What is the proper administration protocol for infusing Venofer (iron sucrose) intravenously?

From the Guidelines

Venofer (iron sucrose) should be administered intravenously by slow injection or infusion, with a maximum single dose of 200 mg, over a duration of 10 minutes, as licensed and more convenient than a 2-hour infusion 1. To administer Venofer safely and effectively, consider the following protocol:

• For IV injection, administer 100-200 mg over 2-5 minutes.
• For IV infusion, dilute 100-200 mg in a maximum of 100 mL of 0.9% sodium chloride and infuse over at least 15 minutes.
• Higher doses (300-500 mg) should be diluted in 250 mL of 0.9% sodium chloride and infused over 1.5-3.5 hours. Before administration, visually inspect the solution for particulate matter and discoloration. The first test dose (25 mg) should be given over 15 minutes with monitoring for adverse reactions. Subsequent doses can follow the standard protocol if no reactions occur. Monitor vital signs before, during, and after administration, watching for hypotension, flushing, or allergic reactions. Venofer should not be mixed with other medications or given through lines containing other drugs. This protocol ensures safe administration while minimizing the risk of adverse reactions, which can include hypersensitivity reactions due to the release of free iron from the iron-carbohydrate complex. It is essential to note that anaphylaxis may occur, and resuscitation facilities should be available for all these agents when given intravenously 1. Some key points to consider when administering Venofer include:
• The incidence of side effects with ferric carboxymaltose is similar to other intravenous compounds (22-29%), but no anaphylaxis has been reported to date 1.
• The cautions and contraindications found in the manufacturers’ instructions and in the British National Formulary should be noted.
• Although the initial rise in Hb is more rapid with parenteral iron, the rise in Hb at 12 weeks is similar to that observed during oral iron therapy 1.

From the FDA Drug Label

Venofer must only be administered intravenously either by slow injection or by infusion. Administer Venofer only intravenously by slow injection or by infusion. Administer Venofer 100 mg undiluted as a slow intravenous injection over 2 to 5 minutes, or as an infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes, per consecutive hemodialysis session Administer Venofer 200 mg undiluted as a slow intravenous injection over 2 to 5 minutes or as an infusion of 200 mg in a maximum of 100 mL of 0. 9% NaCl over a period of 15 minutes.

The proper administration protocol for infusing Venofer (iron sucrose) intravenously is by:

• Slow injection over 2 to 5 minutes
• Infusion of 100 mg diluted in a maximum of 100 mL of 0.9% NaCl over a period of at least 15 minutes for adult patients with Hemodialysis Dependent-Chronic Kidney Disease (HDD-CKD)
• Infusion of 200 mg in a maximum of 100 mL of 0.9% NaCl over a period of 15 minutes for adult patients with Non-Dialysis Dependent-Chronic Kidney Disease (NDD-CKD) 2 Key administration considerations:
• Dilute Venofer in 0.9% NaCl
• Do not dilute to concentrations below 1 mg/mL
• Administer early during the dialysis session (generally within the first hour) for HDD-CKD patients 2

From the Research

Administration Protocol for Venofer (Iron Sucrose)

To infuse Venofer (iron sucrose) intravenously, the following protocol should be considered:

• The dosage of iron sucrose can vary depending on the patient's condition and the severity of iron deficiency anemia 3.
• A dose of 200-300 mg of iron sucrose administered over 2 hours appears to be safe, with no adverse events reported in clinical trials 3.
• Higher doses, such as 400-500 mg, may be associated with a higher incidence of adverse events, including dizziness, hypotension, and nausea 3.
• Iron sucrose can be administered as a replacement regimen, with 100 mg given during 10 consecutive hemodialysis sessions, or as a maintenance regimen, with 100 mg given weekly for 10 weeks 4.

Safety Considerations

When administering iron sucrose, the following safety considerations should be taken into account:

• Iron sucrose is generally well-tolerated, with no moderate or serious adverse drug reactions reported in clinical trials 5.
• However, all iron preparations are associated with a risk of severe infusion reactions, which can occur in less than 1% of patients 6.
• Patients should be monitored for signs of adverse reactions, such as dizziness, hypotension, and nausea, during and after infusion 3.

Clinical Experience and Efficacy

Iron sucrose has been used clinically for over 70 years, with a wealth of experience in treating iron deficiency anemia 7.

• Treatment with iron sucrose has been shown to rapidly increase hemoglobin, ferritin, and transferrin saturation levels, with an acceptable safety profile 7.
• Clinical trials have demonstrated the efficacy and safety of intravenous iron sucrose in treating adults with iron deficiency anemia, with significant increases in hemoglobin and serum ferritin levels reported 5.