Renvela
Authorised
This medicine is authorised for use in the European Union
sevelamer carbonate
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Renvela is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:
- adult patients on dialysis (a technique to remove unwanted substances from the blood);
- adults and children from 6 years of age with chronic (long term) kidney disease.
Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease. It contains the active substance sevelamer carbonate.
Renvela is available as tablets (800 mg) and as powder (0.8 g, 1.6 g and 2.4 g) in a sachet to be taken 3 times a day with meals. The dose to take depends on the patient’s level of blood phosphate and, in case of children, their height and weight. Renvela must not be taken on an empty stomach and patients should keep to their prescribed diets. The medicine can only be obtained with a prescription. For more information about using Renvela, see the package leaflet or contact your doctor or pharmacist.
The active substance in Renvela, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.
Renvela has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.
In two main studies in 110 adults with kidney disease who were on dialysis, Renvela brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another authorised medicine Renagel.
In a third main study in 49 adults who were not on dialysis, Renvela reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Finally, a main study also showed that Renvela was effective at lowering phosphate levels in 100 children: children who took Renvela had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.
The most common side effects with Renvela (which may affect more than 1 in 10 people) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation. For the full list of side effects with Renvela, see the package leaflet.
Renvela must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut). For the full list of restrictions, see the package leaflet.
Studies show that Renvela is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable. The European Medicines Agency therefore concluded that Renvela’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Renvela have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Renvela are continuously monitored. Side effects reported with Renvela are carefully evaluated and any necessary action taken to protect patients.
Renvela received a marketing authorisation valid throughout the EU on 10 June 2009.
Product information
Latest procedure affecting product information:
T/0066
19/12/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Renvela
- Active substance
- sevelamer carbonate
- International non-proprietary name (INN) or common name
- sevelamer carbonate
- Therapeutic area (MeSH)
- Hyperphosphatemia
- Renal Dialysis
- Anatomical therapeutic chemical (ATC) code
- V03AE02
Pharmacotherapeutic group
All other therapeutic productsTherapeutic 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.
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