From the Guidelines
Intravenous ferrous carboxymaltose, specifically ferric carboxymaltose (FCM), is a recommended treatment for iron deficiency anemia, with a typical dose of 1000 mg administered in 15 to 30 minutes, as it has been shown to be safe and efficacious across various conditions associated with iron lack. When considering the use of intravenous iron, it is essential to weigh the benefits and risks, particularly in patients with certain medical conditions. According to the expert consensus guidelines published in the American Journal of Hematology in 2024 1, FCM is a macromolecular ferric hydroxide carbohydrate complex that facilitates slow release of elemental iron after injection. This allows for a large dose to be administered quickly, making it a convenient option for outpatient settings.
Some key points to consider when administering FCM include:
- The medication should be diluted in 100 mL of normal saline and infused over 20–30 min, with precautions to observe for acute onset of minor infusion reactions 1.
- FCM has been associated with treatment-emergent hypophosphatemia, and therefore, should be avoided in patients who require repeat infusions 1.
- The typical adult dose is 1000 mg, which can be administered as a single infusion in many countries, but in the United States, it is distributed exclusively as a 750 mg vial, requiring two doses 1 week apart for a total of 1500 mg 1.
The benefits of using FCM include its ability to rapidly restore iron levels without gastrointestinal side effects, making it particularly useful for patients with inflammatory bowel disease, heavy menstrual bleeding, or those undergoing surgery. Additionally, FCM has been shown to be associated with fewer cardiovascular events and hospitalizations after administration for iron deficiency in patients with congestive heart failure 1.
Overall, FCM is a safe and effective treatment option for iron deficiency anemia, with a convenient administration schedule and a favorable safety profile, making it a valuable treatment option for patients who require rapid iron repletion.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Intravenous Ferric Carboxymaltose
- Ferric carboxymaltose is a stable complex with a low immunogenic potential, allowing for the administration of large doses in a single session without the need for a test dose 2.
- It is a non-dextran-containing intravenous iron preparation, which reduces the risk of anaphylactic reactions compared to dextran-containing preparations 2, 3.
Efficacy and Safety
- Ferric carboxymaltose has been shown to be effective in treating iron deficiency anemia, with significant improvements in hemoglobin concentration and mean corpuscular volume (MCV) 4, 5.
- The safety profile of ferric carboxymaltose is acceptable, with a low risk of severe infusion reactions and no significant difference in safety compared to other intravenous iron preparations 3, 4.
- However, ferric carboxymaltose has been associated with a risk of hypophosphatemia, which can cause severe and potentially irreversible clinical complications 3, 5.
Administration and Dosage
- Ferric carboxymaltose can be administered in two rapid injections or infusions, with a full dose of up to 1500 mg 4.
- The optimal dose of ferric carboxymaltose for treating iron deficiency anemia is still being evaluated, with studies suggesting that a single dose of 500 mg may be effective in achieving significant improvements in hemoglobin concentration and MCV 5.
Comparison to Other Treatments
- Ferric carboxymaltose has been compared to other intravenous iron preparations, such as iron sucrose, and has been shown to have similar efficacy and safety profiles 4.
- Oral iron supplementation is still the recommended first-line treatment for iron deficiency anemia, but intravenous ferric carboxymaltose may be preferred in cases where rapid correction of iron deficit is required or where oral iron is not tolerated 3, 6.