Can a 13-Year-Old Weighing 56 kg Receive IV Monoferric?
No, a 13-year-old patient weighing 56 kg should not receive IV Monoferric (ferric derisomaltose) as it is not FDA-approved for pediatric use, and there is insufficient safety and efficacy data in this age group.
FDA Approval Status and Age Restrictions
- Monoferric lacks FDA approval for pediatric patients under 18 years of age 1, 2.
- The FDA-approved maximum single dose for adults is 1000 mg administered over 20 minutes for doses ≤1000 mg 3.
- Unlike ferric carboxymaltose (which recently gained FDA approval for children ≥1 year), ferric derisomaltose has not undergone pediatric clinical trials or received pediatric approval 4.
Alternative IV Iron Options for Pediatric Patients
If IV iron is clinically necessary for this 13-year-old, consider FDA-approved pediatric formulations:
Iron Dextran (Low Molecular Weight)
- Approved for pediatric use with weight-based dosing 3.
- For a patient weighing 56 kg (>20 kg), the recommended dose is 500 mg diluted in 250 mL saline, infused over appropriate duration 3.
- Requires test dose due to anaphylaxis risk, though serious reactions are rare with low molecular weight formulations 3.
Ferric Carboxymaltose
- Recently FDA-approved for children ≥1 year 4.
- Retrospective studies demonstrate effectiveness and tolerability in pediatric populations with various underlying conditions 4.
- Maximum dose of 750 mg (FDA) or 1000 mg (EMA) per administration 3.
Iron Sucrose or Sodium Ferric Gluconate
- Long-standing use in pediatric populations, particularly in chronic kidney disease 3.
- Smaller doses (62.5-125 mg) administered more frequently reduce risk of adverse effects 3.
- Iron sucrose: maximum 200 mg per dose, 500 mg per week 3.
Clinical Decision Framework
Before proceeding with any IV iron:
- Confirm iron deficiency with ferritin <100 ng/mL or ferritin 100-300 ng/mL with transferrin saturation <20% 3.
- Evaluate for oral iron failure - intolerance, inadequate response, or malabsorption 1.
- Assess hemoglobin level - IV iron most beneficial when Hb <10 g/dL 1.
- Screen for contraindications - active infection, hypersensitivity history, iron overload 3, 1.
Safety Considerations Specific to Pediatrics
- Hypersensitivity reactions occur in <1% but require resuscitation facilities available 5, 6.
- Hypophosphatemia risk varies by formulation - ferric carboxymaltose carries higher risk than ferric derisomaltose in adults, but pediatric data are limited 5.
- Patients with comorbidities have 3.6 times higher risk of hypersensitivity reactions regardless of iron formulation 7.
Monitoring After IV Iron Administration
- Recheck iron parameters 8-10 weeks post-infusion, not earlier, as ferritin is falsely elevated immediately after IV iron 3.
- Monitor hemoglobin and red cell indices at 3-month intervals for the first year after repletion 1.
Common Pitfall to Avoid
Do not administer IV iron based solely on anemia without confirming iron deficiency - ferritin >500 ng/mL without low transferrin saturation suggests anemia of chronic disease rather than iron deficiency, and IV iron supplementation is potentially harmful in iron-replete states 3.