How should Monoferric (ferric derisomaltose) IV be mixed and administered?

Monoferric (Ferric Derisomaltose) IV Mixing and Administration

Monoferric must be diluted in 100-500 mL of 0.9% Sodium Chloride Injection, USP, with a final concentration greater than 1 mg iron/mL, and administered as an intravenous infusion over at least 20 minutes. 1

Preparation Protocol

Visual Inspection and Handling

• Inspect the vial for particulate matter and discoloration before use 1
• Each vial is single-dose only; discard any unused portion as the product contains no preservatives 1
• The solution should appear as a sterile, dark brown, non-transparent aqueous liquid 1

Dilution Requirements

• Withdraw the appropriate volume of Monoferric based on the calculated dose 1
• Dilute in 100-500 mL of 0.9% Sodium Chloride Injection, USP only 1
• The final diluted concentration must be more than 1 mg iron/mL 1
• Do not mix with or physically add to solutions containing other drugs, as compatibility with other medications has not been established 1

Storage After Dilution

• Following dilution with 0.9% Sodium Chloride, the solution may be stored at room temperature for up to 8 hours 1
• Use within this timeframe to maintain stability and sterility 1

Dosing Guidelines

Weight-Based Dosing

• Patients ≥50 kg: Administer 1,000 mg as a single dose 1
• Patients <50 kg: Administer 20 mg/kg actual body weight as a single dose 1
• Each mL of Monoferric contains 100 mg of elemental iron 1

Repeat Dosing

• Repeat the dose if iron deficiency anemia recurs 1
• The frequency depends on the underlying etiology; if ongoing losses exist (such as heavy menstrual bleeding), repeated infusions may be necessary 2

Administration Protocol

Infusion Rate and Monitoring

• Administer over at least 20 minutes for all doses 1
• This minimum infusion time applies to both the 1,000 mg dose and weight-based doses up to 1,500 mg 2
• Monitor patients for signs and symptoms of hypersensitivity during and for at least 30 minutes after completion of the infusion and until clinically stable 1

Safety Requirements

• Only administer when personnel and therapies are immediately available for treatment of serious hypersensitivity reactions 1
• Slow infusion rates reduce the risk of complement activation-related pseudo-allergy (CARPA) reactions 3, 4

Critical Safety Considerations

Extravasation Management

• Monitor closely for extravasation during infusion 1
• Extravasation may cause brown discoloration at the site that can be long-lasting 1
• If extravasation occurs, immediately discontinue the Monoferric administration at that site 1

Contraindications

• Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components 1
• Previous reactions may have included shock, clinically significant hypotension, loss of consciousness, or collapse 1

Hypersensitivity Reactions

• Serious hypersensitivity reactions, including anaphylactic-type reactions (some life-threatening and fatal), have been reported 1
• In clinical trials, serious or severe hypersensitivity occurred in 0.3% (6/2008) of Monoferric-treated patients 1
• The incidence of severe hypersensitivity reactions is <1% and appears comparable to other modern IV iron formulations 3

Iron Overload Risk

• Do not administer to patients with iron overload 1
• Monitor hematologic response (hemoglobin and hematocrit) and iron parameters (serum ferritin and transferrin saturation) during therapy 1
• Excessive parenteral iron therapy can lead to iatrogenic hemosiderosis or hemochromatosis 1

Advantages of Ferric Derisomaltose

Hypophosphatemia Risk

• Ferric derisomaltose has a significantly lower risk of treatment-emergent hypophosphatemia compared to ferric carboxymaltose 3
• This makes it safer for patients requiring repeated infusions, as ferric carboxymaltose can cause severe osteomalacia with repeated use 3

Cardiovascular Safety

• In patients with chronic kidney disease, ferric derisomaltose was associated with fewer cardiovascular adverse events compared to iron sucrose (hazard ratio: 0.59; 95% CI: 0.37,0.92; p=0.0185) 5
• This benefit was consistent in patients with and without heart failure 5

Efficacy Profile

• Ferric derisomaltose provides a faster hematological response compared to multiple doses of iron sucrose 5
• It has been shown effective across multiple patient populations including chronic kidney disease, inflammatory bowel disease, and congestive heart failure 2, 6

Common Pitfalls to Avoid

• Never administer undiluted - always dilute in normal saline as specified 1
• Never mix with other medications in the same infusion bag 1
• Never infuse faster than 20 minutes - rapid infusion increases hypersensitivity risk 1
• Never use dextrose solutions for dilution - only 0.9% sodium chloride is approved 1
• Never administer without immediate access to resuscitation equipment and trained personnel 1