General Information

Monoferric (ferric derisomaltose) is an intravenous iron replacement product.

Monoferric is specifically 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, and in adult patients with non-dialysis dependent chronic kidney disease.

Monoferric is supplied as a solution for intravenous infusion. For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric 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 Monoferric 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 Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron.

Clinical Trials

FDA Approval

The FDA approval of Monoferric was based on two randomized, open-label clinical trials with active control (FERWON studies) performed in a total of 3050 patients with iron deficiency anemia (IDA) of different etiologies. Trial 1 (FERWON-IDA) included patients with IDA who had intolerance to oral iron or who had had unsatisfactory response to oral iron or for whom there was a clinical need for rapid repletion of iron stores. Trial 2 (FERWON-NEPHRO) included patients with IDA who had non-dialysis dependent chronic kidney disease. In these two 8-week trials, patients were randomized 2:1 to treatment with Monoferric or iron sucrose. Monoferric was intravenously administered as a single dose of 1000 mg.

In Trial 1, 1512 adult patients with IDA caused by different etiologies were randomized in a 2:1 ratio to treatment with Monoferric or iron sucrose. The efficacy of Monoferric was established based upon the change in Hb from baseline to week 8. Non-inferiority was demonstrated for change in Hb from baseline to Week 8. Patients in both arms of this study experienced a mean change in hemoglobin of 2.49 g/dL from baseline to week 8. These increases were statistically significant.

Trial 2 enrolled 1538 patients with NDD-CKD. The efficacy of Monoferric was established based upon the demonstration of non-inferiority for change in hemoglobin from baseline to Week 8. Patients receiving Monoferric experienced a mean increase in hemoglobin from baseline to Week 8 of 1.22 g/dL, and patients treated with iron sucrose experienced a mean increase in hemoglobin from baseline to Week 8 of 1.14 g/dL. Based upon these results, non-inferiority was confirmed.