Renagel

sevelamer

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 white, oval 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 should not be used in people who may be hypersensitive (allergic) to sevelamer or any of the other ingredients. 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 Committee for Medicinal Products for Human Use (CHMP) decided that Renagel’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Renagel was originally authorised under ‘exceptional circumstances’, because, for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 26 June 2006.

Other information about Renagel

The European Commission granted a marketing authorisation valid throughout the European Union for Renagel to Genzyme Europe B.V. on 28 January 2000. After ten years, the marketing authorisation was renewed for a further five years.

This EPAR was last updated on 20/03/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

22/12/2011  Renagel -EMEA/H/C/000254 -WS/0188

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.

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.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents