What are the dosing suggestions for Monoferric (ferric derisomaltose) in patients with iron deficiency anemia?

Monoferric (Ferric Derisomaltose) Dosing Recommendations

For patients weighing ≥50 kg, administer 1000 mg of Monoferric as a single intravenous infusion over at least 20 minutes, and repeat the dose if iron deficiency anemia recurs. 1

Weight-Based Dosing Algorithm

Patients ≥50 kg:

• Standard dose: 1000 mg as single infusion over at least 20 minutes 1
• For severe anemia (Hb ≤10 g/dL): Consider 1500 mg as single dose based on European Society of Cardiology recommendations 2
• Repeat dosing when iron deficiency anemia recurs 1

Patients <50 kg:

• Administer 20 mg/kg actual body weight as single infusion over at least 20 minutes 1
• Alternative guideline-based approach: 500 mg for Hb >10 g/dL or 1000 mg for Hb ≤10 g/dL 2

Infusion Rate Requirements

• Doses ≤1000 mg: Infuse over at least 20 minutes 1
• Doses >1000 mg: Infuse over 30 minutes or more 2
• Dilute in 100-500 mL of 0.9% sodium chloride (final concentration >1 mg iron/mL) 1

Critical Safety Considerations

Monitor patients for hypersensitivity reactions during and for at least 30 minutes after infusion completion. 1

• Only administer when personnel and therapies for treating serious hypersensitivity reactions are immediately available 1
• Serious/severe hypersensitivity reactions occurred in 0.3% of patients in clinical trials 1
• Contraindicated in patients with prior serious hypersensitivity to Monoferric 1

Monitoring and Follow-Up

Initial Assessment (4-8 weeks post-infusion):

• Do not evaluate iron parameters within first 4 weeks after administration, as circulating iron interferes with assay results 2
• At 4-8 weeks: Check CBC, ferritin, and transferrin saturation 2
• Hemoglobin should increase by 1-2 g/dL within 4-8 weeks 2

Long-Term Monitoring:

• Check ferritin and transferrin saturation at 3 months after initial treatment 2
• Monitor for recurrent iron deficiency every 3 months for at least one year after correction 2
• Subsequently monitor between 6-12 months 2

Re-Treatment Criteria

Initiate repeat dosing when:

• Serum ferritin drops below 100 μg/L, OR 2
• Hemoglobin falls below 12 g/dL (women) or 13 g/dL (men) 2
• Iron deficiency anemia recurs 1

Special Population Considerations

Chronic Kidney Disease (NDD-CKD):

• Monoferric is specifically FDA-approved for non-hemodialysis dependent CKD 1
• Use standard weight-based dosing (20 mg/kg for <50 kg patients) 1
• Demonstrated fewer cardiovascular adverse events compared to iron sucrose in this population 3

Contraindications and Precautions:

• Do not administer if hemoglobin >15 g/dL 2
• Contraindicated in patients with iron overload 1
• Monitor for extravasation, which may cause long-lasting brown discoloration 1

Comparative Advantages

Monoferric is the only FDA-approved IV iron formulation for total dose infusion, allowing complete iron repletion in a single visit rather than multiple administrations. 2 This represents a significant logistic advantage over iron sucrose, which requires up to 5 separate 200 mg infusions. 3 Additionally, ferric derisomaltose carries a lower risk of hypophosphatemia compared to ferric carboxymaltose, making it safer for repeated use. 4