How is ferric carboxymaltose (intravenous iron) administered?

Administration of Ferric Carboxymaltose

Ferric carboxymaltose (FCM) should be diluted in 100 mL of normal saline and infused over 20-30 minutes, with appropriate monitoring for infusion reactions. 1

Dosing Information

• FCM is a macromolecular ferric hydroxide carbohydrate complex that allows for slow release of elemental iron after injection 1
• In the United States, FCM is distributed as 750 mg vials with a label recommending two doses 1 week apart 1
• Throughout Europe and Asia, FCM is routinely administered as a 1000 mg single infusion 1
• The maximum recommended dose in the US is 750 mg per administration 2
• For patients with heart failure, the European Society of Cardiology recommends dosing based on weight and hemoglobin levels 3:
  • For patients ≥50 kg with hemoglobin >10 g/dL: 1000 mg as a single dose
  • For patients ≥50 kg with hemoglobin ≤10 g/dL: 1500 mg as a single dose
  • For patients <50 kg with hemoglobin >10 g/dL: 500 mg as a single dose
  • For patients <50 kg with hemoglobin ≤10 g/dL: 1000 mg as a single dose

Administration Procedure

• FCM must be diluted in 100 mL of normal saline before administration 1
• The infusion should be administered over 20-30 minutes 1
• Patients should be observed for adverse effects for at least 30 minutes following each IV injection 1
• Do not administer if hemoglobin >15 g/dL 3

Monitoring and Follow-up

• Laboratory evaluation following IV iron should include a complete blood count (CBC) and iron parameters (ferritin, percent transferrin saturation) 4-8 weeks after the last infusion 1
• Iron parameters should not be evaluated within 4 weeks of administration as circulating iron interferes with the assay leading to inaccurate results 1, 4
• Hemoglobin concentrations should increase within 1-2 weeks of treatment and should increase by 1-2 g/dL within 4-8 weeks of therapy 1
• For patients with heart failure, iron status should be re-evaluated at 3 months 1

Important Considerations and Cautions

• FCM has been associated with treatment-emergent hypophosphatemia and should be avoided in patients who require repeat infusions 1, 5
• Contraindications include hypersensitivity to FCM or its excipients, known serious hypersensitivity to other parenteral iron products, anemia not attributed to iron deficiency, and evidence of iron overload 1, 3
• Use with caution in patients with acute or chronic infection (stop treatment in patients with bacteremia) 1
• Use with caution in patients with known drug allergies, especially those with history of severe asthma, eczema, or atopic allergies 1
• Excessive dosages may lead to accumulation of iron in storage sites potentially leading to hemosiderosis 2
• Common adverse events include headache, dizziness, nausea, abdominal pain, constipation, diarrhea, rash and injection-site reactions 6

Advantages of FCM

• FCM can be administered in a large dose over a short time frame (15-30 minutes) 1, 7
• It has been shown to be safe and efficacious across various conditions associated with iron deficiency, including chronic kidney disease, pregnancy, heavy uterine bleeding, inflammatory bowel disease, and congestive heart failure 1
• FCM was the first IV iron formulation to be associated with fewer cardiovascular events and hospitalizations after administration for iron deficiency in patients with congestive heart failure 1
• It is generally better tolerated than oral iron therapy, with fewer gastrointestinal side effects 7