PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Bindren - Colestilano?
BindRen is a medicine that contains the active substance cholestilan. It is available in tablets (1 g) and granules (sachets containing 2 or 3 g).
What is Bindren used for?
BindRen is indicated for the control of hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease undergoing dialysis (a blood clearance technique). It is used in patients undergoing hemodialysis (using a machine for filter the blood) or peritoneal dialysis (in which fluid is pumped into the abdomen and a membrane inside the body filters the blood).
The medicine can only be obtained with a prescription.
How is Bindren used?
The recommended starting dose of BindRen is 6 - 9 g per day, divided into three equal doses to be taken with or immediately after a meal. The dose of BindRen should be adjusted every two to three weeks up to a maximum of 15 g per day to obtain an acceptable level of phosphate in the blood, which should then be monitored regularly. Patients should continue to follow their prescribed low phosphate diet.
How does Bindren - Colestilan work?
Patients with severe kidney disease are unable to eliminate phosphate from the body. This condition is the cause of hyperphosphatemia, which can cause long-term complications such as heart or bone disease. The active substance in BindRen, cholestilan, it is a substance that binds phosphate. When taken with meals, cholestilan binds to the phosphate contained in food in the intestine, preventing its absorption into the body. This action helps to reduce phosphate levels in the blood.
How has Bindren - Colestilan been studied?
The effects of BindRen were first tested in experimental models before being studied in humans.
BindRen has been studied in two main studies involving 273 adults with long-term kidney disease and hyperphosphataemia. All patients were on dialysis and had been taking BindRen for three months.
A third main study involving 642 patients compared them with placebo (a dummy treatment)
effects of administering BindRen at various doses for three months. All the studies looked at the change in the average amount of phosphate in the blood after three months.
What benefit has Bindren - Colestilan shown during the studies?
The first two studies showed that BindRen was effective in controlling blood phosphate levels in patients with long-term kidney disease undergoing dialysis. In the first study, an average dose of 11.5 g of BindRen reduced blood phosphate levels by an average of 0.36 mmol / L after three months.
Similarly, in the second study, an average dose of 13.1 g of BindRen resulted in an average reduction in blood phosphate level of 0.50 mmol / L after three months.
The third study found that BindRen was more effective than placebo at doses of 6, 9, 12 and 15 g / day: compared to placebo, the reduction in blood phosphate levels observed with BindRen was 0, respectively. 16, 0.21, 0.19 and 0.37 mmol / l.
What is the risk associated with Bindren - Colestilan?
In clinical studies, about 3 out of 10 patients experienced at least one side effect. The most serious side effects with BindRen were gastrointestinal haemorrhage (bleeding in the stomach and intestines) and constipation. The most frequently reported side effects were nausea, dyspepsia (heartburn) and vomiting. For the full list of side effects detected with BindRen, see package leaflet.
BindRen should not be used in people who are hypersensitive (allergic) to cholestilan or any of the other ingredients. It must not be used in people with intestinal obstruction (blockage).
Why has Bindren - Colestilano been approved?
The CHMP noted that treatment with BindRen has a beneficial effect in reducing phosphate levels. There were no serious safety concerns and the overall safety profile was similar to that of other phosphate binders, as side effects mainly affected the gut and resolved spontaneously. The CHMP decided that the benefits of BindRen exceeds its risks and has recommended that the medicine be given a marketing authorization.
What measures are being taken to ensure the safe use of Bindren - Colestilano?
The company that markets Tresiba will provide educational material to healthcare professionals who are expected to administer or prescribe the medicines to patients with diabetes, in particular to make them aware of the high-dose formulation of Tresiba. It will also produce educational material to instruct patients on the correct use of Tresiba, which should be provided by the treating physician along with appropriate training.
More information about Bindren - Colestilan
On 21 January 2013, the European Commission issued a "Marketing Authorization" for BindRen, valid throughout the European Union.
For more information about BindRen therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 01-2013.
The information on Bindren - Colestilano published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
