What is the proper use of Ferinject (ferric carboxymaltose) for iron deficiency?

Ferinject (Ferric Carboxymaltose) - Proper Use for Iron Deficiency

Ferinject is indicated for intravenous iron replacement when oral iron is ineffective, not tolerated, or when rapid iron repletion is required, with a maximum single dose of 1000 mg administered over 15 minutes. 1

Indications for Use

When to Use Ferinject Over Oral Iron

• Intolerance to oral iron (gastrointestinal side effects such as constipation, diarrhea, nausea) 1
• Inadequate response to oral iron therapy after appropriate trial 1
• Active inflammatory conditions (e.g., inflammatory bowel disease) where oral iron absorption is compromised 2
• Need for rapid iron repletion (e.g., preoperative patient blood management) 1
• Chronic heart failure with iron deficiency (ferritin <100 μg/L or 100-299 μg/L with transferrin saturation <20%) 1

Diagnostic Criteria for Iron Deficiency

Iron deficiency is diagnosed when: 1

• Serum ferritin <100 μg/L, OR
• Serum ferritin 100-299 μg/L with transferrin saturation <20%

Administration Protocol

Dosing

Maximum single dose: 1000 mg of iron (20 mL) administered over minimum 15 minutes 1

Maximum cumulative dose: 1000 mg per week 1

Administration Methods

Ferinject can be given as: 1

• Undiluted slow bolus injection, OR
• Diluted infusion (avoid over-dilution):
  • 500 mg dose: 10 mL FCM in maximum 100 mL sterile 0.9% sodium chloride, minimum 6 minutes
  • 1000 mg dose: 20 mL FCM in maximum 250 mL sterile 0.9% sodium chloride, minimum 15 minutes

Setting Requirements

Must be administered where staff are trained and equipped to monitor for and manage hypersensitivity reactions 1

Resuscitation facilities must be available 1

Observe patients for adverse effects for at least 30 minutes following each injection 1

Contraindications

Absolute contraindications: 1

• Hypersensitivity to ferric carboxymaltose or any excipients
• Known serious hypersensitivity to other parenteral iron products
• Anemia not attributed to iron deficiency (e.g., other microcytic anemias)
• Evidence of iron overload or disturbances in iron utilization

Special Populations

Chronic Heart Failure

Intravenous ferric carboxymaltose should be considered in symptomatic patients with chronic systolic heart failure (LVEF <40%) and iron deficiency 1

• Improves symptoms, quality of life, NYHA class, and exercise capacity 1, 3
• Reduces heart failure hospitalizations 1, 3
• No clinical evidence for use in HFpEF (LVEF ≥50%) and limited evidence in HFmrEF (LVEF 40-49%) 1

Critically Ill Patients

In anemic critically ill patients with iron deficiency confirmed by low hepcidin levels, 1 g of iron as ferric carboxymaltose should be delivered 1

• Associated with reduction in length of hospital stay and 90-day mortality 1

Inflammatory Bowel Disease

Should be considered first-line therapy in patients with active inflammation where gastrointestinal absorption may be compromised 2

Monitoring

Initial Assessment

Calculate total iron need based on body weight and hemoglobin levels 1

Follow-up Monitoring

Re-evaluate iron status at 3 months after replacement 1

Avoid early re-evaluation (within 4 weeks) as ferritin levels increase markedly after IV iron and cannot be used as an indicator of iron status during this time 1

For chronic heart failure patients: evaluate iron status 1-2 times per year as part of routine practice 1

Repeat basic blood tests after 8-10 weeks to measure treatment success 1

Safety Profile

Common Adverse Effects (≥1% to <10%)

• Dizziness, headache 1, 4
• Hypertension 1
• Hypophosphatemia (transient, asymptomatic) 1, 5
• Injection-site reactions 1, 4
• Nausea 1, 4

Serious Adverse Events

Hypersensitivity reactions occur at low frequency (≥0.1% to <1%) 1

Risk of hypersensitivity reactions is very infrequent (<1:250,000 administrations) but may be life-threatening 1

Incidence of side effects with ferric carboxymaltose is similar to other intravenous compounds (22-29%), but no anaphylaxis was reported in initial studies 1

Cautions

Use with caution and seek specialist advice in: 1

• Acute or chronic infection (stop treatment in patients with ongoing bacteremia)
• Known drug allergies, severe asthma, eczema, or atopic allergies
• Immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis)
• Hemoglobin level >15 g/dL (safety not evaluated)

Advantages Over Other Formulations

Fewer infusions required compared to iron sucrose (200 mg maximum) or iron dextran 1

Better tolerated than oral ferrous sulfate, primarily due to lower incidence of gastrointestinal adverse effects 4, 6

Safer profile than high molecular weight iron dextran, which has been associated with serious reactions (0.6-0.7%) and fatalities 1