What it's for (Indications)
- Ferric carboxymaltose complex is indicated for the treatment of iron deficiency anemia (IDA) in adult patients and pediatric patients 1 year of age and older who have either intolerance to oral iron or have had an unsatisfactory response to oral iron.
- It is also indicated for the treatment of IDA in adult patients with chronic kidney disease (CKD) not on dialysis.
- The diagnosis of iron deficiency anemia must be confirmed by laboratory tests, including serum ferritin and transferrin saturation (TSAT), prior to administration.
- This intravenous iron formulation provides a rapid and effective means to replenish iron stores in patients unable to adequately absorb or tolerate oral iron supplements, thereby improving hemoglobin levels and reducing associated symptoms of anemia, such as fatigue and weakness, while bypassing potential gastrointestinal side effects of oral iron.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Ferric carboxymaltose is administered intravenously. For adult patients, the total cumulative dose is determined by baseline hemoglobin and body weight. Common dosing regimens include 750 mg administered as two doses separated by at least 7 days, or a single dose of 1000 mg depending on the individual's iron deficit and calculated iron requirement. The maximum single dose should not exceed 1000 mg of iron. Dosing for pediatric patients (1 year and older) is weight-based, typically 15 mg iron/kg body weight, not to exceed 750 mg per dose, administered as two doses separated by at least 7 days, up to a maximum cumulative dose of 1500 mg. Each dose should be infused undiluted or diluted in up to 250 mL of 0.9% sodium chloride, and infused over at least 15 minutes. Patients must be monitored for signs of hypersensitivity reactions during and following administration for a specified period, typically 30 minutes. |
Safety & Warnings
Common Side Effects
- The most frequently reported adverse reactions with ferric carboxymaltose include nausea, headache, dizziness, hypertension, injection site reactions (e.
- g.
- , discomfort, discoloration, swelling), and hypophosphatemia.
- Other common side effects may include flushing, altered taste (dysgeusia), diarrhea, constipation, rash, and abdominal pain.
- Serious but less common adverse events include hypersensitivity reactions, which can range from mild skin reactions (e.
- g.
- , urticaria) to severe anaphylaxis, requiring immediate medical intervention.
- Transient, asymptomatic reductions in serum phosphate levels are common; however, severe symptomatic hypophosphatemia requiring medical attention can occur.
- Patients may also experience temporary changes in blood pressure, including episodes of hypotension or sustained hypertension following infusion.
- Discoloration of the urine and fever have also been reported.
Serious Warnings
- Black Box Warning: **No Formal FDA Black Box Warning:** Ferric carboxymaltose does not carry a formal FDA-mandated Black Box Warning. However, serious and potentially life-threatening risks are associated with its administration and warrant significant caution and clinical oversight. **Serious Warnings:** 1. **Hypersensitivity Reactions:** Life-threatening hypersensitivity reactions, including anaphylaxis, have occurred with intravenous iron products, including ferric carboxymaltose. These reactions can be fatal. Patients must be monitored closely for signs and symptoms of hypersensitivity during and for at least 30 minutes following each administration. Resuscitation equipment, medications (e.g., epinephrine, antihistamines, corticosteroids), and personnel trained in the management of anaphylaxis must be immediately available. Patients with a history of multiple drug allergies or asthma may be at increased risk and should be evaluated carefully prior to administration. 2. **Symptomatic Hypophosphatemia (SHP):** Cases of severe, symptomatic hypophosphatemia requiring clinical intervention have been reported. This condition can lead to osteomalacia, bone pain, muscle weakness, and fatigue. Monitoring of serum phosphate levels should be considered, especially in patients at risk for low phosphate, such as those with gastrointestinal disorders causing malabsorption, prior history of low phosphate, or those receiving repeat doses. Clinicians should be vigilant for signs and symptoms of hypophosphatemia, and appropriate management should be instituted if it occurs.
- Serious warnings associated with ferric carboxymaltose include the potential for hypersensitivity reactions, including life-threatening anaphylactic reactions.
- Patients should be monitored for signs and symptoms of hypersensitivity for at least 30 minutes after each infusion, and appropriate medical facilities for managing anaphylaxis, including trained personnel and resuscitation equipment, must be immediately available.
- Furthermore, significant and potentially symptomatic hypophosphatemia (SHP) has been observed, particularly in patients with recurrent intravenous iron needs, underlying conditions predisposing to phosphate dysregulation (e.
- g.
- , vitamin D deficiency, malabsorption syndromes), or those receiving high cumulative doses.
- Blood pressure should be monitored during and after administration, as transient hypertension or hypotension can occur.
- Extravasation during administration may lead to persistent brown discoloration of the skin at the injection site.
- Use in patients with underlying liver disease or significant inflammation should be approached with caution, as it may affect iron utilization and metabolism and potentially worsen inflammation.
How it Works (Mechanism of Action)
Ferric carboxymaltose is a colloidal iron hydroxide complex with a carbohydrate shell (carboxymaltose). After intravenous administration, the iron complex is taken up by the reticuloendothelial system, primarily in the liver, spleen, and bone marrow. Within these cells, the iron is slowly released from the complex and then becomes available for binding to transferrin, the plasma iron transport protein. Subsequently, transferrin delivers iron to erythroid precursor cells in the bone marrow for incorporation into hemoglobin, which is crucial for oxygen transport, and to other tissues for incorporation into iron-containing enzymes. The stable non-ionic nature of the complex allows for high-dose iron administration without the risk of generating significant levels of free iron, thereby reducing the potential for oxidative stress and toxicity. This controlled release mechanism facilitates rapid replenishment of iron stores and effective increase of hemoglobin levels in iron-deficient individuals.
Commercial Brands (Alternatives)
No other brands found for this formula.