Contraindications for Ferric Carboxymaltose (FCM)
Do not administer ferric carboxymaltose to patients with hypersensitivity to FCM or its excipients, known serious hypersensitivity to other parenteral iron products, anemia not due to iron deficiency, or evidence of iron overload or disturbances in iron utilization. 1
Absolute Contraindications
The following are absolute contraindications to FCM administration:
- Hypersensitivity reactions: Any known hypersensitivity to the active substance, to FCM itself, or any of its excipients 1, 2, 3
- Cross-reactivity: Known serious hypersensitivity to other parenteral iron products 1, 2, 3
- Non-iron deficiency anemia: Presence of anemia not attributed to iron deficiency (e.g., other microcytic anemias) 1, 2
- Iron overload: Evidence of iron overload or disturbances in the utilization of iron 1, 4, 3
Critical Safety Thresholds
FCM should not be used in patients with hemoglobin levels >15 g/dL, as efficacy and safety have not been evaluated in this population. 1
High-Risk Situations Requiring Extreme Caution or Avoidance
Active Infection
- Use with extreme caution in patients with acute or chronic infection 1, 3
- Treatment with FCM must be stopped immediately in patients with ongoing bacteremia 1, 3
Allergic Predisposition
Patients at increased risk of hypersensitivity reactions include those with:
- History of severe asthma, eczema, or other atopic allergies 1, 3
- Known drug allergies 1, 3
- Immune or inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis) 1, 3
Repeat Infusion Requirements
FCM should be avoided in patients requiring repeat infusions due to recurrent blood loss or malabsorptive disorders, as it carries a significant risk (47-75% incidence) of treatment-emergent hypophosphatemia that can lead to osteomalacia and fractures. 4, 2 This hypophosphatemia can be severe and prolonged, lasting up to 6 months. 4
Pediatric Considerations
FCM has not been studied in children and is therefore not recommended in children under 14 years of age. 1
Critical Safety Monitoring
Anaphylaxis Management
- Although anaphylaxis with FCM is extremely rare, it constitutes a true medical emergency 4
- If anaphylaxis occurs, immediately discontinue the infusion and administer epinephrine 4
- Patients must be observed for adverse effects for at least 30 minutes following each intravenous injection 1, 4, 2, 3
- Document any reaction thoroughly for future reference 4
Important Caveat on Desensitization
For patients with a history of hypersensitivity reactions to iron preparations, successful desensitization protocols exist and can allow safe FCM administration under controlled conditions. 5 However, this should only be attempted in specialized settings with appropriate monitoring and resuscitation capabilities.
Note: The evidence provided does not support the interpretation that "FCM" refers to fluorescein contrast media. All guideline-level evidence clearly identifies FCM as ferric carboxymaltose, an intravenous iron preparation. 1, 4, 2, 3