What is IV carboxymaltose (Intravenous carboxymaltose)?

From the Guidelines

Intravenous iron carboxymaltose should be administered at a dose of 500-1000 mg over at least 15 minutes, with the exact dose calculated based on the patient's weight and hemoglobin level, to treat iron deficiency anemia when oral iron supplements are ineffective or cannot be tolerated. This recommendation is based on the most recent and highest quality study available, which provides guidance on the administration and monitoring of intravenous ferric carboxymaltose therapy 1. The study suggests that ferric carboxymaltose contains 50 mg iron/mL, and the maximum recommended cumulative dose is 1000 mg iron (20 mL FCM)/week.

Key Considerations

• The determination of the initial iron need is calculated based on body weight and Hb levels, rather than ferritin or TSAT levels 1.
• Intravenous FCM can be given as an injection or infusion, and patients should be observed for adverse effects for at least 30 min following each IV injection 1.
• After IV administration of the correction dose, iron status should be re-evaluated at 3 months, as early re-evaluation of iron status is important 1.

Benefits and Risks

• Iron carboxymaltose offers advantages over older IV iron preparations, including faster administration time and fewer allergic reactions.
• Common side effects include headache, nausea, and hypophosphatemia, and patients may experience a temporary discoloration of urine.
• Patients typically notice improvement in fatigue and other anemia symptoms within 1-2 weeks after treatment.

Clinical Guidelines

• The 2017 ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure recommends that intravenous iron replacement might be reasonable to improve functional status and QoL in patients with NYHA class II and III HF and iron deficiency 1.
• The guideline suggests that routine baseline assessment of all patients with HF includes an evaluation for anemia, and intravenous repletion of iron may improve exercise capacity and QoL.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Intravenous Iron Formulations

• Ferric carboxymaltose is a commonly used intravenous iron formulation, which has been shown to be effective and safe in treating iron deficiency anemia 2, 3, 4.
• Other intravenous iron formulations include iron dextran, iron derisomaltose, ferrumoxytol, iron sucrose, and sodium ferric gluconate 3, 5.

Efficacy and Safety

• Intravenous iron therapy has been shown to be effective in improving hemoglobin levels and quality of life in patients with iron deficiency anemia 2, 3, 4.
• The safety profile of intravenous iron formulations is generally good, with a low risk of severe infusion reactions (<1%) 3.
• However, hypophosphatemia is a potential complication of intravenous iron therapy, particularly with ferric carboxymaltose 3.

Clinical Use

• Intravenous iron therapy is often reserved for patients with intolerance or unresponsiveness to oral iron, or when rapid correction of iron deficit is required 3.
• In patients with inflammation, iron-deficiency should be suspected as a cause of anemia even if serum ferritin is normal 3.
• Single-dose intravenous iron therapy has been shown to be effective in reducing the incidence of low birthweight infants and improving maternal anemia in pregnant women with iron deficiency anemia 6.

Specific Formulations

• Ferric carboxymaltose has been shown to be effective in reducing the incidence of low birthweight infants and improving maternal anemia in pregnant women with iron deficiency anemia 6.
• Ferric derisomaltose has also been shown to be effective in improving maternal anemia in pregnant women with iron deficiency anemia, although its effect on low birthweight infants is unclear 6.