Indications & Uses
Derisofer is indicated for:
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Dosage For patients weighing 50 kg or more: Administer 1,000 mg of Ferric Derisomaltose by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.For patients weighing less than 50 kg: Administer Ferric Derisomaltose as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs.The dosage of Ferric Derisomaltose is expressed in mg of elemental iron. Each mL of Ferric Derisomaltose contains 100 mg of elemental iron. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions
Side Effects
Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.
Cautions & Contraindications
Warnings & Precautions
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
Contraindications
Ferric Derisomaltose is contraindicated in patients with a history of serious hypersensitivity to Ferric Derisomaltose or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse.