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Life on her terms with individualised once-daily oral dosing¹

The recommended starting dose of ZEJULA is 300 mg once-daily¹

  • Individualised dosing that enables long-term treatment¹

    Easy dose adjustment with 100 mg capsules to manage non-haematologic side effects¹

    A once-daily oral treatment that can be taken any time of the day, with or without food.¹
    gsk-dosing-dose-adjustments

gsk-dosing-dose-adjustments

    In the NOVA study:

    • 200 mg/day was the most commonly administered dose after modification²
    • Most AEs were resolved with dose adjustment within the first 3 months³

    Two baseline predictive factors help individualise dosing: body weight and platelet count.*²

    A starting dose of 200 mg/day may be considered for patients with a body weight <58 kg.†¹

    No dose adjustment needed in patients with mild to moderate renal or hepatic impairment; use with caution in patients with severe impairment.¹

    *Testing complete blood counts weekly for the first month, followed by monthly monitoring for the next 10 months of treatment and periodically after this time is recommended to monitor for clinically significant changes in any haematologic parameter during treatment.¹ †Approximately 25% of patients in the NOVA study weighed less than 58 kg.¹

  • Individualised dosing that does not compromise on efficacy² ⁴

    Estimated PFS by dose level measured after cycle 3 for all patients⁴

    gsk-dosing-lord-1

gsk-dosing-lord-1

    Figure adapted from Lord et al. 2018.⁴

    In the NOVA study:

    • Dose reductions were required for patients with specific haematologic and non-haematologic AEs⁴
    • PFS after cycle 3 was comparable for patients receiving 100 mg, 200 mg and 300 mg doses of ZEJULA² ⁴
  • ZEJULA offers low potential for drug-drug interactions and a long half-life¹

    ZEJULA has a low potential for drug-drug interactions¹

    gsk-dosing-ddi-table

gsk-dosing-ddi-table

    *Caution is recommended when ZEJULA is combined with active substances the metabolism of which is CYP3A4-dependent or CYP1A2-dependent and, notably, those having a narrow therapeutic range.¹

    Once-daily dosing with ZEJULA is enabled by a long half-life¹

    The metabolism of ZEJULA translates into a low potential for drug-drug interactions.¹

    gsk-dosing-half-life

gsk-dosing-half-life

AEs, adverse events; CEs, carboxylesterases; CI, confidence interval; CYP2D6, cytochrome P450 2D6; CYP3A4, cytochrome P450 3A4; HR, hazard ratio; P-gp, permeability glycoprotein; PFS, progression-free survival.

References

  1. ZEJULA (niraparib). Summary of Product Characteristics. 2020.
  2. Berek JS, Matulonis UA, Peen U, et al. Ann Oncol. 2018;29(8).
  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. Lord L, Mirza MR, Woelber L, et al. Safety and dose modification for patients with low body weight receiving niraparib in the ENGOT-OV16/NOVA phase 3 trial. Abstract presented at the Society of Gynaecologic Oncology (SGO) 2018; New Orleans, LA, USA, 24–27 March 2018. Abstract 20.
  5. Olaparib. Summary of Product Characteristics. 2019.
  6. Rucaparib. Summary of Product Characteristics. 2019.

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