Ferric derisomaltose

Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have non-hemodialysis-dependent chronic kidney disease (NDD-CKD) MONOFERRIC 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.

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.

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric as an intravenous infusion. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight as an intravenous infusion. Repeat Monoferric treatment if iron deficiency anemia reoccurs.

Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components. Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity to Monoferric or any of its components.

Hypersensitivity Reactions: Monitor patients for signs and symptoms of hypersensitivity during and after Monoferric administration for at least 30 minutes and until clinically stable following completion of the infusion. Iron Overload: Do not administer Monoferric to patients with iron overload.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions. Iron Overload. Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

Store at 20° C to 25°C (68°F to 77°F), excursions permitted to 15° C to 30°C (59°F to 86°F). See the USP controlled room temperature. Do not freeze.