Renagel

sevelamer

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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 Renagel?

Renagel is a medicine that contains the active substance sevelamer hydrochloride. It is available as tablets (400 and 800 mg).

What is Renagel used for?

Renagel is used to control hyperphosphataemia (high blood phosphate levels) in adults on dialysis (a blood clearance technique used in patients with kidney disease). It can be used in patients undergoing haemodialysis (dialysis using a blood filtration machine) or peritoneal dialysis (where fluid is pumped into the abdomen and an internal body membrane filters the blood). Renagel should be used with other treatments such as calcium or vitamin-D supplements to control the development of bone disease.

The medicine can only be obtained with a prescription.

How is Renagel used?

The recommended starting dose of Renagel depends on the level of phosphate in the blood and ranges from 800 to 1,600 mg three times a day. The dose of Renagel should be adjusted to ensure that the blood phosphate level stays below 1.76 mmol/l. Patients should take Renagel tablets whole with meals and stick to their prescribed diets.

How does Renagel work?

Patients with long-term kidney disease cannot eliminate phosphate from their bodies. This leads to hyperphosphataemia, which, in the long term, can cause complications such as heart and bone disease. The active substance in Renagel, sevelamer hydrochloride, is a phosphate binder. When taken with meals, it attaches 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.

How has Renagel been studied?

In haemodialysis, Renagel has been studied in two short-term studies lasting eight weeks and one longer study lasting 44 weeks. The first study compared Renagel with calcium acetate (another phosphate-lowering medicine) in 84 patients. The second, which did not compare Renagel with any other medicines, included 172 patients. The longer study looked at the use of Renagel in 192 patients, the majority of whom had taken Renagel in previous studies.

In peritoneal dialysis, there has been one study comparing Renagel with calcium acetate in 143 patients over 12 weeks.

In all of the studies, the main measure of effectiveness was the change in blood phosphate levels between the start and the end of treatment.

What benefit has Renagel shown during the studies?

Renagel produced a significant decrease in serum phosphate in all of the studies.

In the comparative study of patients undergoing haemodialysis, there was an average fall of 0.65 mmol/l over the eight weeks of Renagel treatment, compared with 0.68 mmol/l when the patients were taking calcium acetate. Patients taking Renagel had a similar fall in phosphate levels in the second study. In the third, there was an average fall of 0.71 mmol/l over 44 weeks.

In the study of patients undergoing peritoneal dialysis, the patients receiving Renagel had similar falls in phosphate as the patients receiving calcium acetate (0.52 and 0.58 mmol/l, respectively).

What is the risk associated with Renagel?

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

Renagel must not be used in people with hypophosphataemia (low blood phosphate levels) or with bowel obstruction (a blockage in the gut).

Why has Renagel been approved?

The CHMP decided that Renagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

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

A risk management plan has been developed to ensure that Renagel is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Renagel, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Renagel

The European Commission granted a marketing authorisation valid throughout the European Union for Renagel on 28 January 2000.

The full EPAR for Renagel can be found on the Agency’s website.

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

Name Language First published Last updated
Renagel : EPAR - Summary for the public BG = bălgarski 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public ES = español 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public CS = čeština 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public DA = dansk 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public DE = Deutsch 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public ET = eesti keel 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public EL = elliniká 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public EN = English 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public FR = français 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public IT = italiano 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public LV = latviešu valoda 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public LT = lietuvių kalba 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public HU = magyar 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public MT = Malti 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public NL = Nederlands 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public PL = polski 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public PT = português 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public RO = română 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public SK = slovenčina 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public SL = slovenščina 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public FI = suomi 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public SV = svenska 2008-07-21 2015-07-13
Renagel : EPAR - Summary for the public HR = Hrvatski 2008-07-21 2015-07-13

This EPAR was last updated on 09/02/2018 .

Authorisation details

Product details

Product details for Renagel
NameRenagel
Agency product numberEMEA/H/C/000254
Active substance

sevelamer

International non-proprietary name (INN) or common name

sevelamer

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

Publication details

Publication details for Renagel
Marketing-authorisation holder

Genzyme Europe B.V.

Revision29
Date of issue of marketing authorisation valid throughout the European Union28/01/2000

Contact address:

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

Product information

Product information

15/12/2017  Renagel -EMEA/H/C/000254 -N/0108

Name Language First published Last updated
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09
Renagel : EPAR - Product Information HR = Hrvatski 2009-09-04 2018-02-09

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
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  
Renagel : EPAR - All Authorised presentations HR = Hrvatski 2008-09-04  

Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

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

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

Assessment History

Authorised

This medicine is approved for use in the European Union