Derisofer

Derisofer is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients:
who have intolerance to oral iron or have had unsatisfactory response to oral iron.
who have non-hemodialysis dependent chronic kidney disease.

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Hypersensitivity Reactions
: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Derisofer. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after Derisofer administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Derisofer when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Derisofer is contraindicated in patients with prior serious hypersensitivity reactions to Derisofer or any of its components. In clinical trials in patients with IDA and CKD, serious or severe hypersensitivity were reported in 0.3% (6/2008) of the Derisofer treated subjects. These included 3 events of hypersensitivity in 3 patients; 2 events of infusion-related reactions in 2 patients and 1 event of asthma in one patient.
Iron Overload
: Excessive therapy with parenteral iron can lead to excess iron storage and possibly iatrogenic hemosiderosis or hemochromatosis. Monitor the hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during parenteral iron therapy. Do not administer Derisofer to patients with iron overload

This is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono- and disaccharides. Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose, an iron carbohydrate oligosaccharide that releases iron. Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.