Monoferric (Ferric Derisomaltose) Dosing Protocol
Ferric derisomaltose (Monoferric) should be administered as a single intravenous infusion of 1,000 mg for patients weighing 50 kg or more, or 20 mg/kg for patients weighing less than 50 kg, infused over at least 20 minutes. 1
Standard Dosing Recommendations
- For patients weighing 50 kg or more: Administer 1,000 mg as a single intravenous infusion 1
- For patients weighing less than 50 kg: Administer 20 mg/kg actual body weight as a single intravenous infusion 1
- Dilute Monoferric in 100-500 mL of 0.9% Sodium Chloride Injection, USP (final diluted concentration should be more than 1 mg iron/mL) 1
- Administer the prepared solution via intravenous infusion over at least 20 minutes 1
- Repeat dose if iron deficiency anemia recurs 1, 2
Preparation and Administration
- Inspect visually for particulate matter and discoloration prior to administration 1
- Each vial is single-dose only; discard unused portion 1
- Following dilution with 0.9% Sodium Chloride Injection, USP, the solution may be stored at room temperature for up to 8 hours 1
- Monitor for extravasation which may cause brown discoloration at the site 1
- Monitor patients for signs and symptoms of hypersensitivity during and for at least 30 minutes after infusion 1
Advantages of Ferric Derisomaltose
- Ferric derisomaltose is the only IV iron formulation with FDA approval for total dose infusion 2
- Single-infusion administration offers convenience, eliminates adherence concerns, and reduces healthcare resource utilization 3
- Provides rapid iron repletion with low rates of serious or severe hypersensitivity reactions 3
- Associated with fewer cardiovascular events compared to iron sucrose 4
- Demonstrates a statistically significant reduction in death from cardiovascular events in patients with congestive heart failure 2
- Shows a more rapid and pronounced hematological response compared to multiple doses of iron sucrose 5
Follow-up Monitoring
- Laboratory evaluation following IV iron should include a complete blood count (CBC) and iron parameters (ferritin, percent transferrin saturation) 4 to 8 weeks after infusion 2
- Do not evaluate iron parameters within the first 4 weeks after administration 2
- Monitor hematologic response and iron parameters to prevent excess iron storage 1
Safety Considerations
- Contraindicated in patients with history of serious hypersensitivity to Monoferric or any of its components 1
- Do not administer to patients with iron overload 1
- Administer only when personnel and therapies are immediately available for treatment of serious hypersensitivity reactions 1
- Incidence of serious or severe hypersensitivity reactions is low (0.3% in clinical trials) 1, 5
- Has lower risk of hypophosphatemia compared to ferric carboxymaltose 6
Clinical Context
- Ferric derisomaltose is indicated for treatment of iron deficiency anemia in adult patients who have intolerance to oral iron, unsatisfactory response to oral iron, or non-hemodialysis dependent chronic kidney disease 1
- Effective across multiple conditions including chronic kidney disease, pregnancy, inflammatory bowel disease, and congestive heart failure 2
- Frequency of administration depends on the underlying etiology of iron deficiency; a single total dose infusion may suffice if the cause has been eliminated 2