What is the use of Ferric carboxymaltose (Intravenous Iron) in pediatric patients?

From the Guidelines

Ferric carboxymaltose (FCM) can be used in pediatric patients with iron deficiency anemia, but its use is not approved in Europe and should be considered on a case-by-case basis, taking into account the potential risks and benefits, as well as the availability of other intravenous iron formulations, such as iron sucrose, which has a stronger evidence base in pediatric patients 1.

Key Considerations

• The use of FCM in pediatric patients is not approved in Europe, and its safety and efficacy in this population have not been extensively studied 1.
• Iron sucrose is the most studied intravenous iron formulation in children and is approved in the USA for use in children from 2 years of age, making it a preferred option for pediatric patients 1.
• The recommended dosing for FCM in children is not well established, but a dose of 15 mg/kg up to a maximum single dose of 750 mg has been suggested, with a maximum cumulative dose of 1500 mg 1.
• Common side effects of FCM include transient hypophosphatemia, headache, nausea, and injection site reactions, and hypersensitivity reactions are rare but can occur 1.

Monitoring and Precautions

• Laboratory monitoring should include complete blood count, iron studies, and phosphate levels before treatment and 2-4 weeks after administration 1.
• Healthcare providers should be prepared to manage hypersensitivity reactions and other potential adverse events associated with FCM administration 1.
• FCM should not be used in patients with known hypersensitivity to the product or during the first trimester of pregnancy, unless the benefits outweigh the risks 1.

Alternative Options

• Iron sucrose is a viable alternative to FCM for pediatric patients, with a stronger evidence base and approval in the USA for use in children from 2 years of age 1.
• Other intravenous iron formulations, such as iron gluconate, may also be considered, but their safety and efficacy in pediatric patients have not been extensively studied 1.

From the FDA Drug Label

The safety and effectiveness of Injectafer for IDA in pediatric patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron have been established Use of Injectafer for this indication in this age group is supported by evidence from adequate and well-controlled studies of Injectafer in adults with additional pharmacodynamic and safety data in pediatric patients aged 1 year and older Safety and effectiveness of Injectafer have not been established in pediatric patients less than 1 year of age with IDA. Safety and effectiveness of Injectafer have not been established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure.

The use of Ferric carboxymaltose (Intravenous Iron) in pediatric patients is for the treatment of iron deficiency anemia (IDA) in patients aged 1 year and older who have normal kidney function and have either intolerance to oral iron or have had unsatisfactory response to oral iron 2.

• The safety and effectiveness have been established in this age group.
• It is not established for use in pediatric patients less than 1 year of age with IDA.
• It is not established to improve exercise capacity in pediatric patients with ID and symptomatic heart failure 2.

From the Research

Use of Ferric Carboxymaltose in Pediatric Patients

• Ferric carboxymaltose is used to treat iron deficiency anemia or iron deficiency without anemia in pediatric patients who have had a poor response to oral iron treatment 3.
• The treatment has been shown to be effective in achieving target ferritin levels and improving clinical symptoms in children and adolescents 3, 4.
• A study found that 85% of patients with complete data achieved the target ferritin level ≥ 30 µg/L after a single dose of ferric carboxymaltose, and 49% of patients with iron deficiency anemia showed a complete hematological response within 6-12 weeks 3.
• Ferric carboxymaltose has been approved for use in children aged > 1 year in the US, and has been found to be generally well-tolerated in pediatric patients 4.

Efficacy and Safety

• The efficacy of ferric carboxymaltose in treating iron deficiency anemia in pediatric patients has been demonstrated in several studies, with improvements in hemoglobin and iron indices observed 3, 4.
• The safety profile of ferric carboxymaltose in pediatric patients is similar to that in adults, with a low incidence of adverse events and no serious adverse events reported in most studies 3, 4.
• However, there is a need for prospective, randomized controlled trials to further establish the efficacy and safety of ferric carboxymaltose in pediatric patients 4.

Comparison to Other Treatments

• Ferric carboxymaltose has been compared to other intravenous iron preparations, and has been found to be effective and well-tolerated, with fewer infusions required to reach target iron levels 5.
• The treatment has also been compared to oral iron therapy, and has been found to be more effective in replenishing iron stores and correcting anemia in pediatric patients who have had a poor response to oral iron treatment 3, 6.