Table 2.

Intravenous iron formulations with FDA-approved indications in children

FormulationApproved pediatric indicationApproved dosing and administration notes*
Iron dextran Children over 4 months of age Dose (mL)  =  0.0442 (Desired Hgb – Observed Hgb)  ×  LBW + (0.26  ×  LBW)
Requires test dose prior to full therapeutic dose 
Iron sucrose Iron maintenance in patients ≥2 years with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy Dose  =  0.5  mg/kg, not to exceed 100  mg per dose every 2 weeks (for hemodialysis-dependent patients) or 4 weeks (for non-dialysis-dependent patients on erythropoietin therapy) for 12 weeks 
Ferric gluconate Treatment of IDA in pediatric patients ≥6 years undergoing chronic hemodialysis receiving erythropoietin therapy Dose  =  0.12   mL/kg (1.5  mg/kg of elemental iron) administered intravenously over 1 hour during 8 sequential dialysis sessions (maximum 125  mg per dose) 
Ferric carboxymaltose Treatment of children aged >1 year with IDA who are intolerant of oral iron or who have unsatisfactory response to oral iron Patients <50  kg: 15  mg/kg/dose for 2 doses
Patients ≥50  kg: 750  mg/dose for 2 doses
Separate doses by at least 7 days
Alternative dose is 15  mg/kg (maximum 1000  mg) as single infusion
Associated with hypophosphatemia 
FormulationApproved pediatric indicationApproved dosing and administration notes*
Iron dextran Children over 4 months of age Dose (mL)  =  0.0442 (Desired Hgb – Observed Hgb)  ×  LBW + (0.26  ×  LBW)
Requires test dose prior to full therapeutic dose 
Iron sucrose Iron maintenance in patients ≥2 years with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy Dose  =  0.5  mg/kg, not to exceed 100  mg per dose every 2 weeks (for hemodialysis-dependent patients) or 4 weeks (for non-dialysis-dependent patients on erythropoietin therapy) for 12 weeks 
Ferric gluconate Treatment of IDA in pediatric patients ≥6 years undergoing chronic hemodialysis receiving erythropoietin therapy Dose  =  0.12   mL/kg (1.5  mg/kg of elemental iron) administered intravenously over 1 hour during 8 sequential dialysis sessions (maximum 125  mg per dose) 
Ferric carboxymaltose Treatment of children aged >1 year with IDA who are intolerant of oral iron or who have unsatisfactory response to oral iron Patients <50  kg: 15  mg/kg/dose for 2 doses
Patients ≥50  kg: 750  mg/dose for 2 doses
Separate doses by at least 7 days
Alternative dose is 15  mg/kg (maximum 1000  mg) as single infusion
Associated with hypophosphatemia 
*

See product package insert for additional administration and dosing guidelines.

Large intravenous doses associated with delayed reactions: arthralgias, fever, nausea, and chills 24 to 48 hours after administration.

Hgb, hemoglobin; LBW, lean body weight.

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