General Information

Ferrlecit (sodium ferric gluconate complex in sucrose injection) is used to replete the total body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and synthesis of DNA and various enzymatic processes.

Ferrlecit is specifically indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.

Ferrlecit is supplied as an injection for intravenous use. The recommended dosing is as follows:

Adult Patients

• The recommended adult dosage is 10 mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session or undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session.

Pediatric Patients

• The recommended pediatric dosage is 0.12 mL/kg (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. 

Do not mix Ferrlecit with other medications or add to parenteral nutrition solutions for intravenous infusion. Administer in 0.9% saline

Mechanism of Action

Ferrlecit is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and various enzymatic processes.

Side Effects

Adverse effects associated with the use of Ferrlecit may include, but are not limited to the following:

Adults:

• nausea
• vomiting and/or diarrhea
• injection site reaction
• hypotension
• cramps
• hypertension
• dizziness
• dyspnea
• chest pain
• leg cramps
• pain

Patients 6 to 15 years of age:

• hypotension
• headache
• hypertension
• tachycardia
• vomiting

Clinical Trial Results

Study A was a three-center, randomized, open-label study of the safety and efficacy of two doses of Ferrlecit administered intravenously to iron-deficient hemodialysis patients. The study included both a dose-response concurrent control and an historical control. Enrolled patients received a test dose of Ferrlecit (25 mg of elemental iron) and were then randomly assigned to receive Ferrlecit at cumulative doses of either 500mg (low dose) or 1000mg (high dose) of elemental iron. Ferrlecit was given to both dose groups in eight divided doses during sequential dialysis sessions (a period of 16 to 17 days). At each dialysis session, patients in the low-dose group received Ferrlecit 62.5 mg of elemental iron over 30 minutes, and those in the high-dose group received Ferrlecit 125mg of elemental iron over 60 minutes. The primary endpoint was the change in hemoglobin from baseline to the last available observation through Day 40.

Eligibility for this study included chronic hemodialysis patients with a hemoglobin below 10 g/dl (or hematocrit at or below 30%) and either serum ferritin below 200 ng/ml or iron saturation below 18%. Exclusion criteria included significant underlying disease or inflammatory conditions or an erythropoietin (EPO) requirement of greater than 10,000 units three times per week. Parenteral iron and red cell transfusion were not allowed for two months before the study. Oral iron and red cell transfusion were not allowed during the study for Ferrlecit-treated patients.

The historical control population consisted of 25 chronic hemodialysis patients who received only oral iron supplementation for 14 months and did not receive red cell transfusion. All patients had stable EPO doses and hematocrit values for at least two months before initiation of oral iron therapy.

The evaluated population consisted of 39 patients in the low-dose Ferrlecit group, 44 patients in the high-dose Ferrlecit group, and 25 historical control patients.

The mean baseline hemoglobin and hematocrit were similar between treatment and historical control patients: 9.8 g/dl and 29% and 9.6 g/dl and 29% in low- and high-dose Ferrlecit treated patients, respectively, and 9.4 g/dl and 29% in historical control patients. Baseline serum iron saturation was 20% in the low-dose group, 16% in the high-dose group, and 14% in the historical control. Baseline serum ferritin was 106 ng/ml in the low-dose group, 88 ng/ml in the high-dose group, and 606 ng/ml in the historical control. Patients in the high-dose Ferrlecit group achieved significantly higher increases in hemoglobin and hematocrit than either patients in the low-dose Ferrlecit group or patients in the historical control group (oral iron). Patients in the low-dose Ferrlecit group did not achieve significantly higher increases in hemoglobin and hematocrit than patients receiving oral iron.