What is the lower age limit for Ferinject (ferric carboxymaltose)?

Lower Age Limit for Ferric Carboxymaltose (Ferinject)

Ferric carboxymaltose (Ferinject) has not been studied in children and is not recommended for use in children under 14 years of age. 1

Age Restrictions and Evidence Base

• Ferric carboxymaltose has been extensively studied in adult populations with iron deficiency anemia of various etiologies, but clinical trials have not included pediatric populations under 14 years 2
• According to European guidelines, "The use of ferric carboxymaltose has not been studied in children, and therefore is not recommended in children under 14 years" 1
• This age restriction is explicitly stated in the Summary of Product Characteristics for Ferinject 1

Clinical Considerations for Iron Replacement in Different Age Groups

• For adult patients (≥14 years), ferric carboxymaltose offers significant advantages including:

  • Ability to administer high single doses (up to 1000 mg) in a short time (15 minutes) 2, 3
  • Fewer required infusions compared to other IV iron formulations 4
  • No test dose requirement, unlike iron dextran preparations 4

• For patients with iron deficiency requiring IV iron therapy:

  • Weight-based dosing is recommended for determining total iron needs 1
  • Dosing tables are available that consider both hemoglobin level and patient weight 1

Safety Profile and Considerations

• Ferric carboxymaltose is generally well-tolerated with most adverse events being mild to moderate 3
• Common side effects include headache, dizziness, nausea, abdominal pain, constipation, diarrhea, rash, and injection-site reactions 3
• Contraindications include hypersensitivity to the active substance, evidence of iron overload, or hemoglobin levels >15 g/dL 1

Alternative Options for Pediatric Patients

• For children under 14 years with iron deficiency anemia, oral iron supplementation remains the first-line therapy 1
• When oral iron is ineffective or not tolerated in pediatric patients, other IV iron formulations with established pediatric dosing may need to be considered 1

Clinical Application

• Always verify patient age before prescribing ferric carboxymaltose
• For adolescents ≥14 years and adults, ferric carboxymaltose can be administered according to the approved dosing schedule 1
• For children <14 years, alternative iron replacement strategies should be pursued 1

The age restriction is an important safety consideration as the pharmacokinetics, efficacy, and safety profile of ferric carboxymaltose have not been established in younger pediatric populations.