Intravenous iron replacement with sodium ferric gluconate complex in sucrose for iron deficiency anemia in adults.

BACKGROUND

When oral iron replacement therapy is ineffective, IV or IM iron dextran products have been used successfully in many patients. However, adverse events, including urticaria, anaphylaxis, and death, sometimes are associated with the use of these products.

OBJECTIVE

The aim of this study was to assess the efficacy and tolerability of sodium ferric gluconate complex (SFGC) in sucrose in the treatment of adults with iron deficiency anemia.

METHODS

This was a single-center, open-label, uncontrolled study. Consecutive adults in need of IV iron replacement who experienced severe reactions to generic IV iron dextran and who had previously failed to respond to oral iron products were treated with a single dose of IV SFGC (312, 375, or 500 mg) infused over 2 hours. A second dose of SFGC could be administered 6 to 8 weeks later, if needed.

RESULTS

Six patients (3 men, 3 women; mean [SD] age, 77.0 [10.4] years) were enrolled. All patients received a single-dose infusion of SFGC, and 2 patients received a second dose. No adverse events were observed at the lower doses (312 and 375 mg); however, both patients given the 500-mg dose reported transient nausea, and 1 had pruritus and the other had transient hypertension.

CONCLUSIONS

The results of this study show that SFGC is a satisfactory alternative when IV iron replacement is needed by adults with iron deficiency anemia.