Ferric Carboxymaltose

What it is and how it works

Mechanism of Action Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.

Indications

Ferric carboxymaltose injection is indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Ferric carboxymaltose injection is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

Dosage and administration (summary)

• For patients weighing 50 kg or more, the recommended dosage is ferric carboxymaltose injection 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course. For adult patients weighing 50 kg or more, an alternative dose of ferric carboxymaltose injection 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. • For patients weighing less than 50 kg, the recommended dosage is ferric carboxymaltose injection 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course.

Contraindications

Ferric carboxymaltose injection is contraindicated in patients with a history of hypersensitivity to ferric carboxymaltose or any of its components . Hypersensitivity to ferric carboxymaltose injection or any of its inactive components.

Warnings and precautions

• Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after ferric carboxymaltose administration for at least 30 minutes and until clinically stable following completion of each administration. • Hypertension: Monitor patients closely for signs and symptoms of hypertension following each ferric carboxymaltose administration.

Pregnancy

Pregnancy Risk Summary Parenteral iron administration may be associated with hypersensitivity reactions , which may have serious consequences, such as fetal bradycardia (see Clinical Considerations ) . Advise pregnant women of the potential risk to a fetus.

Storage and supply

Ferric carboxymaltose injection is a dark brown, non-transparent, sterile, aqueous, isotonic colloidal solution for intravenous injection and supplied as follows: NDC 67457-797-15 750 mg iron/15 mL Single-Dose Vial Individually Boxed NDC 67457-797-99 750 mg iron/15 mL Single-Dose Vial Packages of 2 Store at 20°C to 25°C (68°F to 77°F).

Source: Ferric Carboxymaltose (Ferric Carboxymaltose) — US FDA prescribing information, 2026-08-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.