Fexeric

What is Fexeric and what is it used for?

Fexeric is a medicine used to control hyperphosphataemia (high levels of phosphate in the blood) in adults with long-term kidney disease. Contains the complex coordination principle of ferric citrate.

How is Fexeric used?

Fexeric is available as 1 g tablets. The recommended starting dose is 3-6 tablets per day, taken in divided doses during meals. The maximum dose is 12 tablets per day. Blood phosphate levels should be monitored periodically during treatment. Patients should follow the low phosphate diet prescribed for them.

The medicine can only be obtained with a prescription. For more information, see the package leaflet.

How does Fexeric work?

Patients with severe kidney disease have difficulty eliminating phosphate from the body. An accumulation of phosphate is at the origin of hyperphosphatemia, which in the long term can cause complications such as heart and bone diseases.

The active ingredient of Fexeric, the coordination complex of ferric citrate, is a substance capable of binding phosphate. When the medicine is taken during meals, the iron contained in Fexeric binds to the phosphate of the foods inside the intestine, forming a compound that is subsequently eliminated with the feces. This prevents the absorption of phosphate into the body, thus helping to keep blood phosphate levels low.

What benefit has Fexeric shown during the studies?

Fexeric has been shown to be effective in controlling blood phosphate levels in 2 main studies involving patients with long-term kidney disease and hyperphosphataemia. Both studies examined changes in the level of phosphate in the blood, measured in mg / dl.

In the first study, Fexeric was as effective as sevelamer carbonate, an authorized medicine, in reducing phosphate levels in 359 patients with long-term kidney disease: after 12 weeks both therapies led to a reduction in phosphate levels of about 2 mg / dl.

In the second study, 149 non-dialysis patients were treated with Fexeric or placebo for 3 months. The study found that blood phosphate levels decreased on average by 0.7 mg / dl with Fexeric compared to the 0.3 mg / dl reduction seen with placebo.

What is the risk associated with Fexeric?

The most common side effects of Fexeric (which may affect more than 1 in 10 people) are changes in the evacuation (diarrhea or constipation) and discolored stools. Serious side effects have occurred with uncommon frequency and have mainly affected bowel and stomach. For the full list of all side effects reported with Fexeric, see the package leaflet.

Fexeric should not be used in patients with low blood phosphate levels, in patients suffering from severe stomach and bowel problems (including intestinal bleeding) and in patients with iron accumulation disorders such as haemochromatosis. For the full list of limitations, see the package leaflet.

Why has Fexeric been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Fexeric's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP is of the opinion that Fexeric is effective in controlling blood phosphate levels in patients with long-term kidney disease, undergoing dialysis or not. The overall safety profile was considered acceptable and comparable to that of other substances capable of binding phosphate.

What information is still awaited for Fexeric?

A risk management plan has been developed to ensure that Fexeric 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 Fexeric, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Fexeric will conduct a study to learn more about the long-term safety of the medicine, particularly in elderly patients.