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.

Ferric Derisomaltose 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.

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

Administration

Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Ferric Derisomaltose is single-dose only. Discard unused portion.

• Withdraw the appropriate volume of Ferric Derisomaltose and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP.
• Final diluted concentration should be more than 1 mg iron/mL.
• Compatibility of Ferric Derisomaltose with other drugs has not been established. Ferric Derisomaltose should not be mixed with or physically added to solutions containing other drugs.
• Administer the prepared solution via intravenous infusion over at least 20 minutes.
• Following dilution with 0.9% Sodium Chloride Injection, USP, Ferric Derisomaltose solution may be stored at room temperature for up to 8 hours.
• Extravasation of Ferric Derisomaltose may cause brown discoloration at the extravasation site which may be long lasting. Monitor for extravasation. If extravasation occurs, discontinue the Ferric Derisomaltose administration at that site.

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.

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

Overdose Effects

Excessive dosages of Ferric Derisomaltose may lead to the accumulation of iron in storage sites potentially leading to hemosiderosis and hemochromatosis. Avoid use of Ferric Derisomaltose in patients with iron overload.

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Ferric Derisomaltose. 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 Ferric Derisomaltose administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Ferric Derisomaltose when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Ferric Derisomaltose is contraindicated in patients with prior serious hypersensitivity reactions to Ferric Derisomaltose 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 Ferric Derisomaltose 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 Ferric Derisomaltose to patients with iron overload

Use in Special Populations

Pediatric Use: Safety and effectiveness have not been established in pediatric patients.

Pregnancy & Lactation

There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.

The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.