Sevelamer carbonate Zentiva
Active Substance: sevelamer carbonate
Common Name: sevelamer carbonate
ATC Code: V03AE02
Marketing Authorisation Holder: Genzyme Europe BV
Active Substance: sevelamer carbonate
Authorisation Date: 2015-01-15
Therapeutic Area: Hyperphosphatemia Renal Dialysis
Pharmacotherapeutic Group: All other therapeutic products
Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Sevelamer carbonate Zentiva 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.
Sevelamer carbonate Zentiva 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.
What is Sevelamer carbonate Zentiva and what is it used for?
Sevelamer carbonate Zentiva 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.
Sevelamer carbonate Zentiva 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.
How is Sevelamer carbonate Zentiva used?
Sevelamer carbonate Zentiva is available as tablets (800 mg) and as powder (2.4 g) in a sachet to be taken three 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. Sevelamer carbonate Zentiva 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 further information, see the package leaflet.
How does Sevelamer carbonate Zentiva work?
The active substance in Sevelamer carbonate Zentiva, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from the food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.
What benefits of Sevelamer carbonate Zentiva have been shown in studies?
Sevelamer carbonate Zentiva 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, Sevelamer carbonate Zentiva 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 approved medicine Renagel.
In a third main study in 49 adults who were not on dialysis, Sevelamer carbonate Zentiva reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.
Finally, a main study also showed that Sevelamer carbonate Zentiva was effective at lowering phosphate levels in 100 children: children who took Sevelamer carbonate Zentiva 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.
What are the risks associated with Sevelamer carbonate Zentiva?
The most common side effects with Sevelamer carbonate Zentiva (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation. For the full list of all side effects reported with Sevelamer carbonate Zentiva, see the package leaflet.
Sevelamer carbonate Zentiva 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 with Sevelamer carbonate Zentiva, see the package leaflet.
Why is Sevelamer carbonate Zentiva approved?
Studies show that Sevelamer carbonate Zentiva 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 Sevelamer carbonate Zentiva’s benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Zentiva?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sevelamer carbonate Zentiva have been included in the summary of product characteristics and the package leaflet.
Other information about Sevelamer carbonate Zentiva
The European Commission granted a marketing authorisation valid throughout the European Union for Sevelamer carbonate Zentiva on 15 January 2015. This authorisation was based on the authorisation granted to Renvela in 2009 (‘informed consent’).
For more information about treatment with Sevelamer carbonate Zentiva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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