Ferric Carboxymaltose Infusion Rate
Ferric carboxymaltose should be administered as an intravenous infusion over 15-30 minutes for doses up to 1000 mg, diluted in 100 mL of normal saline. 1
Dosing and Administration Guidelines
Standard Administration Protocol
- Ferric carboxymaltose (FCM) must be diluted in 100 mL of normal saline before administration 1
- The recommended infusion time is 15-30 minutes for doses up to 1000 mg 1, 2
- 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
- Patients should be observed for adverse effects for at least 30 minutes following each IV injection 1
Dosing Based on Patient Characteristics
- For patients weighing ≥50 kg with hemoglobin >10 g/dL, administer 1000 mg as a single dose 2, 1
- For patients weighing ≥50 kg with hemoglobin ≤10 g/dL, administer 1500 mg (typically divided into two infusions) 2, 3
- For patients weighing <50 kg with hemoglobin >10 g/dL, administer 500 mg as a single dose 3
- For patients weighing <50 kg with hemoglobin ≤10 g/dL, administer 1000 mg as a single dose 3
Advantages of Ferric Carboxymaltose
- FCM can deliver large doses (up to 1000 mg) in a single short infusion, making it more convenient than other IV iron formulations 2, 4
- It allows for controlled delivery of iron to target tissues with minimal risk of releasing large amounts of ionic iron in the serum 4
- FCM has been shown to be effective across various conditions associated with iron deficiency, including chronic kidney disease, inflammatory bowel disease, and heart failure 1, 5
- It produces rapid improvements in hemoglobin levels, with increases typically seen within 1-2 weeks of treatment 1, 6
Monitoring and Follow-up
- Laboratory evaluation following IV iron should include a complete blood count and iron parameters (ferritin, transferrin saturation) 4-8 weeks after the last infusion 1
- Do not evaluate iron parameters within the first 4 weeks after administration as circulating iron can interfere with assay results 1, 3
- Hemoglobin concentrations 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 used with caution in patients who require repeat infusions 1, 7
- The British Society of Gastroenterology notes that hypophosphatemia rates are higher with ferric carboxymaltose (58%) than with iron derisomaltose (4%) or iron sucrose (1%) 7
- Most hypophosphatemia cases are biochemically moderate (serum phosphate 0.32–0.64 mmol/L) and asymptomatic, resolving without intervention 7
- Use with caution in patients with acute or chronic infection; treatment should be withheld in patients with bacteremia 1, 7
- 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
Alternative Administration Methods
- A Phase II single-arm study has shown that undiluted FCM can be administered as a rapid bolus injection without serious adverse events, though this is not the standard recommended approach 8
- This alternative method could potentially provide a more efficient approach for treating patients in ambulatory settings, but the standard infusion protocol remains the recommended method 8
Comparison with Other IV Iron Formulations
- Iron sucrose requires multiple infusions because the maximum dose per administration is 200 mg 7
- Low molecular weight iron-dextran can be given as a total dose but requires a much longer infusion time (4-6 hours) 7
- Ferric derisomaltose (previously iron isomaltoside 1000) can be administered as a single dose of up to 1000 mg over at least 20 minutes 3
- FCM is generally better tolerated than oral iron preparations, with fewer gastrointestinal adverse effects 5