Veltassa

patiromer

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This is a summary of the European public assessment report (EPAR) for Veltassa. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Veltassa.

For practical information about using Veltassa, patients should read the package leaflet or contact their doctor or pharmacist.

What is Veltassa and what is it used for?

Veltassa is a medicine used for treating adults with high levels of potassium in the blood (hyperkalaemia). Hyperkalaemia can cause serious heart problems and muscle weakness.

Veltassa contains the active substance patiromer.

How is Veltassa used?

Veltassa is available as sachets (8.4, 16.8 and 25.2 g) of patiromer containing a powder for mixing with water or some fruit juices and taking by mouth. The recommended starting dose is 8.4 g once a day. The doctor then adjusts the dose at intervals of at least one week, based on the patient’s blood levels of potassium. The maximum dose is 25.2 g once a day. The Veltassa mixture should be taken with food and at least 3 hours before or after any other medicines the patient takes by mouth. For further information, see the package leaflet.

The medicine can only be obtained with a prescription.

How does Veltassa work?

When Veltassa is taken by mouth, the active substance, patiromer, remains in the gut where it attaches tightly to potassium to form a compound that is then passed out in the stool. In this way patiromer draws potassium from the body into the gut and so reduces the amount of potassium in the blood.

What benefits of Veltassa have been shown in studies?

One main study involving patients with chronic kidney disease who had hyperkalaemia found that Veltassa is effective in reducing potassium levels in the blood.

In the first part of the study, 243 patients with hyperkalaemia (with average potassium level of 5.6 mmol/litre) were treated with Veltassa. After 4 weeks of treatment, their potassium level fell on average by 1.0 mmol/litre.

The second part of the study compared Veltassa with placebo (a dummy treatment) in 107 patients whose potassium level had fallen with Veltassa treatment during the first part of the study. After 4 weeks, the average potassium level did not change in patients who received Veltassa for 4 weeks but it went back up by an average of 0.7 mmol/litre in patients who received placebo.

What are the risks associated with Veltassa?

The most common side effects with Veltassa (which may affect more than 1 in 100 people) are those affecting the digestive system (constipation, diarrhoea, abdominal pain and wind) and blood tests showing low levels of magnesium in the blood. For the full list ofall side effects and restrictions with Veltassa, see the package leaflet.

Why is Veltassa approved?

The European Medicines Agency decided that Veltassa’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that there is a need for effective treatment of hyperkalaemia and Veltassa achieves a meaningful lowering of potassium levels. The side effects are relatively moderate but the doctor should take them into account when considering treatment with Veltassa.

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

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

Other information about Veltassa

The European Commission granted a marketing authorisation valid throughout the European Union for Veltassa on 19 July 2017.

For more information about treatment with Veltassa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Veltassa : EPAR - Summary for the public BG = bălgarski 2017-08-01  
Veltassa : EPAR - Summary for the public ES = español 2017-08-01  
Veltassa : EPAR - Summary for the public CS = čeština 2017-08-01  
Veltassa : EPAR - Summary for the public DA = dansk 2017-08-01  
Veltassa : EPAR - Summary for the public DE = Deutsch 2017-08-01  
Veltassa : EPAR - Summary for the public ET = eesti keel 2017-08-01  
Veltassa : EPAR - Summary for the public EL = elliniká 2017-08-01  
Veltassa : EPAR - Summary for the public EN = English 2017-08-01  
Veltassa : EPAR - Summary for the public FR = français 2017-08-01  
Veltassa : EPAR - Summary for the public IT = italiano 2017-08-01  
Veltassa : EPAR - Summary for the public LV = latviešu valoda 2017-08-01  
Veltassa : EPAR - Summary for the public LT = lietuvių kalba 2017-08-01  
Veltassa : EPAR - Summary for the public HU = magyar 2017-08-01  
Veltassa : EPAR - Summary for the public MT = Malti 2017-08-01  
Veltassa : EPAR - Summary for the public NL = Nederlands 2017-08-01  
Veltassa : EPAR - Summary for the public PL = polski 2017-08-01  
Veltassa : EPAR - Summary for the public PT = português 2017-08-01  
Veltassa : EPAR - Summary for the public RO = română 2017-08-01  
Veltassa : EPAR - Summary for the public SK = slovenčina 2017-08-01  
Veltassa : EPAR - Summary for the public SL = slovenščina 2017-08-01  
Veltassa : EPAR - Summary for the public FI = suomi 2017-08-01  
Veltassa : EPAR - Summary for the public SV = svenska 2017-08-01  
Veltassa : EPAR - Summary for the public HR = Hrvatski 2017-08-01  

This EPAR was last updated on 01/08/2017 .

Authorisation details

Product details

Product details for Veltassa
NameVeltassa
Agency product numberEMEA/H/C/004180
Active substance

patiromer sorbitex calcium

International non-proprietary name (INN) or common name

patiromer

Therapeutic area Hyperkalemia
Anatomical therapeutic chemical (ATC) code V03AE09
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Publication details

Publication details for Veltassa
Marketing-authorisation holder

Vifor Fresenius Medical Care Renal Pharma France

Revision0
Date of issue of marketing authorisation valid throughout the European Union19/07/2017

Contact address:

Vifor Fresenius Medical Care Renal Pharma France
100-101 Terrasse Boieldieu
Tour Franklin La Defense 8
Paris La Defense
Cedex 92042 
Paris 
France

Product information

Product information

19/07/2017  Veltassa -EMEA/H/C/004180 --

Name Language First published Last updated
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  
Veltassa : EPAR - Product Information HR = Hrvatski 2017-08-01  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  
Veltassa : EPAR - All Authorised presentations HR = Hrvatski 2017-08-01  

Pharmacotherapeutic group

Drugs for treatment of hyperkalaemia and hyperphosphatemia

Therapeutic indication

Veltassa is indicated for the treatment of hyperkalaemia in adults

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Veltassa : EPAR - Public assessment report HR = Hrvatski 2017-08-01  
CHMP summary of positive opinion for Veltassa HR = Hrvatski 2017-05-19  

Authorised

This medicine is approved for use in the European Union