Does Monoferric (ferric derisomaltose) require premedication?

Monoferric (Ferric Derisomaltose) Does Not Require Routine Premedication

Monoferric (ferric derisomaltose) does not require routine premedication before administration as there is no evidence supporting its benefit for preventing hypersensitivity reactions.

Evidence on Monoferric Safety Profile

Ferric derisomaltose (Monoferric) has demonstrated a favorable safety profile with a very low incidence of adverse reactions:

• Real-world data from 7,354 patients showed only 1.7% experienced any adverse reactions, with hypersensitivity reactions occurring in just 0.4% and anaphylaxis in <0.1% of patients 1
• Anaphylaxis is extremely rare with ferric derisomaltose, and "Fishbane" reactions (non-allergic infusion reactions) are uncommon 2
• Compared to other IV iron formulations, ferric derisomaltose releases lower quantities of labile iron, contributing to its favorable safety profile 2

Premedication Recommendations for IV Iron

Current guidelines and evidence do not support routine premedication for IV iron preparations like Monoferric:

• The Joint Task Force on Practice Parameters (JTFPP) suggests against routinely administering glucocorticoids and/or antihistamines to prevent anaphylaxis when administering agents with low risk of hypersensitivity reactions 3
• Premedication has not been shown to provide clear benefit in preventing hypersensitivity reactions to various intravenous agents (risk ratio, 1.07; 95% CI, 0.67-1.71) 3
• Studies with other biological agents like infliximab have shown that premedication does not effectively prevent acute infusion reactions 4

Administration Guidelines for Monoferric

According to KDIGO guidelines, Monoferric (ferric derisomaltose) can be administered as:

• Single dose up to 20 mg/kg in Europe or 1000 mg in the US
• Infusion time of more than 15 minutes for doses up to 1000 mg
• Infusion time of 30 minutes or more for doses exceeding 1000 mg 3

Special Considerations

While routine premedication is not required, certain situations may warrant special consideration:

• Patients with a history of multiple drug allergies or previous severe hypersensitivity reactions to other IV iron preparations may benefit from individualized risk assessment
• Emergency medications and equipment should always be available when administering IV iron, regardless of premedication or allergy history 5
• Slow infusion rates can help reduce the risk of non-allergic complement activation-related pseudo-allergy (CARPA) reactions 6

Monitoring During Administration

During Monoferric administration:

• Monitor vital signs before, during, and after infusion
• Observe for signs of hypersensitivity reactions (urticaria, pruritus, hypotension, chest pain, dyspnea)
• Be prepared to discontinue the infusion immediately if symptoms of a reaction begin
• Have emergency medications (epinephrine, antihistamines, corticosteroids) readily available

Advantages of Monoferric

Monoferric offers several advantages over other IV iron formulations:

• Can be administered as a single high-dose infusion, allowing complete iron repletion in one visit
• Lower risk of hypophosphatemia compared to ferric carboxymaltose 6
• Demonstrates statistically significant increases in hemoglobin and ferritin levels within 4 months of treatment 1

In conclusion, Monoferric (ferric derisomaltose) does not require routine premedication before administration. However, standard emergency preparedness measures should be in place, as with any intravenous medication administration.