Intravenous iron sucrose for children with iron deficiency failing to respond to oral iron therapy

Abstract

Background For decades, parenteral iron has been used in patients with iron deficiency unresponsive to oral iron therapy and in hemodialysis‐dependent patients receiving erythropoietin. Newer intravenous (IV) iron formulations such as iron sucrose have replaced high‐molecular weight iron (HMW) dextran in dialysis patients; however, the use of parenteral iron in children without renal disease has not been well defined. Procedure Pharmacy records were reviewed on children (≤18 years 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. Results Thirty‐eight children received iron sucrose for non‐renal indications, 13 with iron deficiency refractory to oral iron therapy, 13 with iron malabsorption or dependence on parenteral nutrition, 7 for chronic gastrointestinal blood loss, and 5 for miscellaneous indications. Among these 38 children, who received a total of 510 doses of IV iron sucrose, there were only six adverse reactions. Patients in all categories had a good response to the iron sucrose, with a median hemoglobin rise of 1.9–3.1 g/dl depending on the indication. Conclusions Parenteral iron is a safe and effective means to treat iron deficiency in children who cannot receive or do not respond to oral iron due to intolerance, poor adherence, or iron malabsorption. Pediatr Blood Cancer 2011;56:615–619. © 2010 Wiley‐Liss, Inc.

Intravenous iron sucrose for children with iron deficiency anemia: a single institution study

“…[6] The experience with IV iron sucrose for the treatment of IDA in children is very limited, and all manufacturers do not recommend its use in children due to lack of adequate pediatric data. [7][8][9] We describe herein our department's experience with the use of IV iron sucrose in children with IDA that were intolerant, non-compliant or failed to respond to oral iron therapy.…”

Iron sucrose – characteristics, efficacy and regulatory aspects of an established treatment of iron deficiency and iron-deficiency anemia in a broad range of therapeutic areas

“…In pediatric non-CKD patients (3 months to 18 years) who received 510 IS administrations (25 --500 mg iron), individual IS doses < 3 mg iron/kg body weight were well tolerated without drug-related adverse events [77]. Five mild events were observed with individual doses of 3.0 --5.1 mg iron/kg, and only one serious-related adverse event (body aches, facial swelling, thready pulse and hypotension) was reported after an individual 500 mg iron dose that was given within 35 min (i.e., 200 mg above the recommended dose corresponding to an individual dose of 8.8 mg/kg).…”

“…One retrospective study in pediatric non-CKD patients aged 3 months to 18 years who were treated with IS with individual doses of 25 --500 mg iron revealed significant improvements in Hb levels compared to oral iron in children who were refractory to oral iron or had malabsorption (+3.1 vs +0.05 g/dl; p < 0.001 and +1.9 vs +0.4 g/dl; p = 0.04, respectively) [77].…”

“…Crary et al [77] Treated with IS for any non-CKD condition IS: 38 25--500 mg Five mild, related AEs (abdominal pain 2, headache 1, transient hypotension 1, vasovagal syncope 1) with IS at 3.0--5.1 mg/kg, 1 SAE (body aches, facial swelling, thready pulse, hypotension) with IS at 8.8 mg/kg *At study sites in Mexico, prevalence of severe anemia was so high that patients with lower Hb and no prior ESA use were allowed to enroll. ferritin up to 1200 ng/ml) showed no increase in the incidence of culture positive bacteremias, pneumonias, soft tissue infections or osteomyelitis over a 1-year period [96].…”

“…iron products). Among the 36 published clinical studies [45][46][47][48][49][50][55][56][57][58][59][60]64,65,70,74,[76][77][78][79][80][81][82][83][84][85][86][87][88][89][90][91] that are included in the clinical dossier of Venofer, 26 reported at least some details about adverse drug events; 3 of those reported at least possibly related serious adverse events (all nonfatal, Table 2) [51,76,77]. Three reports included only general statements on safety without further details (e.g., no serious adverse reactions were noted) [47,48,64].…”