Basic Information
V03AE02
sevelamer
All other therapeutic products
Therapeutic 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.
Overview Summary
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.
Active Substances (2)
sevelamer carbonate
sevelamer carbonate
Documents (14)
Renvela : EPAR - Product Information
August 12, 2009
DRUG_PRODUCT_INFORMATION
Renvela : EPAR - Public assessment report
June 22, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Committee for medicinal products for human use, summary of positive opinion for Renvela
March 18, 2009
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Renvela : EPAR - Risk management plan
January 9, 2024
RISK_MANAGEMENT_PLAN_SUMMARY
Renvela : EPAR - Public assessment report
June 22, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Committee for medicinal products for human use, summary of positive opinion for Renvela
March 18, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela-H-C-PSUSA-00002697-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
August 29, 2016
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela-H-C-PSUSA-00002697-201810 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
September 3, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela : EPAR - Procedural steps taken and scientific information after authorisation
August 12, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP post-authorisation summary of positive opinion for Renvela (WS/965)
May 22, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela-H-C-993-P46-0023 : EPAR - Assessment Report
May 10, 2016
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela : EPAR - All Authorised presentations
June 22, 2009
AUTHORISED_PRESENTATIONS
Renvela-H- C-993-WS-0965 : EPAR - Assessment Report - Variation
July 25, 2017
CHANGES_SINCE_INITIAL_AUTHORISATION
Renvela : EPAR - Medicine overview
June 22, 2009
OVERVIEW_DOCUMENT
Overview Q&A (7)
Question
How is Renvela used?
Answer
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.
Question
How does Renvela work?
Answer
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.
Question
What benefits of Renvela have been shown in studies?
Answer
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.
Question
What are the risks associated with Renvela?
Answer
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.
Question
Why is Renvela authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Renvela?
Answer
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.
Question
Other information about Renvela
Answer
Renvela received a marketing authorisation valid throughout the EU on 10 June 2009.