What is the relationship between intravenous (I/V) iron administration and hemodialysis?

From the Guidelines

Intravenous (IV) iron administration should be used judiciously in hemodialysis patients, with a target ferritin level between 200-500 ng/mL, to minimize the risk of iron overload and its associated morbidity and mortality. The use of IV iron in hemodialysis patients has increased significantly over the past two decades, with a rise in the proportion of patients receiving IV iron from 64% in 2002 to 76% in 2008 1. However, recent studies have suggested that excessive IV iron may increase mortality and cardiovascular events in hemodialysis patients 1. The KDIGO 2012 guideline recommends a target ferritin level between 200-500 ng/mL, and emphasizes the importance of monitoring iron status regularly to avoid iron overload 1.

Some key points to consider when administering IV iron to hemodialysis patients include:

• Using the lowest effective dose of IV iron to minimize the risk of iron overload
• Monitoring iron status regularly with ferritin and transferrin saturation tests
• Avoiding the use of IV iron in patients with ferritin levels above 500 ng/mL
• Considering alternative treatments, such as oral iron or erythropoiesis-stimulating agents, in patients who do not require IV iron

Common IV iron preparations include iron sucrose (100-200 mg per session), ferric gluconate (125 mg per session), or ferric carboxymaltose (500-1000 mg per dose) 1. These medications should be administered slowly to minimize adverse reactions. For maintenance therapy, 100-200 mg of IV iron every 2-4 weeks is typically sufficient. IV iron is preferred over oral iron in hemodialysis patients because of poor oral absorption due to hepcidin upregulation, which blocks intestinal iron absorption 1.

It is essential to weigh the benefits and risks of IV iron administration in hemodialysis patients, taking into account the potential for iron overload and its associated morbidity and mortality. By using IV iron judiciously and monitoring iron status regularly, clinicians can help minimize the risks associated with IV iron administration and optimize patient outcomes.

From the FDA Drug Label

Ferrlecit administration was identical to Study A The primary efficacy variable was the change in hemoglobin from baseline to the last available observation through Day 50. In this patient population, only the Ferrlecit-treated group achieved increase in hemoglobin and hematocrit from baseline Table 2: Study B: Hemoglobin, Hematocrit, and Iron Studies Mean Change from Baseline to One Month after Treatment Ferrlecit (N=38)ChangeOral Iron (N=25)Change Hemoglobin (g/dL)1.30.4 Hematocrit (%)3.80.2 Transferrin Saturation (%)6.71. 7 Serum Ferritin (ng/dL)73-145 Study C was a multicenter, randomized, open-label study of the safety and efficacy of two Ferrlecit dose regimens (1.5 mg/kg or 3. 0 mg/kg of elemental iron) administered intravenously to 66 iron-deficient (transferrin saturation <20% and/or serum ferritin <100 ng/mL) pediatric hemodialysis patients, The primary endpoint was the change in hemoglobin concentration from baseline to 2 weeks after last Ferrlecit administration.

Intravenous Iron and Hemodialysis:

• The use of intravenous iron, such as Ferrlecit, is supported in hemodialysis patients to increase hemoglobin and hematocrit levels.
• Studies have shown that Ferrlecit administration can achieve significant increases in hemoglobin and hematocrit from baseline in iron-deficient hemodialysis patients 2.
• The recommended dosing regimens for Ferrlecit in hemodialysis patients vary, but typical doses range from 1.5 mg/kg to 3.0 mg/kg of elemental iron, administered intravenously during sequential dialysis sessions 2.
• It is essential to monitor patients' iron status, hemoglobin, and hematocrit levels during treatment with intravenous iron to ensure safe and effective use 2.

From the Research

IV Iron Administration in Hemodialysis Patients

• IV iron is a standard treatment for patients undergoing hemodialysis, and its administration has been shown to improve anemia parameters 3.
• A study comparing proactive, high-dose IV iron supplementation with reactive, low-dose IV iron supplementation found that the high-dose regimen was superior in reducing the risk of nonfatal myocardial infarction, nonfatal stroke, hospitalization for heart failure, or death 4.
• Another study found that IV ferric carboxymaltose administration was more effective and better tolerated than sodium ferric gluconate for iron deficiency correction and resolution of anemia in hemodialysis patients 5.

Comparison of Iron Dosing Strategies

• A randomized controlled trial compared the efficacy of two iron dosing strategies in patients undergoing long-term hemodialysis, and found that a less frequent but higher single dose of ferric carboxymaltose did not meet noninferiority for maintaining hemoglobin levels compared with iron sucrose administered more frequently 6.
• A meta-analysis of studies on IV iron therapy in hemodialysis patients with functional iron deficiency anemia found that IV iron therapy resulted in significant increases in hemoglobin, serum ferritin, and transferrin saturation rate, as well as a significant decrease in erythropoietin dose 3.

Safety and Efficacy of IV Iron Therapy

• The safety and efficacy of IV iron therapy in hemodialysis patients have been evaluated in several studies, and the results suggest that IV iron therapy is generally well-tolerated and effective in improving anemia parameters 5, 3, 4.
• However, one study found that IV iron therapy was associated with an increased risk of infections, although this finding was not consistent across all studies 6, 4.