FDA approved Monoferric (ferric derisomaltose) for Iron Deficiency Anemia in AdultsFDA approved New Single-Dose IV Iron Treatment for Anemia

Not reported in label.

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 - who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric as a single intravenous infusion over at least 20 minutes. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight as a single intravenous infusion over at least 20 minutes. Repeat dose if iron deficiency anemia reoccurs. The dosage is expressed in mg of elemental iron. Each mL contains 100 mg of elemental iron. Dilute the appropriate volume in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP. Final diluted concentration should be more than 1 mg iron/mL. Administer via intravenous infusion over at least 20 minutes. Following dilution, the solution may be stored at room temperature for up to 8 hours. Discard unused portion. Do not mix with other drugs.

Trial 1 (NCT02940886): 1512 adults with IDA and intolerance or unsatisfactory response to oral iron, or low screening hemoglobin. Patients were randomized 2:1 to Monoferric 1000 mg IV or iron sucrose. Median age 44 years, 89% women. Mean change in Hb from baseline to week 8: 2.49 g/dL (95% CI 2.41;2.56) for Monoferric vs 2.49 g/dL (95% CI 2.38;2.59) for iron sucrose; difference 0.00 (95% CI -0.13;0.13), non-inferiority confirmed. Trial 2 (NCT02940860): 1538 patients with NDD-CKD randomized 2:1 to Monoferric or iron sucrose. Median age 69 years, 63% female. Mean change in Hb from baseline to week 8: 1.22 g/dL (95% CI 1.14;1.31) for Monoferric vs 1.14 g/dL (95% CI 1.03;1.26) for iron sucrose; difference 0.08 (95% CI -0.06;0.23), non-inferiority confirmed.

Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions. Monitor for extravasation; if extravasation occurs, discontinue administration at that site. Extravasation may cause brown discoloration at the site, which may be long lasting. The product contains no preservatives and is single-dose only. Compatibility with other drugs has not been established. Do not mix with or physically add to solutions containing other drugs.

Monoferric provides a single-dose intravenous iron option for adults with IDA who cannot tolerate or do not respond adequately to oral iron, and for those with NDD-CKD. The label does not provide comparative data on safety or other outcomes beyond the hemoglobin non-inferiority trials.