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A safety profile that lets her stay on ZEJULA long term¹⁻³

  • A well-characterised safety and tolerability profile¹ ²

    Most common AEs in ≥10% of patients treated with ZEJULA*¹

    gsk-safety-common-aes gsk-safety-common-aes

    *Frequencies above 1% were rounded to whole numbers. Data are presented for all patients in the safety population (n=546).¹ †Includes reports of thrombocytopenia and decreased platelet count. ‡Includes reports of fatigue, asthenia, malaise and lethargy. §Includes reports of anaemia and decreased haemoglobin count. ¶Includes reports of neutropenia, decreased neutrophil count and febrile neutropenia.

    • The most common serious AEs were thrombocytopenia and anaemia²
    • ZEJULA is a treatment she can stick with: only 14.7% of patients discontinued treatment with ZEJULA vs 2.2% with Placebo¹

  • A manageable safety profile that enables long-term treatment³

    Non-haematologic AEs by duration of exposure to ZEJULA³

    gsk-safety-non-haem-aes-zejula gsk-safety-non-haem-aes-zejula

    Non-haematologic AEs by duration of exposure to Placebo³

    gsk-safety-non-haem-aes-placebo gsk-safety-non-haem-aes-placebo

    Of the initial 367 patients in the ZEJULA treatment group and 179 in the placebo treatment group, 18.8% and 5.6% of patients were included in the 2 to 4 year evaluation period, respectively.³

    Most AEs were resolved with dose adjustment within the first 3 months, leading to a low incidence over 4 years.³

  • Low rate of haematologic AEs over 4 years³

    Grade ≥3 haematologic AEs by duration of exposure to ZEJULA³

    gsk-safety-haem-aes-zejula gsk-safety-haem-aes-zejula

    Grade ≥3 haematologic AEs by duration of exposure to Placebo³

    gsk-safety-haem-aes-placebo gsk-safety-haem-aes-placebo

    Of the initial 367 patients in the ZEJULA treatment group and 179 in the placebo treatment group, 18.8% and 5.6% of patients were included in the 2 to 4 year evaluation period, respectively.³

    Most AEs were resolved with dose adjustment within the first 3 months, leading to a low incidence over 4 years.³

  • Preserves quality of life throughout treatment⁴

    FOSI in gBRCAmut patients (n=203)⁴

    gsk-safety-mirza gsk-safety-mirza

    Figure adapted from Supplementary Appendix to: Mirza et al. 2016.⁴

    FOSI in non-gBRCAmut patients (n=350)⁴

    gsk-safety-mirza-2 gsk-safety-mirza-2

    Figure adapted from Supplementary Appendix to: Mirza et al. 2016.⁴

    Patients on ZEJULA maintained a quality of life comparable to placebo throughout treatment.⁴

  • Learn more about FOSI

    FOSI: a validated, 8-item measure of symptom response to treatment⁴,⁵

    gsk-safety-fosi gsk-safety-fosi

    Patients respond to their symptom experience over the past 7 days using a 5-point Likert scale from 'not at all' (0) to 'very much' (4).

AE, adverse event; BRCA, breast cancer susceptibility gene; C, cycle; gBRCAmut, germline BRCA mutation; FOSI, Functional Assessment of Cancer Therapy-Ovarian Symptom Index; Post-Prog, post-progression; SE, standard error.

References

  1. Mirza MR, Monk BJ, Herrstedt J, et al. N Engl J Med. 2016;375(22).
  2. ZEJULA (niraparib). Summary of Product Characteristics. 2020.
  3. Juden LM, Freese E, Bessette P, et al. Long-term safety of niraparib in patients with recurrent ovarian cancer: results from the ENGOT-OV16/NOVA trial. Poster presented at Oncology Nursing Society 44th Annual Congress; Anaheim, CA, USA, 11–14 April 2019.
  4. Supplementary Appendix to: Mirza MR, Monk BJ, Herrstedt J, et al. N Engl J Med. 2016;375(22).
  5. GSK, Inc. Data on file. 2018.

ZEJULA je registrovaný léčívý přípravek, jehož výdej je vázán na lékařský předpis a není dosud hrazen z prostředků veřejného zdravotního pojištění. O mimořádnou úhradu si lze zažádat dle § 16 zákona č. 48/1997 Sb., o veřejném zdravotním pojištění.Léčivý přípravek podléhá dalšímu sledování. Případná podezření na nežádoucí účinky nám prosím hlaste na cz.safety@gsk.com. Před předepsáním léku se, prosím, seznamte s úplnou informací o přípravku, kterou najdete v Souhrnu údajů o přípravku na www.gskkompendium.cz nebo se obraťte na společnost GlaxoSmithKline, s.r.o., Hvězdova 1734/2c, 140 00 Praha 4; e-mail: cz.info@gsk.com; www.gsk.cz.

© 2020 GSK Group of Companies or its licensor.
Trademarks are the property of their respective owners.

Schváleno 11/2020. PM-CZ-NRP-WCNT-200002