What is Velphoro - sucroferrico oxyhydroxide?
Velphoro is a medicine used to control blood phosphorus levels in adult patients with long-term kidney disease who are undergoing hemodialysis or peritoneal dialysis to eliminate waste from the blood. Velphoro is used in combination with other treatments, including calcium supplements or vitamin D, which help control bone diseases related to kidney failure and high phosphorus levels. The active ingredient in this medicine is sucroferric oxyhydroxide (also known as a mixture of polynuclear iron (III) oxyhydroxide, sucrose (sugar) and starches).
How is Velphoro - sucroferric oxyhydroxide used?
Velphoro is available as chewable tablets (containing 500 mg of iron). The recommended starting dose is 1 500 mg (3 tablets) per day, divided into doses taken during the day's meals. The dose of Velphoro must be adjusted every 2-4 weeks, until an acceptable level of phosphorus in the blood is reached, which must then be monitored. The maximum dose is 3, 000 mg (6 tablets) per day. Patients should follow the prescribed low phosphorus diet. The tablets should be chewed and not swallowed whole. The medicine can only be obtained with a prescription.
How does Velphoro - sucroferric oxyhydroxide work?
Patients with severe renal insufficiency are unable to remove phosphorus from the body. The consequence is hyperphosphataemia (high phosphate level in the blood) which in the long term can cause complications such as heart disease and bone diseases. The active ingredient of Velphoro, sucroferric oxyhydroxide, is a phosphate binder. Taken at meals, the iron contained in Velphoro binds to the phosphate present in the food that passes through the intestine, preventing it from being absorbed into the body and thus helping to keep blood phosphate levels low.
What benefit has Velphoro - sucroferric oxyhydroxide shown during the studies?
Velphoro has been studied in a main study involving 1, 509 adults with chronic renal failure and hyperphosphataemia. All patients were on dialysis and were treated with Velphoro or sevelamer, another phosphate binder, for 6 months. After 6 months, more than half of the patients could continue the same treatment for a maximum period of one year, while a smaller group received Velphoro at a lower dose for three weeks only. The study examined changes in the level of phosphate in the blood, measured in units of mmol / L. Velphoro was as effective as sevelamer in reducing phosphate levels in patients' blood and maintaining this effect over time. After 3 months of treatment, blood phosphate levels decreased on average by 0.7 mmol / L with Velphoro compared to 0.8 mmol / L with sevelamer, while after 6 months of treatment 53% of patients treated with Velphoro showed normal phosphate levels (between 1.13 and 1.78 mmol / L) compared to 54% of patients treated with sevelamer. In subjects whose dose of Velphoro was subsequently decreased, blood phosphate levels increased after 3 weeks, while in those who continued to take the same dose for up to a year the levels remained stable.
What is the risk associated with Velphoro - sucroferrico oxyhydroxide?
The most common side effects of Velphoro (which may affect more than 1 in 10 people) are diarrhea and hypochromic stools, which may become less frequent if continued therapy. Velphoro should not be used in patients with iron accumulation disorders such as haemochromatosis. For the full list of all side effects and restrictions with Velphoro, see the package leaflet
Why has Velphoro - sucroferric Bone Hydroxide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Velphoro's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Velphoro showed a clear beneficial effect in reducing phosphate levels. No critical aspects of safety emerged and, although tolerability is slightly lower than sevelamer, the overall safety profile was acceptable. The risk of an abnormal accumulation of iron has been considered limited, but must be kept under control after authorization.
What measures are being taken to ensure the safe and effective use of Velphoro - sucroferrico oxyhydroxide?
A risk management plan has been developed to ensure that Velphoro 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 Velphoro, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
Further information on Velphoro - sucroferric oxyhydroxide
On 26 August 2014, the European Commission issued a marketing authorization for Velphoro, valid throughout the European Union. For more information on Velphoro therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 08-2014.
