What is the initial dose of iron sucrose (iron sucrose) for pediatric patients?

Initial Dosing of Iron Sucrose for Pediatric Patients

For pediatric patients 2 years of age and older, the initial dose of iron sucrose is 0.5 mg/kg, not to exceed 100 mg per dose. 1

Dosing Guidelines by Clinical Scenario

Pediatric Patients with Hemodialysis-Dependent CKD (HDD-CKD)

• For iron maintenance treatment: 0.5 mg/kg (maximum 100 mg per dose) every two weeks for 12 weeks 1
• Administration options:
  • Undiluted by slow intravenous injection over 5 minutes
  • Diluted in 0.9% NaCl at a concentration of 1-2 mg/mL administered over 5-60 minutes 1
• Do not dilute to concentrations below 1 mg/mL 1

Pediatric Patients with Non-Dialysis Dependent CKD (NDD-CKD) or Peritoneal Dialysis Dependent CKD (PDD-CKD)

• For iron maintenance treatment: 0.5 mg/kg (maximum 100 mg per dose) every four weeks for 12 weeks 1
• Administration follows the same guidelines as for HDD-CKD patients 1
• The American Academy of Pediatrics recommends iron sucrose for children with CKD from 2 years of age 2

Safety Considerations

• Iron sucrose is preferred for pediatric use due to its low risk of severe adverse events 2
• No test dose is required, unlike iron dextran 2
• Important safety considerations:
  • Systemic iron toxicity with hepatocellular damage has been reported in pediatric patients receiving excessive doses 2
  • Only administer intravenously by slow injection or infusion 1
  • Each mL contains 20 mg of elemental iron 1

Clinical Evidence Supporting Use

• Studies have demonstrated that iron sucrose at 0.5 mg/kg at prescribed intervals is noninferior to higher doses in maintaining hemoglobin levels >10.5 g/dL in children receiving erythropoiesis-stimulating agent therapy 3
• Research shows that IV iron sucrose is safe and effective in children with iron deficiency anemia who do not respond to or cannot tolerate oral iron therapy 4, 5
• Common adverse effects are minimal, with injection site disorders and transient taste perversion being the most frequently reported 4

Important Considerations

• Enteral iron supplementation is preferred over parenteral iron when possible 2
• Regular monitoring of iron status is essential to prevent both iron deficiency and iron overload 2
• Higher doses (3 mg/kg/dialysis) have been associated with possible iron overload in children on hemodialysis 6
• Dosing for iron replacement treatment (as opposed to maintenance) in pediatric patients with HDD-CKD, NDD-CKD, or PDD-CKD has not been established in FDA labeling 1