What is the recommended Venofer (iron sucrose) regimen for treating adolescent anemia?

Venofer (Iron Sucrose) Regimen for Adolescent Anemia

For adolescents with iron deficiency anemia, the recommended Venofer (iron sucrose) regimen is 0.5 mg/kg (not to exceed 100 mg per dose) administered intravenously every two weeks for 12 weeks for hemodialysis-dependent patients or every four weeks for 12 weeks for non-dialysis dependent patients. 1

Dosing Guidelines for Adolescents

Approved Indications

• Iron sucrose is FDA-approved for use in children 2 years of age and older 1
• Primarily indicated for iron maintenance treatment in:
  • Hemodialysis-dependent chronic kidney disease (HDD-CKD)
  • Non-dialysis dependent chronic kidney disease (NDD-CKD)
  • Peritoneal dialysis-dependent chronic kidney disease (PDD-CKD) patients on erythropoietin therapy

Specific Dosing Recommendations

1. For HDD-CKD adolescents (maintenance treatment):

   • 0.5 mg/kg, not exceeding 100 mg per dose
   • Administered every two weeks for 12 weeks 1

2. For NDD-CKD or PDD-CKD adolescents on erythropoietin therapy (maintenance treatment):

   • 0.5 mg/kg, not exceeding 100 mg per dose
   • Administered every four weeks for 12 weeks 1

Administration Methods

Iron sucrose can be administered in two ways:

1. Undiluted: Given as slow intravenous injection over 5 minutes
2. Diluted: In 0.9% NaCl at a concentration of 1-2 mg/mL and administered over 5-60 minutes

Important notes:

• Do not dilute to concentrations below 1 mg/mL 1
• The FDA label specifically states that Venofer treatment may be repeated if necessary 1

Safety Considerations

Iron sucrose has a favorable safety profile compared to other IV iron preparations:

• No test dose is required (unlike iron dextran) 2
• Severe adverse reactions are rare in children 3
• In pediatric studies, 232 children received 1624 doses of iron sucrose with very few serious adverse reactions 3

Potential Adverse Effects

• Monitor for potential adverse effects including:
  • Dyspnea, wheezing, hypotension
  • Nausea, vomiting, abdominal pain
  • Arthralgia and myalgia 3

Caution

• A case of systemic iron toxicity with hepatocellular damage was reported in a pediatric patient receiving 16 mg/kg of iron sucrose (exceeding recommended dose) 3
• The maximum recommended single dose should not exceed 100 mg in pediatric patients 1

Monitoring Recommendations

• Monitor iron status (at least ferritin and hemoglobin) regularly to prevent iron deficiency and iron overload 3
• After initiating therapy, monitor hemoglobin levels every 4 weeks until normalization 2
• Once hemoglobin normalizes, check complete blood count at 3-month intervals for 12 months 2

Clinical Considerations

• Iron sucrose is the most studied iron preparation in children, with severe adverse events being rare 3
• While the FDA has approved dosing for iron maintenance treatment in adolescents, the dosing for iron replacement treatment in pediatric patients with various forms of CKD has not been established 1
• When possible, iron supplementation should preferentially be given enterally rather than parenterally if tolerated 3

Iron sucrose provides an effective and well-tolerated treatment option for adolescents with iron deficiency anemia, particularly those with chronic conditions or when oral iron preparations are ineffective or not tolerated 4.