What are the administration guidelines for Inj FCM (Iron Carboxymaltose)?

Administration Guidelines for Intravenous Ferric Carboxymaltose (FCM)

Ferric carboxymaltose (FCM) should be administered as either an undiluted slow bolus injection or as a diluted infusion, with a maximum recommended cumulative dose of 1000 mg iron per week and patients should be observed for at least 30 minutes after administration for potential adverse reactions. 1

Dosing and Administration Method

Dosing Guidelines

• Initial iron dose is calculated based on body weight and hemoglobin levels 1
• Maximum recommended cumulative dose: 1000 mg iron (20 mL FCM)/week 1
• In Europe/Asia: typically administered as a 1000 mg single infusion 1
• In the US: distributed as 750 mg vials, typically given as two doses separated by at least 7 days 2

Administration Methods

1. Undiluted slow bolus injection:

   • Administer at a rate of 100 mg/min 1
   • For a 1000 mg dose, administration time would be 15 minutes 1

2. Diluted infusion:

   • For 500 mg: dilute in 100 mL of 0.9% sodium chloride, infuse over minimum 6 minutes 1
   • For 1000 mg: dilute in 250 mL of 0.9% sodium chloride, infuse over minimum 15 minutes 1
   • Important: FCM should not be over-diluted as this affects drug stability 1

Monitoring and Safety Considerations

During Administration

• Patients must be observed for adverse effects for at least 30 minutes following each IV injection 1
• Administration should be performed in settings where staff are trained to monitor for and manage hypersensitivity reactions 1

Post-Administration Monitoring

• Re-evaluate iron status 3 months after administration 1
• Avoid early re-evaluation of iron status (within 4 weeks) as ferritin levels increase markedly following IV iron administration 1
• Monitor serum phosphate levels in patients at risk for chronic low serum phosphate or those requiring repeat courses of treatment 1, 2

Contraindications

1. Hypersensitivity to FCM or any of its excipients 1
2. Known serious hypersensitivity to other parenteral iron products 1
3. Anemia not attributed to iron deficiency (e.g., other microcytic anemia) 1
4. Evidence of iron overload or disturbances in iron utilization 1

Special Precautions

Use with Caution in:

• Patients with acute or chronic infection (stop treatment in ongoing bacteremia) 1
• Patients with known drug allergies, especially those with history of severe asthma, eczema, or atopic allergies 1
• Patients with immune or inflammatory conditions (e.g., SLE, rheumatoid arthritis) 1
• Patients with hemoglobin levels >15 g/dL 1

Risk of Hypophosphatemia

• FCM has been associated with treatment-emergent hypophosphatemia 1
• Higher risk in patients with:
  • Recurrent or ongoing blood loss (abnormal uterine bleeding, GI bleeding) 1
  • Malabsorptive disorders (bariatric surgery, IBD, celiac disease) 1
  • Normal renal function 1
  • Severe iron deficiency 1
  • Low baseline serum phosphate 1
• Consider alternative IV iron formulations for patients requiring repeated infusions 1

Follow-up and Re-treatment

• Re-evaluate iron status 3 months after administration 1
• Consider evaluating iron status 1-2 times per year in patients with chronic heart failure 1
• For patients requiring repeated infusions (ongoing blood loss, malabsorption), frequency depends on the degree of blood loss or malabsorption 1

Practical Considerations

• FCM can be administered in hospital or community settings with appropriate monitoring capabilities 1
• For heart failure patients with iron deficiency, FCM has shown benefits in improving symptoms and quality of life 1, 3
• While FCM has a higher acquisition cost than some other IV iron formulations, fewer administrations are needed, potentially making it cost-effective 4

By following these administration guidelines, healthcare providers can safely and effectively administer FCM to treat iron deficiency anemia in appropriate patients.