RIENSO - FERUMOXYTOL - MEDICATIONS

How is Rienso - Ferumoxytol used?

It should only be given when healthcare professionals are available to treat anaphylactic (severely allergic) reactions.
Rienso is administered by intravenous injection. Depending on the severity of the anemia and body weight, a second injection may be given two to eight days after the first dose. The physician should ensure that the patient remains under observation for any side effects for at least 30 minutes after the first dose. "injection. Patients should be tested for blood and iron levels at least one month after treatment. Patients with known iron deficiency can be re-treated with Rienso to maintain normal hemoglobin levels.

How does Rienso - Ferumoxytol work?

Iron deficiency is a common cause of anemia in patients with long-term kidney disease and is caused by many factors, including poor iron absorption from food.
The active substance in Rienso, ferumoxytol, is an iron-containing compound. When it is injected into the blood, it is absorbed by the cells of the liver, spleen and bone marrow; at this point, the iron released by the compound replenishes the body's depleted iron reserves. Once the iron stores are replenished, the body is able to produce hemoglobin, which helps to correct the anemia.

How has Rienso - Ferumoxytol been studied?

Before being studied in humans, the effects of Rienso were tested in experimental models.
Rienso has been compared with iron-based treatment taken by mouth in three main studies involving 883 chronic kidney disease patients with iron deficiency anemia. The main measure of effectiveness was the measure of the increase in hemoglobin levels after five weeks.

What is the risk associated with Rienso - Ferumoxytol?

In studies with Rienso, undesirable effects were seen in 7.9% of patients treated with the medicine, of which 0.2% were considered serious. The most common side effects were intestinal symptoms (diarrhea, constipation, nausea and vomiting), headache, dizziness and hypotension (low blood pressure), all occurring in less than 2.5% of patients. Uncommon were serious cases of hypersensitivity (allergic reaction) or hypotension, observed in 0.2% of patients. For the full list of side effects seen with Rienso, see the package leaflet.
Rienso must not be used in people who are hypersensitive (allergic) to ferumoxytol, to any of the other ingredients of the medicine or to any other iron preparations. It must not be used in patients who have been found to have excess iron in the body or in patients whose anemia is not caused by iron deficiency.

Why has Rienso - Ferumoxytol been approved?

Rienso was superior to iron taken by mouth in the treatment of iron deficiency anemia in patients with chronic kidney disease. The increase in hemoglobin levels observed in the main studies was considered by the CHMP to be a useful and comparable improvement to that obtained by administering standard intravenous preparations. Regarding safety, Rienso was similar to other intravenous iron preparations and more favorable than oral iron treatments. The CHMP decided that Rienso's benefits are greater than its risks and recommended that it be given a 'Marketing Authorization' for the medicine.

Other information about Rienso - Ferumoxytol

On 15 June 2012, the European Commission issued a "marketing authorization" for Rienso, valid throughout the European Union.
For the complete version of Rienso's EPAR, consult the Agency's website: ema.Europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Rienso therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 05-2012.

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