What is Sevelamer carbonate Zentiva - sevelamer carbonate and what is it used for?
Sevelamer carbonate Zentiva is indicated for the control of hyperphosphataemia (high levels of phosphate in the blood) in:
- adult patients undergoing dialysis (a blood purification technique). The medicine can be used in patients undergoing hemodialysis (with a blood filtration machine) or peritoneal dialysis (in which fluid is pumped into the abdomen and an inner membrane of the body filters the blood);
- adult patients with chronic kidney disease (long-term) who are not on dialysis and have a serum phosphate level (blood) equal to or greater than 1.78 mmol / l.
Sevelamer carbonate Zentiva should be used with other treatments, such as calcium supplements and vitamin D, to prevent the development of bone diseases. Sevelamer carbonate Zentiva contains the active substance sevelamer carbonate . This medicine is similar to Renvela, already authorized in the European Union (EU). The manufacturer of Renvela has considered that its scientific data can be used for Sevelamer carbonate Zentiva ("informed consent").
How is Sevelamer carbonate Zentiva - sevelamer carbonate used?
Sevelamer carbonate Zentiva is available as tablets (800 mg) and as a powder (2.4 g) to be reconstituted in an oral suspension. The medicine can only be obtained with a prescription. The recommended starting dose of Sevelamer carbonate Zentiva depends on the clinical needs and level of phosphate in the blood and is between 2.4 and 4.8 g per day. Sevelamer carbonate Zentiva should be taken three times a day, with meals, and patients should follow the prescribed diet. The dose of Sevelamer carbonate Zentiva must be adapted every 2-4 weeks to reach an acceptable level of phosphate in the blood, which must subsequently be kept under control regularly. The tablets should be taken whole and the oral suspension should be taken within 30 minutes of preparation.
How does Sevelamer carbonate Zentiva - sevelamer carbonate work?
Patients with severe kidney disease are unable to eliminate phosphate from the body. This leads to hyperphosphatemia, which in the long run can cause complications such as heart disease. The active ingredient in Sevelamer carbonate Zentiva, sevelamer carbonate, is a phosphate binder. When the medicine is taken with meals, the sevelamer molecules contained in sevelamer carbonate bind to the phosphate of food in the intestine, preventing it from being absorbed into the body, This helps to reduce phosphate levels in the blood.
What benefit has Sevelamer carbonate Zentiva - sevelamer carbonate shown during the studies?
Sevelamer carbonate Zentiva has been shown to be as effective as another medicine, Renagel (which contains sevelamer in the form of hydrochloride salt) in reducing blood phosphate levels in patients with chronic kidney disease who were on dialysis. In two crossover studies, 110 patients (all previously treated with a phosphate binder-based oral therapy and who took a large majority of vitamin D) were treated for 4-8 weeks with Sevelamer carbonate Zentiva or Renagel, and subsequently assigned to the other therapy. In the two studies, the average amount of phosphate in the blood during treatment with Sevelamer carbonate Zentiva or Renagel was similar. Another study examined the efficacy of Sevelamer carbonate Zentiva in 49 patients with elevated blood phosphate levels (equal to or greater than 1.78 mmol / l) not undergoing dialysis. After eight weeks of treatment, the average amount of phosphate in the blood had decreased by about a fifth, from 2.0 mmol / l to 1.6 mmol / l.
What is the risk associated with Sevelamer carbonate Zentiva - sevelamer carbonate?
The most common side effects with Sevelamer carbonate Zentiva (seen in more than 1 patient in 10) are nausea, vomiting, upper abdominal pain (stomach ache) and constipation. Sevelamer carbonate Zentiva should not be used in people with hypophosphataemia (low levels of phosphate in the blood) or with intestinal obstruction (blockage in the intestine). For the full list of all side effects and restrictions with Sevelamer carbonate Zentiva, see the package leaflet.
Why has Sevelamer carbonate Zentiva - sevelamer carbonate been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Sevelamer carbonate Zentiva outweigh the identified risks and recommended that they be approved for use in the EU. The CHMP noted that treatment with Sevelamer carbonate Zentiva is effective in reducing blood phosphate levels without posing important safety risks. Although aware that the study conducted in patients who were not on dialysis was of limited size, the committee determined that the medicine can also be used in these subjects, since they had the same underlying disease as dialysis patients and therefore, a similar level of effectiveness can be envisaged.
What measures are being taken to ensure the safe and effective use of Sevelamer carbonate Zentiva - sevelamer carbonate?
A risk management plan has been developed to ensure that Sevelamer carbonate Zentiva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Sevelamer carbonate Zentiva, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Sevelamer carbonate Zentiva will ensure that information materials for patients and healthcare professionals are available in all Member States. These materials will include information on the risk and prevention of peritonitis (inflammation of the lining of the abdomen) in subjects who are on peritoneal dialysis, arteriovenous fistula (an abnormal access between artery and vein) in patients undergoing hemodialysis and vitamin deficiency in patients with chronic kidney diseases.
More information on Sevelamer carbonate Zentiva - sevelamer carbonate
On 15 January 2015, the European Commission issued a marketing authorization for Sevelamer carbonate Zentiva, valid throughout the European Union. The full EPAR for Sevelamer carbonate Zentiva can be found on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Sevelamer carbonate Zentiva therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 01-2015.
