What is Renagel?
Renagel is a medicine containing the active substance sevelamer, available as white, oval-shaped tablets (400 mg and 800 mg).
What is Renagel used for?
Renagel is indicated for the control of hyperphosphataemia (increased rate of phosphate in the blood) in adult patients undergoing dialysis (a blood clearance technique). It can be used in patients undergoing hemodialysis (using a blood filtering machine) or peritoneal dialysis (the fluid is pumped into the abdomen and an internal membrane filters the blood). Renagel should be used with other treatments such as calcium supplements and vitamin D3 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 phosphates in the blood and ranges from 800 to 1, 600 mg three times a week. The dosage of Renagel should be adjusted to ensure that blood phosphate levels remain below 1.76 mmol / l. Patients should take whole Renagel tablets with meals and observe the prescribed diet. The safety and efficacy of Renagel in children have not been studied.
How does Renagel work?
Patients with severe kidney problems are not able to eliminate phosphates from their body, with the consequent appearance of hyperphosphatemia, a disease that, in the long term, can cause complications such as heart disease. The active substance in Renagel, sevelamer, is a substance capable of binding phosphates. Taken at meals, sevelamer binds to the phosphates present in food at the intestinal level, preventing them from being absorbed by the body and thus favoring the reduction of phosphate levels in the blood.
How has Renagel been studied?
The effects of Renagel were first tested in experimental models before being studied in humans.
Regarding hemodialysis, Renagel has been studied in two short-term studies, lasting 8 weeks, and in a long-term study lasting 44 weeks. In the first study Renagel was compared to calcium acetate (another drug that reduces the phosphate level) in 84 patients. The second study, in which Renagel was not compared with other drugs, was conducted on 172 patients. The longer study examined the use of Renagel in 192 patients, most of whom had already taken the drug in previous studies.
Regarding peritoneal dialysis, a 12-week study was conducted in which the efficacy of Renagel was compared with that of calcium acetate in 143 patients.
In all studies, the main measure of effectiveness was the change in blood phosphate levels, measured at the beginning and end of treatment.
What benefit has Renagel shown during the studies?
Renagel significantly reduced serum phosphate levels in all studies.
In the comparative study conducted on patients undergoing hemodialysis, there was an average reduction of 0.65 mmol / l during the eight weeks of treatment with Renagel compared to the average of 0.68 mmol / l recorded by patients taking calcium acetate. In the second study, patients treated with Renagel reported similar reductions in phosphate levels. In the third study, an average reduction of 0.71 mmol / l was observed in 44 weeks.
In the study carried out on patients undergoing peritoneal dialysis, patients treated with Renagel recorded reductions in the phosphate rate similar to those found with the administration of 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, 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 other substances in the medicine. Furthermore, Renagel must not be used in people with hypophosphataemia (decreased phosphate levels in the blood) or intestinal obstruction (obstruction).
Why has Renagel been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Renagel's benefits are greater than its risks for the control of hyperphosphataemia in adult patients undergoing hemodialysis or peritoneal dialysis. The Committee therefore recommended that Renagel be given marketing authorization.
Renagel was initially authorized in "exceptional circumstances" because limited information was available for scientific reasons at the time the authorization was granted. Since the company provided the additional information requested, the condition referring to "exceptional circumstances" was removed on June 26, 2006.
More information on Renagel:
On 28 January 2000, the European Commission issued a marketing authorization for Renagel, valid throughout the European Union, to Genzyme Europe BV. The marketing authorization was renewed on 28 January 2005.
The full EPAR for Renagel can be found here.
Last update of this summary: 06-2008
