Feraheme is an iron Infusion preparation containing the active substance ferumoxytol. The drug is available in the form of a solution for injection.
Feraheme is used to treat anemia (low levels of red blood cells or hemoglobin) that is due to iron deficiency in patients with chronic kidney disease (long-term, progressive worsening of kidney function).
This medicine can only be obtained with a prescription.
How to Take ?
Feraheme should only be given when medical staff trained in dealing with anaphylactic shock (a serious allergic reaction) are available.
Feraheme is given as an injection into a vein. A second injection can be given two to eight days after the first dose, depending on the severity of the anemia and body weight. The physician must ensure that the patient is observed for adverse effects for at least 30 minutes after the injection.
The blood and iron content of the patients should be tested at least one month after treatment. To maintain a normal hemoglobin level, patients may be given a re-treatment with Feraheme if they are confirmed to have an iron deficiency.
How Does it Work?
Anemia due to iron deficiency is common in patients with chronic kidney disease; the iron deficiency is caused by many factors, such as poor absorption of the iron present in food.
Ferumoxytol, the active substance in Feraheme, contains iron. After injection into the bloodstream, the drug is taken up by the liver, the spleen and the bone marrow, where the iron is then released and the depleted iron supply of the body is supplemented. Once the iron storage is full again, the body can produce more hemoglobin, which helps to remedy the anemia.
The effects of Feraheme were first tested in experimental models before being studied in humans.
Feraheme has been studied in three main studies involving 838 patients with chronic kidney disease and anemia due to iron deficiency, compared with treatment with orally administered iron. The main measure of effectiveness was the increase in hemoglobin levels after five weeks.
Benefit Shown During the Studies
Feraheme was more effective in increasing iron levels than treatment with orally administered iron. In all three studies, the patients who took Renso had on average a greater increase in hemoglobin levels: 1.2 g / d versus 0.5 g / d; 0.8 g / d versus 0.2 g / d; and 1.0 g / d versus 0.5 g / d.
In the studies, side effects were observed in 7.9% of patients receiving Feraheme, of whom 0.2% were considered severe. The most common side effects were gastrointestinal symptoms (diarrhea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), which in all cases occurred in less than 2.5% of patients.
Severe hypersensitivity (allergic reaction) or hypotension were uncommon and were observed in 0.2% of patients. For the full list of all side effects reported with Feraheme, see the package leaflet.
Feraheme should not be used in people who are hypersensitive (allergic) to ferumoxytol, any other ingredients or other iron preparations. It should also not be used in patients with iron overload (too much iron elsewhere in the body) or in patients whose anemia is not caused by iron deficiency.
Why is it approved?
Feraheme was found to work better than orally administered iron for the treatment of anemia due to iron deficiency in patients with chronic kidney disease. The increase in hemoglobin level observed in the studies was considered a valuable improvement and comparable to the result of standard intravenous iron preparations. With regard to the safety Feraheme appeared to be equivalent to other intravenous iron preparations and preferred over orally administered iron. The CHMP/FDA therefore concluded that Feraheme’s benefits are greater than its risks and recommended that Feraheme be given marketing authorization.
- Feraheme : in United States and Canada
- Rienso : in Finland, Ireland, Poland and Slovenia