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This site is intended only for Healthcare Professionals who are experienced in the management of anaemia associated with chronic kidney disease.

NEPH_2022_0049_UK | June 2022

Information for members of the public

EVRENZOTM▼ (roxadustat) is a medicine used in adults to treat the symptoms of anaemia (low red blood cell counts) caused by chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly).

 

If you have any questions about your health or treatment, please consult your doctor.

 

Further information on Evrenzo is available via the following links:

Evrenzo Summary of Product Characteristics

Patient Information Leaflet

UK Public Assessment Report

European Public Assessment Report

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk
By reporting side effects, you can help provide more information on the safety of this medicine.

 

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See https://yellowcard.mhra.gov.uk for how to report side effects.

NEPH_2022_0049_UK | June 2022

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Introducing EVRENZO

  • The HIF pathway

    The HIF (hypoxia-inducible factor) pathway plays a central role in erythropoiesis.1,2

    It is the physiological mechanism by which the body responds to low oxygen conditions, such as those experienced at high altitude.2

    Activation of the HIF pathway affects all the key components of eythropoiesis:1
    • Increases erythropoietin (EPO) production
    • Suppresses hepcidin production
    • Improves iron availability by increasing iron absorption and transportation and release from storage

    The HIF pathway is critically important to oxygen sensing3

    In normoxic conditions, the HIF pathway is not activated and the HIF-α subunit is rapidly degraded via HIF prolyl-hydroxylase (HIF-PH):3

    Illustration of HIF pathway - normal oxygen

    In hypoxic conditions, the HIF pathway is activated: the HIF-α subunit is not degraded, allowing dimerisation with the HIF-ß subunit and so inducing the transcription and translation of target hypoxia response genes involved in erythropoiesis, including:3-6

    HIF pathway image

    In CKD, oxygen sensing via HIF is impaired, and this contributes to the development of anaemia.7

    Inhibiting the breakdown of HIF offers the opportunity to override the effect of CKD on oxygen sensing as well as stimulating the production of erythropoetic genes and their associated proteins.1

    CKD, chronic kidney disease; HIF, hypoxia-inducible factor; HIF-PH, hypoxia-inducible factor prolyl-hydroxylase; EPO, erythropoietin.

    MAT-UKE-EVZ-2023-00006 / January 2024 

    References

    • Locatelli F et al. Am J Nephrol. 2017;45:187-199.
    • Koury MJ, Haase VH. Nat Rev Nephrol. 2015;11:394–410.
    • Haase VH. Hemodial Int. 2017;21:S110–S124.
    • Biggar P, Gheun-Ho K. Kidney Res Clin Pract. 2017;36:209–223.
    • Del Vecchio L, Locatelli F. Expert Opin Investig Drugs. 2018;27:613–621.
    • EVRENZO SmPC.
    • Guedes M et al. Kidney360. 2020;(1):855-62.

  • EVRENZO: a first-in-class treatment1

    EVRENZO is a HIF-PH inhibitor

    EVRENZO mimics the body’s natural response to hypoxia by activating the HIF pathway2,3

    Illustration of Evrenzo - mimicking hypoxia


    EVRENZO inhibits HIF-PH, thus preventing breakdown of HIF-α and activating the HIF pathway2,3


    This induces transcription and translation of genes involved in erythropoiesis2,3

    HIF-PH inhibitors induce activation of the genes responsible for erythropoiesis, but do so in the presence of normal oxygen tension.4

    EVRENZO reduces hepcidin levels and improves iron availability3

    Through the inhibition of HIF-PH, EVRENZO stimulates a coordinated erythropoietic response that not only increases erythropoietin (EPO) levels, but also increases iron availability as well as helping to overcome the effects of inflammation by suppressing hepcidin.3

    Illustration of effect of Evrenzo on hepcidin and iron

    Adapted from Haase, 2017.5

    See how EVRENZO works

    EVRENZO Mechanism of action

    EVRENZO is indicated for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD)3

    CKD, chronic kidney disease; EPO, erythropoietin; HIF, hypoxia-inducible factor; HIF-PH, hypoxia-inducible factor prolyl-hydroxylase.

    MAT-UKE-EVZ-2023-00006 / January 2024

    References

    • Sanghani NS, Haase VH. Adv Chronic Kidney Dis. 2019;26(4):253-266.
    • Del Vecchio L, LocateIIi F. Expert Opin Investig Drugs. 2018;27(1):125-133.
    • EVRENZO SmPC.
    • Locatelli F et al. Am J Nephrol. 2017;45:187-199.
    • Haase VH. Hemodial Int. 2017;21:S110–S124.

  • EVRENZO promotes a coordinated erythropoietic response1-3

    By inhibiting HIF-PH, EVRENZO stimulates a coordinated erythropoietic response that:1,2

    Diagram of effects of Evrenzo

    Hb, haemoglobin; HIF-PH, hypoxia-inducible factor prolyl-hydroxylase; RBC, red blood cell.

    MAT-UKE-EVZ-2023-00006 / January 2024

    References

    • EVRENZO SmPC.
    • Del Vecchio L, LocateIIi F. Expert Opin Investig Drugs. 2018;27(1):125-133.
    • Locatelli F et al. Am J Nephrol. 2017;45:187-199.

  • The place of EVRENZO in management of anaemia of CKD

    EVRENZO has the potential to change the clinical management of anaemia of CKD.1

    Instead of treating the conditon as a deficiency of EPO or iron, EVRENZO addresses multiple factors that contribute to anaemia.1

    Targeting the HIF pathway with HIF-PHIs may offer an advance in clinical practice by providing a more comprehensive and physiological approach to the management of anaemia of CKD.

    EVRENZO addresses the pathophysiology of anaemia of CKD in a physiologically coordinated way, activating the HIF pathway to deliver:

    • Sustained haemoglobin control without routine dose escalation, irrespective of inflammation2,3,4
    • Improved iron regulation and reduced use of IV iron compared with exo EPO3,5-7

    EVRENZO (roxadustat) is indicated for treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD)6

    CKD, chronic kidney disease; EPO, erythropoietin; ESA, HIF, hypoxia-inducible factor; HIF-PHI, hypoxia-inducible factor prolyl-hydroxylase inhibitor; IV, intravenous;

    MAT-UKE-EVZ-2023-00006 / January 2024 

    References

    • Del Vecchio l, Locatelli F. Expert Opin Investig Drugs. 2018; 27(7):613-621
    • Locatelli F et al. Am J Nephrol. 2017; 45:187-199
    • Barratt J et al. Nephrol Dial Transplant. 2021; 36(9):1616-28
    • Pollock C et al. Kidney International Reports.2021;6(4):S108
    • Li Z et al. Kidney Dis. (Basel). 2020; 6(2):65-73
    • EVRENZO SmPC
    • Fishbane S et al. JASN 2022;33:850–66

  • EVRENZO- from the start and for the future

    EVRENZO addresses the pathophysiology of anaemia of CKD in a physiologically coordinated way1,  activating the HIF pathway to deliver:

    • sustained haemoglobin control without routine dose escalation2-5 , irrespective of baseline inflammation4,6
    • improved iron regulation and reduced use of IV iron compared with exo EPO2-4,7
    Examine the evidence
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    Listen to expert opinion

    AE, adverse event; CKD, chronic kidney disease; Hb, haemoglobin; ESA, erythropoiesis-stimulating agent; MoA, mechanism of action; IV, intravenous; SmPC, Summary of Product Characteristics

    MAT-UKE-EVZ-2023-00006 / January 2024 

    References

    • Li Z et al. Kidney Dis. (Basel). 2020; 6(2):65-73
    • EVRENZO SmPC
    • Barratt J et al. Nephrol Dial Transplant. 2021; 36(9):1616-28
    • Barratt J et al. Adv Ther. 2021;38:5345–5360 (Supplement)
    • Astellas Data on File. Dosing used for EVRENZO-treated patients in the NDD pool, 2021.[EVZ_2021_0029_ABC].
    • Astellas Data on File. Dosing used for EVRENZO- and ESA-treated patients in the stable dialysis pool (grouped by CRP range). 2021.
    • Astellas Data on File. Iron usage in the overall DD pool, 2021. [EVZ_2021_0028_ABC].