Intravenous Iron Sucrose for Children with Iron Deficiency and/or Gastrointestinal Hemorrhage.

For decades parenteral iron has been used in patients with iron deficiency unresponsive to oral iron therapy and in hemodialysis-dependent patients receiving erythropoietin therapy. Iron dextran, used extensively in the past, is associated with a high rate of serious anaphylactic reactions and thus its use in children has been very limited. Intravenous (IV) iron sucrose (Venofer®) was approved by the FDA in 2000 for patients with chronic renal disease receiving erythropoietin therapy. Its safety profile being much more favorable than that of iron dextran, it has generally replaced iron dextran for use in both adults and children with chronic kidney disease. However, the use of iron sucrose for other indications in children has not to our knowledge been widely reported. Therefore, we sought to review our institution's quite favorable experience with IV iron sucrose in children without chronic renal disease.

Pharmacy records were reviewed on all children (≤ 18 yrs of age) who received IV iron sucrose at Children's Medical Center Dallas between January 1, 2004 and June 30, 2009. Patients who received iron sucrose for chronic renal disease were excluded from analysis, and complete medical records were reviewed for patients receiving iron sucrose for all other indications. Data abstracted included primary indication for iron sucrose, underlying diagnoses, prior iron therapy, laboratory values before and after therapy, and adverse reactions.

157 children received at least one dose of IV iron sucrose during this period. 116 patients with chronic kidney disease were excluded as well as 3 patients with insufficient medical records. The remaining 38 patients who received iron sucrose for other indications were analyzed. Thirteen patients received IV iron sucrose due to iron deficiency refractory to oral iron therapy, 13 for primary iron malabsorption or dependence on parenteral nutrition, 7 for chronic gastrointestinal blood loss, and 5 for miscellaneous indications. The table shows the response in each group to both oral iron preparations and IV iron sucrose.

The age of patients when they received IV iron sucrose ranged from 3 months to 18 yrs (median 5 yrs). The number of doses ranged from 1 to 255 (mean 13, median 3). The individual doses of IV iron sucrose ranged from 25mg to 500mg (median 100mg). All doses were diluted in a maximum of 250mL of normal saline and given over 15 minutes to 3.5 hours, depending on the dose and patient weight. The wide variety of doses and schedules employed reflected physician choice and lack of clear guidelines in the package insert. In the 38 children, who received a total of 510 doses of iron sucrose, there were only 6 adverse reactions attributed to the infusions. Five were mild (including headache, stomach irritation, transient mild hypotension and vasovagal reaction). One serious reaction occurred in an adolescent who received a large dose of 500 mg iron sucrose diluted in 250mL of normal saline over 35 minutes. The patient developed anxiety, face swelling, thready pulse, and hypotension. She promptly recovered following epinephrine, diphenyhydramine and methylprednisolone.

IV iron sucrose is a safe and effective means to treat iron deficiency in children who 1) do not respond to oral iron due to intolerance or poor compliance, 2) cannot absorb oral iron due to a variety of congenital or acquired gastrointestinal disorders, and 3) who have ongoing blood loss making oral supplementation ineffective. An oral iron absorption test might help determine which patients are candidates for iron sucrose or another intravenous iron preparation. Prospective study of IV iron sucrose using standardized dosage guidelines are indicated in children and adults to confirm and extend these results.

Off Label Use:Iron Sucrose for iron deficiency in children.