Brand Name: Ferrlecit
Active Ingredient: sodium ferric gluconate complex sucrose injection
Indication: iron deficiency in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy
Company Name: Schein Pharmaceutical, Inc.
Introduction
Ferrlecit is used to increase the total body content of iron in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. Iron is crucial for normal hemoglobin synthesis and an important component of DNA metabolism and synthesis and many enzymatic processes. Erythropoietin therapy increases the production of red blood cells and iron utilization. This increase in iron utilization can cause iron deficiency in hemodialysis patients.
Ferrlecit: Clinical Study Results
Two studies were conducted to determine the safety and efficacy of Ferrlecit in patients undergoing hemodialysis and on erythropoietin therapy. The first study was multicenter, randomized, and open-label in design and included an historical control group. Patients initially received 25 mg Ferrlecit and were then randomized to receive either 62.5 mg of Ferrlecit over 30 minutes (n = 39) or 125 mg of Ferrlecit over 60 minutes (n = 44). Eight doses were administered during sequential dialysis sessions. The primary endpoint was a change in hemoglobin from baseline to the last available observation through day 40. Patients in the high-dose Ferrlecit group demonstrated the greatest increases in hemoglobin (1.1 g/dl) and hematocrit (3.6%) over baseline (p-value vs. 500 mg group and the historical control group < 0.01). The results were similar between the low-dose group and the oral iron group for changes in hemoglobin and hematocrit levels, 0.3 g/dl vs. 0.4 g/dl and 1.4% vs. 0.8%, respectively.
A single-center, non-randomized, open-label, historically-controlled study was also carried out. Ferrlecit administration was the same as the above study. Again, Ferrlecit proved to be more effective than oral iron administration. Patients in the Ferrlecit group experienced a significant (p < 0.001 from baseline by the paired t-test method) increase in hemoglobin (1.3 g/dl) and hematocrit (3.8%) levels over the control group (0.4 g/dl; 0.8%).
What the Patient Should Know
Some possible adverse events associated with use of Ferrlecit are headache, abdominal pain, fatigue, and fever.
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