What is the infusion rate of Ferric Carboxymaltose (FCM) for treatment of anemia in a patient with severe anemia (hemoglobin level of 6.6 g/dL)?

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Ferric Carboxymaltose Infusion Rate for Severe Anemia

For a 60-year-old patient with hemoglobin of 6.6 g/dL, administer ferric carboxymaltose (FCM) 1000 mg intravenously over a minimum of 15 minutes. 1, 2

Dosing Protocol

The FDA-approved dosing for severe anemia (Hb <10 g/dL) in patients weighing ≥50 kg is 15 mg/kg body weight up to a maximum single dose of 750 mg, repeated after at least 7 days for a cumulative dose of 1,500 mg. 1 However, clinical practice and European guidelines support single doses up to 1000 mg. 3, 2

Infusion Rate Specifications

  • Administer doses up to 1000 mg over a minimum of 15 minutes 1, 2, 4
  • For doses exceeding 1000 mg, extend infusion time to at least 30 minutes 5
  • No test dose is required before FCM administration 6

Clinical Context for This Patient

This patient's hemoglobin of 6.6 g/dL represents severe anemia requiring urgent correction. The FDA label specifically studied patients with hemoglobin levels in this range (as low as 6.7 g/dL in clinical trials). 1, 7

Dosing Strategy

For patients with hemoglobin ≤10 g/dL and body weight ≥50 kg, the recommended approach is:

  • First dose: 750-1000 mg FCM over 15 minutes 1, 2
  • Second dose: 750-1000 mg FCM administered at least 7 days after the first dose 1
  • Total cumulative dose: 1,500-2,000 mg to achieve full iron repletion 1, 7

The European Society of Cardiology recommends 1500 mg as a single dose for patients ≥50 kg with hemoglobin ≤10 g/dL, though this may require extended infusion time. 5

Expected Outcomes

Hemoglobin should increase by 1-2 g/dL within 4-8 weeks of therapy. 5 In clinical trials of patients with severe anemia (mean baseline Hb 9.0-9.1 g/dL), FCM produced mean hemoglobin increases of 2.2-2.9 g/dL by day 35. 1

Rapid improvements occur within the first 1-2 weeks, with peak hemoglobin typically reached between days 35-56. 1, 4

Monitoring Parameters

Do not check iron parameters (ferritin, transferrin saturation) within the first 4 weeks after administration, as circulating iron interferes with assay results. 5

Reassess hemoglobin and iron parameters at 4-8 weeks post-infusion to determine if additional dosing is needed. 5, 1

Safety Considerations

FCM is well-tolerated with most adverse events being mild to moderate. 2, 4 Common side effects include headache, dizziness, nausea, and injection-site reactions. 2

The most important safety consideration is transient hypertensive episodes, which occur more frequently than with iron sucrose but are predominantly transient. 8

Contraindications include hemoglobin >15 g/dL, though this is not relevant for this patient. 5

Practical Administration

The 15-minute infusion time represents a significant advantage over older iron formulations like iron sucrose, which require multiple 200 mg doses administered 2-3 times weekly. 1, 2 This allows for complete iron repletion in just 1-2 visits rather than 5-10 visits. 6, 4

References

Guideline

Iron Deficiency Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Iron Deficiency Anemia Treatment with Ferric Derisomaltose

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Ferric carboxymaltose in patients with iron-deficiency anemia and impaired renal function: the REPAIR-IDA trial.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2014

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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