ferric carboxymaltose

Action and Spectrum

Actions and Spectrum:

ferric carboxymaltose is an iron-based medication used to treat iron deficiency anemia. Its actions include:

• Increasing iron stores in the body
• Improving hemoglobin levels
• Relieving anemia-related symptoms.

In terms of its spectrum, ferric carboxymaltose is indicated for adults and children over 1 year old with iron deficiency anemia who cannot tolerate oral iron or have unsatisfactory response to oral iron.

Drug Interaction

Adverse Reaction

Frequency Defined 

>10% 

Hypophosphatemia (13%)

1-10%

Hypertension (1-4%

Injection site reactions (3-4%)

Flushing (0.3-4%)

Nausea (1-7.2%)

Dizziness (1-2.1%)

Erythema (0.3-3%)

Hyperphosphatemia (1-2.1%)

Injection site extravasation (0.2-2%)

Vomiting (0.2-2%

Injection site discoloration (<1.4%)

Hepatic enzyme increased (1.2%)

Headache (1-1.3%)

Rash (1-1.2%)

Hypotension (<1%)

Dysgeusia (1-1.2%)

Black Box Warning

Black Box Warning

The black box warning for ferric carboxymaltose states that severe allergic reactions have been reported in some patients receiving the medication.

Contraindication / Caution

Contraindication/Caution:

Ferric carboxymaltose is contraindicated in individuals with an allergy or hypersensitivity to the drug. It is also contraindicated in individuals with iron overload or iron-storage disease.

Caution should be exercised in individuals with a history of cardiac disease, liver disease, or kidney disease. Ferric carboxymaltose should also be used with caution in individuals with low blood pressure or a history of low blood pressure.

It is important to inform the healthcare provider of any pre-existing medical conditions or medications being taken before starting ferric carboxymaltose treatment.

Pregnancy / Lactation

Pregnancy warnings:   

US FDA pregnancy category: N/A

Lactation:  

Excreted into human milk is known

Pregnancy Categories:        

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.

Category B: There were lack of studies on pregnant women and no evidence of risk to the foetus in animal experiments.

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.

Category D: adequate data available with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology: 

Ferric carboxymaltose (FCM) is a iron-containing compound used to treat iron deficiency anemia. It is an intravenous iron preparation that works by replenishing iron stores in the body.

Pharmacodynamics: 

Mechanism of action: FCM works by binding to the iron transport protein transferrin, which then delivers iron to the erythrocytes (red blood cells) for hemoglobin synthesis.

Pharmacokinetics:  

Absorption 

ferric carboxymaltose is absorbed rapidly from the gastrointestinal tract, with peak iron levels reached within 2 hours of administration.

Distribution 

Iron from ferric carboxymaltose is distributed to the various tissues of the body, including red blood cells, where it is incorporated into hemoglobin.

Metabolism 

ferric carboxymaltose is metabolized to ferric iron, which is incorporated into hemoglobin or stored in the body as ferritin

Elimination and Excretion 

Iron is excreted from the body primarily through the feces. A small amount may also be excreted through the urine

Adminstartion

Administration: 

IV administration

ferric carboxymaltose is an intravenous iron replacement therapy. It is administered as a slow injection into a vein over a 15-minute period. The recommended dosage and frequency of administration depend on the patient’s iron-deficiency anemia status and hemoglobin levels.

It is important to monitor patients for potential adverse reactions, such as allergic reactions or hypersensitivity, during and after administration.

Patient Information Leaflet

Patient information leaflet

Generic Name: ferric carboxymaltose

Why do we use ferric carboxymaltose?

ferric carboxymaltose is used to treat iron-deficiency anemia, which is a condition where the body doesn’t have enough iron to produce hemoglobin. ferric carboxymaltose provides iron quickly and effectively, increasing hemoglobin levels and improving symptoms of iron-deficiency anemia such as fatigue, weakness, and shortness of breath.

It is commonly used in patients who have difficulty tolerating oral iron supplements or who have conditions that prevent them from absorbing enough iron from food.