Introduction

Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.

Uses

Ferric carboxymaltose is an iron replacement therapy used to treat iron deficiency anemia in adults with intolerance or inadequate clinical response to oral iron or those who have non-dialysis dependent chronic kidney disease.

Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease.

Associated Conditions

Iron Deficiency Anemia (IDA)

Pharmacodynamics

When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%. In patients with iron deficiency, the red cell uptake ranged from 91% to 99%. In patients with renal anemia, the red cell uptake ranged from 61% to 84%.

Mechanism of Action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.

Absorption

When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).

Volume of Distribution

3 L

Route of Elimination

Renal elimination of iron was negligible.

Half Life

7 to 12 hours.

Toxicity

The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.

Food Interactions

No interactions found.

Dosage

The posology of Ferric Carboxymaltose follows a stepwise approach:

determination of the individual iron need
calculation and administration of the iron dose(s)
post-iron repletion assessments.

Step 1: Determination of the iron need: The individual iron need for repletion using Fematos is determined based on the patient's body weight and haemoglobin (Hb) level. The following list for determination of the iron need:

Hb <10 g/dl

below 35 kg: 500 mg
35 kg to <70 kg: 1500 mg
70 kg and over: 2000 mg

Hb 10 to 14 g/dl

below 35 kg: 500 mg
35 kg to <70 kg: 1000 mg
70 kg and over: 1500 mg

Hb >14 g/dl

below 35 kg: 500 mg
35 kg to <70 kg: 500 mg
70 kg and over: 500 mg

Step 2: Calculation and administration of the maximum individual iron dose(s): Based on the iron need determined above the appropriate dose(s) of Ferric Carboxymaltose should be administered taking into consideration the following:

A single Ferric Carboxymaltose administration should not exceed:

15 mg iron/kg body weight (for administration by intravenous injection) or 20 mg iron/kg body weight (for administration by intravenous infusion)
1,000 mg of iron (20 ml Ferric Carboxymaltose)
The maximum recommended cumulative dose of Ferric Carboxymaltose is 1000 mg of iron per week.

Step 3: Post-iron repletion assessments: Re-assessment should be performed by the clinician based on the individual patient's condition. The Hb level should be re-assessed no earlier than 4 weeks post final Ferric Carboxymaltose administration to allow adequate time for erythropoiesis and iron utilisation. In the event the patient requires further iron repletion, the iron need should be recalculated using above list.

Medical review

Last reviewed: 24 Jul 2026

Medically reviewed by:

This is general information, not personal medical advice. Consult a doctor before taking any medicine.