Doc. Ref.: EMEA/205861/2009 EMEA/H/C/993

RENVELA sevelamer carbonate

EPAR summary for the public

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.

7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea.europa.eu http://www.emea.europa.eu © European Medicines Agency, 2009. Reproduction is authorised provided the source is acknowledged.

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.

The full EPAR for Renvela can be found here.

This summary was last updated in 04-2009.

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