Efficacy and Tolerability of Intravenous Ferric Sodium Gluconate in the Treatment of Iron Deficiency Anemia in Non-Kidney Disease Patients.

Abstract Background: Standard of care suggests that patients with iron deficiency anemia requiring iron replacement should be treated with oral ferrous sulfate or ferrous gluconate. However, many patients cannot tolerate or are unable to absorb these oral iron preparations, especially, for the several months necessary to replete iron stores. This intolerance is primarily due to significant gastrointestinal side effects. Ferric dextran is FDA approved for parenteral treatment of iron deficiency anemia and is the drug most commonly used for treatment of adults. While, iron dextran is generally safe and effective, this drug still has a significant side effect profile, including generalized body aches, arthralgias, myalgias, nausea, vomiting, anaphylaxis, and death. Intravenous (IV) ferric sodium gluconate (Ferrlecit) is FDA approved for the treatment of iron deficiency anemia associated with hemodialysis due to chronic kidney disease but is not approved for treatment of other causes of iron deficiency anemia. IV ferric sodium gluconate is efficacious and very well tolerated, with minimal side effects in treated patients. We report a retrospective review of the NMCSD experience in the treatment of iron deficiency anemia with intravenous ferric sodium gluconate in patients without kidney disease. Methods: From January 2002 to July 2005, 59 consecutive adult non-hemodialysis patients who received Ferrlecit were identified. Inclusion criteria were patients with suspected iron deficiency who did not have a diagnosis of chronic kidney or end stage renal disease. At present, 34 patients receiving 256 infusions of ferric sodium gluconate have had their chart and laboratory reviews completed and are the subject of this analysis. Efficacy of treatment was measured with pre- and post-treatment hemoglobin, hematocrit, mean corpuscular volume, and ferritin. All uses of premedication as well as adverse events were recorded. Results: Of the 256 infusions, 5 infusion reactions were documented. None of these were classified as “severe” or “anaphylactic” requiring discontinuation. No medications were needed for intervention, and most reactions responded to slowing of the infusion or premedication on subsequent doses. Only 3 patients required benadryl for premedication on a total of 4 occasions. All efficacy end points showed improvement in those parameters measured. Table 1: . Pre and Post Treatment Incremental Increases in Hematologic Variables N=31 Median Increase 95% Confidence Interval P-value Hemoglobin (g/dl) 2.9 1.34 to 4.43 Hematocrit (%) 7.7 3.75 to 11.42 MCV (fl ) 10.0 3.58 to 14.49 Ferritin (ng/ml) 73.9 40.52 to 105.95 Conclusions: We conclude that IV ferric sodium gluconate is safe and efficacious and lacks the significant side effect profile demonstrated by patients exposed to iron dextran. We suggest the use of IV ferric sodium gluconate as the new standard of care for intravenous iron replacement in non-hemodialysis patients with anemia requiring a parenteral form of iron replacement. Updated information on all 59 patients to include clinical characteristics will be reported at a later date. This is the largest published study of the use of IV ferric sodium gluconate in non-dialysis iron deficient patients.