dose based on weight and platelet count‡3

61% icon

reduction in risk of progression or death with ZEJULA vs placebo
HR: 0.39 (95% CI: 0.22-0.72)

‡This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

PFS in the HRd BRCAmut population (n=223)4,5

60% icon

reduction in risk of progression or death with ZEJULA vs placebo4,5
HR: 0.40 (95% CI: 0.27-0.62)

PFS in BRCAmut patients taking an individualised starting dose based on weight and platelet count‡2

71% icon

reduction in risk of progression or death with ZEJULA vs placebo‡2
HR: 0.29 (95% CI: 0.13-0.67)

‡This analysis is exploratory in nature and was not powered to detect a statistically significant treatment effect; therefore, results should be interpreted with caution.

Learn more about ZEJULA

Efficacy

See ZEJULA efficacy in PRIMA

QoL

See how ZEJULA impacted QoL in PRIMA

Safety

See ZEJULA safety in PRIMA

ZEJULA is indicated:1

  • 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.

Footnotes

AE, adverse event; AST, aspartate aminotransferase; BRCA, breast cancer susceptibility gene; BRCAmut, BRCA mutation; CI, confidence interval; HR, hazard ratio; HRd,homologous recombination deficient; MoA, mechanism of action; PFS, progression free survival; QoL, quality of life; TB, total bilirubin; ULN, upper limit of normal.

References

  1. ZEJULA Summary of Product Characteristics.
  2. Korach J, Graybill W, Redondo A, et al. Niraparib in patients with newly diagnosed advanced ovarian BRCAm cancer: a post hoc analysis of the PRIMA/ENGOT-OV26/GOG-3012 trial. Abstract presented at the European Society of Gynaecological Oncology (ESGO) Congress; 14-16 December 2020. Abstract 571.
  3. GSK, Inc. Data on file. 2020 [Niraparib Global Data Sheet].
  4. González-Martín A, Pothuri B, Vergote I, et al. Niraparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2019;381(25):2391-2402.
  5. Monk BJ, Han S, Pothuri B, et al. Efficacy of Niraparib Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer by BRCA and Homologous Recombination Status: PRIMA/ENGOT-OV26/ GOG-3012 Study. Poster presented at the Society of Gynecologic Oncology (SGO) 2020 Webinar Series.

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

Zejula is a registered trademark of the GlaxoSmithKline group of companies.

September 2024 PM-IE-NRP-WCNT-220019