Injectafer (Ferric Carboxymaltose) Dosing for Pediatric Patients
Injectafer is not approved for use in children under 1 year of age. For children 1 year and older with iron deficiency anemia, the recommended dose is 15 mg/kg body weight up to a maximum single dose of 750 mg, administered intravenously.
Dosing Guidelines by Age
Children under 1 year
- Not recommended due to insufficient safety and efficacy data
Children 1 year and older
- Dose: 15 mg/kg body weight per dose
- Maximum single dose: 750 mg
- Administration: Intravenous infusion over 15 minutes
- Frequency: May be repeated after 7 days if needed to achieve total iron replacement dose
Administration Considerations
- Route: Intravenous only
- Administration time: ≤15 minutes per dose
- No test dose required: Unlike older iron formulations, no test dose is needed 1
- Monitoring: Observe patients for signs of hypersensitivity during and after administration
Clinical Evidence
Ferric carboxymaltose (Injectafer) has been studied in pediatric populations with various conditions causing iron deficiency anemia. The evidence indicates it is effective and generally well-tolerated in children over 1 year of age 1.
A review of available clinical data shows that:
- Improvements in hemoglobin levels and iron status parameters were reported in 26 of 27 publications that included efficacy data 1
- Safety profile in children is consistent with that observed in adults 1
- Ferric carboxymaltose allows for controlled delivery of iron to target tissues 2
Advantages Over Oral Iron
- Rapid correction of iron deficiency anemia
- Fewer administrations needed compared to other IV iron formulations
- Better gastrointestinal tolerability compared to oral iron supplements
- More effective in replenishing iron stores 3
- Can be used when oral iron is ineffective or cannot be administered 2
Monitoring Recommendations
- Check hemoglobin, ferritin, and transferrin saturation before treatment and 2-4 weeks after administration
- Monitor for hypersensitivity reactions during and after administration
- Assess for hypophosphatemia, which has been reported with ferric carboxymaltose use
Important Considerations and Precautions
- Iron status monitoring: Regular monitoring of iron status (at least ferritin and hemoglobin) is essential to prevent both iron deficiency and iron overload 4
- Alternative options: If available and tolerated, enteral iron supplementation is preferred over parenteral administration for patients receiving parenteral nutrition 4
- Contraindications: Hypersensitivity to ferric carboxymaltose or any components of the formulation
Common Side Effects
- Headache
- Dizziness
- Nausea
- Injection site reactions
- Transient hypophosphatemia
While there are limited prospective randomized controlled trials in pediatric populations, the available evidence supports the efficacy and safety of Injectafer in children over 1 year of age with iron deficiency anemia 1, 2.