Evrenzo self attestation

Are you a Healthcare Professional?

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

Information for patients

The website you have tried to access contains clinical information designed specifically for medical professionals experienced in treating this condition. If you have any questions about your health or treatment, please consult your doctor.

 

Astellas
evrenzo leavingsoon

You are leaving the website

You are now leaving an Astellas Pharma Ltd. website.
Astellas bears no responsibility for the content of any 3rd party material
nor how it might be used. Click OK to proceed.

  • EVRENZO offers oral administration with a three times weekly tablet1

    How to user evrenzo1
    How to user evrenzo2

    Oral administration1

    • No need to administer in hospital1
    • Reduce the use of IV iron1
    • No special storage instructions – can be stored at ambient temperature1

    Taken three times weekly not on consecutive days1

    How to user evrenzo3

    Reduced use of IV iron compared to ESA1

    • EVRENZO treatment reduced the use of iron supplementation compared with treatment with ESA1

    IV, intravenous; TIW, three times weekly.

    References

    • EVRENZO SmPC.
  • EVRENZO offers a flexible starting dose regimen

    • All other causes of anaemia should be evaluated and adequate iron stores should be ensured prior to initating treatment with EVRENZO

    ESA-naive patients1

    Body weight Recommended
    starting dose for
    EVRENZO
    <100 kg 70 mg, 3x per week
    ≥100 kg 100 mg, 3x per week

    Patients converting from an ESA1

    • Conversion of dialysis patients otherwise stable on ESA treatment is only to be considered when there is a valid clinical reason

    • Conversion of non-dialysis patients otherwise stable on ESA treatment has not been investigated. A decision to treat these patients with EVRENZO should be based on a benefit-risk consideration for the individual patient

    • The recommended starting dose of EVRENZO is based on the average prescribed ESA dose in the 4 weeks before conversion
    • The first EVRENZO dose should replace the next scheduled dose of the current ESA
    • The dose of EVRENZO can be individualised based on the average ESA dose in 4 weeks before conversion
    • It is not recommended to combine administration of EVRENZO and ESAs as the combination has not been studied
    Darbepoetin-alfa IV or SC dose (micrograms/week) Epoetin IV or SC dose (IU/week) Methoxy polyethylene glycol-epoetin beta IV or SC dose (micrograms/monthly) EVRENZO starting dose (milligrams three times per week, not on consecutive days)
    Less than 25 Less than 5,000 Less than 80 70
    25 to less than 40 5,000 up to 8,000 80 up to and including 120 100
    40 up to and including 80 More than 8,000 up to and including 16,000 More than 120 up to and including 200 150
    More than 80 More than 16,000 More than 200 200

    Initial Hb monitoring requirements for EVRENZO are similar to current standard of care for CKD1-3

    • Hb levels should be monitored every 2 weeks until the desired Hb level of 10–12 g/dL (100-120 g/L) is achieved and stabilised, and every 4 weeks thereafter, or as clinically indicated1

    CKD, chronic kidney disease; ESA, erythropoiesis-stimulating agent; Hb, haemoglobin; IU, international units; IV, intravenous; SC, subcutaneous.

    Reference

    • EVRENZO SmPC.
    • Epoetin alfa Hexal SmPC.
    • Aranesp SmPC.
  • Starting patients on EVRENZO

    Which patients will you consider first?

    Patients not on dialysis?

    Image of smiling man painting chair

    Patients new to dialysis?

    Image of smiling woman

    How to start patients on EVRENZO:

    • In addition to the presence of symptoms of anaemia, other clinical criteria should be evaluated1

    • All other causes of anaemia should be evaluated and adequate iron stores should ensured prior to initating treatment with EVRENZO1

    • The appropriate dose of EVRENZO must be taken orally three times per week and not on consecutive days1

    • The dose should be individualised to achieve and maintain target Hb levels of 10-12 g/dL (100-120 g/L) 1

    • EVRENZO treatment should not be continued beyond 24 weeks of therapy if a clinically meaningful increase in Hb levels is not achieved. Alternative explanations for an inadequate response should be sought and treated before re-starting EVRENZO1

    ESA, erythropoiesis-stimulating agent; Hb, haemoglobin.

    Reference

    • EVRENZO SmPC.



EVRENZO™ (roxadustat), 20, 50, 70, 100 och 150 mg filmdragerade tabletter, B03XA05, Rx, F

▼Detta läkemedel är föremål för utökad övervakning. Detta kommer att göra det möjligt att snabbt identifiera ny säkerhetsinformation. Hälso- och sjukvårdspersonal uppmanas att rapportera varje misstänkt biverkning.

Indikationen är behandling av vuxna patienter med symtomatisk anemi associerad med kronisk njursjukdom (CKD). Kontraindikationer är överkänslighet mot den aktiva substansen, jordnötter, soja eller hjälpämne, användning under graviditetens 3e trimester samt amning. Varningar och försiktighet inkluderar risk för allvarliga kardiovaskulära och trombovaskulära händelser, krampanfall och allvarliga infektioner inklusive sepsis. Ska inte sättas in hos kvinnor som planerar att bli gravida eller under graviditet. Felanvändning kan leda till en överdrivet förhöjd hematokrit vilket kan leda till livshotande komplikationer i hjärt-kärlsystemet. 

Astellas Pharma AB, Box 21046, 200 21 Malmö. Produktresumé 2022-09.  

För ytterligare information och förpackningar se www.fass.se.