What is Feraccru - Maltolo Ferrico used for?
Feraccru is a medicine containing iron. It is indicated in the treatment of anemia (low levels of red blood cells or hemoglobin) caused by the lack of iron (iron deficiency), in adults suffering from inflammatory bowel diseases called "inflammatory bowel diseases" (eg, ulcerative colitis and Crohn's disease).
Feraccru contains the active ingredient ferric maltol.
How is Feraccru used - Maltolo Ferrico?
The medicine is available as capsules (30 mg). The recommended dose is one capsule twice a day, morning and evening, on an empty stomach. The duration of treatment depends on the severity of the iron deficiency, but generally it takes at least 12 weeks.
The medicine can only be obtained with a prescription.
How does Feraccru - Maltolo Ferrico work?
Iron deficiency anemia is a common problem in patients with inflammatory bowel disease. It is caused by various factors including bleeding and poor absorption of iron in food from the inflamed intestine of patients.
The active ingredient in Feraccru, ferric maltol, is an iron-containing compound. Taken orally, it is absorbed by the cells of the intestine; iron is then released from the compound, transported and stored in the body to help restore normal levels. Iron is an essential element for hemoglobin and the reintegration of its reserves helps the body to produce more hemoglobin and, consequently, to correct anemia.
What benefit has Feraccru - Maltol Ferric shown during the studies?
Feraccru was compared with a placebo (a dummy treatment) in a main study involving 128 patients with inflammatory bowel disease, with iron deficiency anemia defined as hemoglobin levels below 12.0 grams per deciliter (g / dl). The main measure of effectiveness was the measure of increased hemoglobin levels after 12 weeks of treatment.
Feraccru has been shown to be superior to placebo in terms of increasing hemoglobin levels: in patients taking Feraccru there was an average increase in hemoglobin levels from 11.0 to 13.2 g / dl while the levels of patients who took placebo remained stable around 11.1 g / dl. Furthermore, approximately 65% of patients receiving Feraccru achieved normal hemoglobin levels compared to 10% of patients who received placebo.
What is the risk associated with Feraccru - Maltolo Ferrico?
The most common side effects reported with Feraccru (affecting up to 1 in 10 people) are bowel symptoms such as abdominal pain (belly), flatulence (air passage), constipation, abdominal discomfort and distention, and diarrhea; these side effects are generally mild or moderate in severity.
Serious side effects include abdominal pain, constipation and diarrhea. For the full list of all side effects reported with Feraccru, see the package leaflet. Feraccru should not be used in patients with iron overload (haemochromatosis) or in patients undergoing repeated blood transfusions. For the full list of limitations, see the package leaflet.
Why has Feraccru - Maltol Ferric been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Feraccru's benefits are greater than its risks and recommended that it be approved for use in the EU. Feraccru has been shown to be effective in increasing hemoglobin levels in patients with inflammatory bowel disease and iron deficiency anemia. The safety profile of Feraccru is considered acceptable, with side effects largely of mild or moderate severity and similar to those of other iron-based preparations.
What measures are being taken to ensure the safe and effective use of Feraccru - Maltolo Ferrico?
A risk management plan has been developed to ensure that Feraccru 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 Feraccru, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Feraccru - Maltolo Ferrico
For the full version of EPAR and the summary of the Feraccru risk management plan, see the Agency website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information on Feraccru therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
