Renvela

sevelamer carbonate

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This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Renvela?

Renvela is a medicine that contains the active substance sevelamer carbonate. It is available as white tablets (800 mg) and as a powder (1.6 g and 2.4 g) to be made up into an oral suspension.

What is Renvela used for?

Renvela is used to control hyperphosphataemia (high blood phosphate levels) in:

  • adult patients on dialysis (a blood clearance technique). It can be used in patients undergoing haemodialysis (using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood);
  • patients with chronic (long-term) kidney disease who are not on dialysis and have a serum (blood) phosphorus level equal to or above 1.78 mmol/l.

Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease.

The medicine can only be obtained with a prescription.

How is Renvela used?

The recommended starting dose of Renvela depends on clinical need and the level of phosphate in the blood and ranges from 2.4 to 4.8 grams per day. Renvela must be taken three times a day with meals and patients should keep to their prescribed diets.

The dose of Renvela should be adjusted every two to four weeks to reach an acceptable level of phosphate in the blood, which should then be monitored regularly. The tablets should be taken whole and the oral suspension should be taken within 30 minutes of being prepared.

How does Renvela work?

Patients with severe kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart disease. The active substance in Renvela, sevelamer carbonate, is a phosphate binder. When taken with meals, the sevelamer molecules in sevelamer carbonate bind to phosphate from food within the gut, preventing it from being absorbed into the body. This helps to reduce the phosphate levels in the blood.

Renvela is similar to another medicine, Renagel, which has been available in the European Union since 2000. Renagel contains sevelamer as the hydrochloride salt, and not the carbonate in Renvela.

How has Renvela been studied?

The effects of Renvela were first tested in experimental models before being studied in humans.

Two main studies compared Renvela with Renagel in 110 adults who were on dialysis. All patients had chronic kidney disease with hyperphosphataemia and had been on haemodialyis for at least three months. They had all previously taken oral phosphate binder treatment and most patients took vitamin D. The two studies were crossover studies: patients first received either Renvela (tablets or powder) or Renagel, and the treatments were then switched after four or eight weeks. The main measure of effectiveness was the average amount of phosphate in the blood during treatment.

A third main study involving 49 patients studied Renvela in patients with hyperphosphataemia with a serum phosphorus level equal to or above 1.78 mmol/l and who were not on dialysis. Patients received Renvela for eight weeks. The main measure of effectiveness was how much the blood phosphate was reduced at the end of treatment.

What benefit has Renvela shown during the studies?

Renvela was as effective as Renagel in reducing phosphate in patients with chronic kidney disease who were on dialysis. In two studies the average amount of phosphate in the blood during treatments with Renvela or Renagel was similar.

In the small study of patients not on dialysis who took Renvela, the average amount of phosphate in the blood was reduced by about a fifth, from 2.0 mmol/l to 1.6 mmol/l.

What is the risk associated with Renvela?

The most common side effects with Renvela (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, upper abdominal (tummy) pain and constipation. For the full list of all side effects reported with Renvela, see the package leaflet.

Renvela should not be used in people who may be hypersensitive (allergic) to sevelamer carbonate or any of the other ingredients. Renvela must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).

Why has Renvela been approved?

The Committee for Medicinal Products for Human Use (CHMP) noted that the study of Renvela in patients not on dialysis was too small to provide enough evidence on its own to support the medicine’s use in these patients. Despite this, the Committee concluded that the medicine can be used in patients not on dialysis because they had the same underlying disease as those on dialysis.

The CHMP therefore decided that Renvela’s benefits are greater than its risks for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis and in adult patients with chronic kidney disease who are not on dialysis and who have a serum phosphorus level equal to or above 1.78 mmol/l. The Committee recommended that Renvela be given marketing authorisation.

Which measures are being taken to ensure the safe use of Renvela?

The company that makes Renvela will make sure that educational materials are available in all Member States for patients and healthcare professionals. The programme will include information on the risk and prevention of peritonitis (inflammation of the lining of the abdomen) in patients undergoing peritoneal dialysis, arterio-venous fistula (an abnormal passageway between an artery and a vein) in patients undergoing haemodialysis, and vitamin deficiency in patients with chronic kidney disease.

Other information about Renvela

The European Commission granted a marketing authorisation valid throughout the European Union for Renvela to Genzyme Europe B.V. on 10 June 2009.

Name Language First published Last updated
Renvela : EPAR - Summary for the public BG = bălgarski 23/06/2009  
Renvela : EPAR - Summary for the public ES = español 23/06/2009  
Renvela : EPAR - Summary for the public CS = čeština 23/06/2009  
Renvela : EPAR - Summary for the public DA = dansk 23/06/2009  
Renvela : EPAR - Summary for the public DE = Deutsch 23/06/2009  
Renvela : EPAR - Summary for the public ET = eesti keel 23/06/2009  
Renvela : EPAR - Summary for the public EL = elliniká 23/06/2009  
Renvela : EPAR - Summary for the public EN = English 23/06/2009  
Renvela : EPAR - Summary for the public FR = français 23/06/2009  
Renvela : EPAR - Summary for the public IT = italiano 23/06/2009  
Renvela : EPAR - Summary for the public LV = latviešu valoda 23/06/2009  
Renvela : EPAR - Summary for the public LT = lietuvių kalba 23/06/2009  
Renvela : EPAR - Summary for the public HU = magyar 23/06/2009  
Renvela : EPAR - Summary for the public MT = Malti 23/06/2009  
Renvela : EPAR - Summary for the public NL = Nederlands 23/06/2009  
Renvela : EPAR - Summary for the public PL = polski 23/06/2009  
Renvela : EPAR - Summary for the public PT = português 23/06/2009  
Renvela : EPAR - Summary for the public RO = română 23/06/2009  
Renvela : EPAR - Summary for the public SK = slovenčina 23/06/2009  
Renvela : EPAR - Summary for the public SL = slovenščina 23/06/2009  
Renvela : EPAR - Summary for the public FI = suomi 23/06/2009  
Renvela : EPAR - Summary for the public SV = svenska 23/06/2009  

This EPAR was last updated on 30/08/2016 .

Authorisation details

Product details

Product details for Renvela
NameRenvela
Agency product numberEMEA/H/C/000993
Active substance

sevelamer carbonate

International non-proprietary name (INN) or common name

sevelamer carbonate

Therapeutic area HyperphosphatemiaRenal Dialysis
Anatomical therapeutic chemical (ATC) code V03AE02

Publication details

Publication details for Renvela
Marketing-authorisation holder

Genzyme Europe B.V.

Revision11
Date of issue of marketing authorisation valid throughout the European Union10/06/2009

Contact address:

Genzyme Europe B.V.
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

Product information

25/08/2016  Renvela -EMEA/H/C/000993 -PSUSA/2697/201510

Name Language First published Last updated
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016
Renvela : EPAR - Product Information SV = svenska 13/08/2009 30/08/2016

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
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  
Renvela : EPAR - All Authorised presentations SV = svenska 23/06/2009  

Name Language First published Last updated
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV SV = svenska 23/06/2009  

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.

Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.

Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Renvela : EPAR - Public assessment report SV = svenska 23/06/2009  
Committee for medicinal products for human use, summary of positive opinion for Renvela SV = svenska 19/03/2009  

Authorised

This medicine is approved for use in the European Union