Vafseo | European Medicines Agency (EMA)

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Overview

Vafseo is a medicine used to treat the symptoms of anaemia (low red blood cell counts) caused by chronic kidney disease (long-term, progressive decrease in the ability of the kidneys to work properly) in adult patients on dialysis (a technique for removing unwanted substances and excess fluid from the blood when the kidneys do not work well enough).

Vafseo contains the active substance vadadustat.

Vafseo can only be obtained with a prescription, and treatment should be started by a doctor experienced in the management of anaemia. It is available as tablets to be taken once a day.

For more information about using Vafseo, see the package leaflet or contact your doctor or pharmacist.

Patients with chronic kidney disease may not produce enough erythropoietin, a hormone needed to stimulate the production of red blood cells. The active substance in Vafseo, vadadustat, acts on an enzyme called hypoxia-inducible factor prolyl hydroxylase (HIF-PH). This stimulates the natural response that normally occurs when oxygen levels are low, including the production of erythropoietin and red blood cells.

Two main studies involving nearly 4,000 patients with anaemia caused by chronic kidney disease who were on dialysis showed that Vafseo was as effective as darbepoetin alfa (another medicine for treating anaemia) at increasing blood levels of haemoglobin.

For the full list of side effects and restrictions with Vafseo, see the package leaflet.

The most common side effects with Vafseo (which may affect more than 1 in 10 people) include thromboembolic events (problems due to the formation of blood clots in the blood vessels), diarrhoea and hypertension (high blood pressure).

Vafseo was shown to be as effective as the comparator medicine darbepoetin alfa at treating anaemia in patients with chronic kidney disease who were on dialysis. With regard to safety, the risk of thromboembolic events in patients treated with Vafseo is addressed with warnings in the prescribing information. The European Medicines Agency therefore decided that Vafseo’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vafseo have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Vafseo are continuously monitored. Suspected side effects reported with Vafseo are carefully evaluated and any necessary action taken to protect patients.

Vafseo received a marketing authorisation valid throughout the EU on 24 April 2023.

Further information on Vafseo can be found on the Agency’s website: ema.europa.eu/medicines/human/EPAR/vafseo

This overview was last updated in 04-2023.

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First published: 31/05/2023

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Product information

English (EN)
(550.32 KB – PDF)

First published: 31/05/2023Last updated: 27/03/2025

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Latest procedure affecting product information:
N/0000254042

27/03/2025

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

Product information documents contain:

summary of product characteristics (annex I);
manufacturing authorisation holder responsible for batch release (annex IIA);
conditions of the marketing authorisation (annex IIB);
labelling (annex IIIA);
package leaflet (annex IIIB).

English (EN)
(61.62 KB – PDF)

First published: 31/05/2023

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Product details

Name of medicine

Vafseo

Active substance

Vadadustat

International non-proprietary name (INN) or common name

vadadustat

Therapeutic area (MeSH)

Renal Insufficiency, Chronic
Anemia

Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

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Vafseo | European Medicines Agency (EMA)

Overview

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Therapeutic indication

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Vafseo | European Medicines Agency (EMA)

Overview

How is Vafseo used?

How does Vafseo work?

What benefits of Vafseo have been shown in studies?

What are the risks associated with Vafseo?

Why is Vafseo authorised in the EU?

What measures are being taken to ensure the safe and effective use of Vafseo?

Other information about Vafseo

Product information

Product details

Pharmacotherapeutic group

Therapeutic indication

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