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ZEJULA has a well-characterised safety profile1,2

  • The safety and tolerability profile is well-characterised and consistent with previous clinical trial experience¹,²

    AEs reported in ≥10% of all patients in PRIMA1

    Most common adverse events reported graph Most common adverse events reported graph

    In the overall population, 12% of patients discontinued treatment with ZEJULA due to adverse events1,2

    • Discontinuation of ZEJULA in >1% of patients included thrombocytopenia (3.7%), anaemia (1.9%), nausea and neutropenia (1.2% each)1

  • Side effects can be managed with dose interruption and modification¹,²

    Side effects can be managed with dose interruption and modification1,2

    • AEs led to dose interruptions and reduction in 80% of patients, most frequently from thrombocytopenia (56%), anaemia (33%), and neutropenia (20%)1
    • No specific drug-drug interactions have been reported with ZEJULA*1

    Monitoring complete blood counts, blood pressure and heart rate will help identify the need to dose modify†1

    Blood counts icon Heart rate icon Blood counts icon Heart rate icon

    A lower starting dose may be considered based on baseline weight (<77 kg) and platelet count (<150,000/μL).1 Find out more

    *No clinical drug interaction studies have been performed with ZEJULA.
    †Monitor periodically. Schedule provided as an example.

  • Lower rates of haematologic adverse reactions were observed with an individualised starting dose, while maintaining improvement in PFS¹

    Rates of select Grades 3–4 haematological adverse reactions1

    Grade 3-4 haematological adverse reactions graph Grade 3-4 haematological adverse reactions graph

    PRIMA prospectively evaluated the safety and efficacy of an individualised starting dose of either 200 mg or 300 mg, selected based on baseline weight and platelet count, as well as a fixed starting dose of 300 mg. In PRIMA, patients in the overall and individualised populations experienced the same rates of Grades 3–4 leukopenia.1

    The individualised starting dose was efficacious and is the approved starting dose for ZEJULA in first-line maintenance1

    • HR 0.68 (95% CI: 0.48–0.97) in the overall population (n=258)
    • HR 0.39 (95% CI: 0.22–0.72) in the HRd population (n=130)

    This analysis is exploratory in nature; it does not control for type 1 error and is not powered to determine treatment effect in any subgroup.1

  • Health-related quality of life was maintained throughout the duration of treatment²,³

    FOSI in the overall population3

    FOSI in overall population graph FOSI in overall population graph

    This analysis is exploratory in nature and does not control for type 1 error; elements more distal to disease and treatment-related symptoms may be influenced by multiple nondrug factors.3 FOSI is a validated 8-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.3 Values displayed in the chart above are adjusted means; a higher score indicates fewer symptoms.

    Patients on ZEJULA maintained a quality of life comparable to placebo throughout treatment.2,3

AE, adverse event; ALT, alanine transaminase; AST, aspartate transaminase; CI, confidence interval; FOSI, Functional Assessment of Cancer Therapy-Ovarian Symptoms Index; HR, hazard ratio; HRd, homologous recombination deficient; SE, standard error.

References

  1. ZEJULA (niraparib). Summary of Product Characteristics. 2020.
  2. González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. N Engl J Med. 2019;381(25):2391–2402.
  3. Supplementary Appendix to: González-Martín A, Pothuri B, Vergote I, et al; for the PRIMA/ENGOT-OV26/GOG-3012 Investigators. N Engl J Med. 2019;381(25):2391–2402.

ZEJULA je registrovaný léčivý 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 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.

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Schváleno 02/2021 PM-CZ-NRP-WCNT-200003