Ferric Carboxymaltose is a novel intravenous iron formulation primarily indicated for:

（1）Treatment of iron deficiency anemia‌: Adult patients with inadequate response to or intolerance of oral iron therapy (e.g., severe gastrointestinal adverse effects);

‌（2）Anemia management in chronic kidney disease (CKD)‌: Particularly for iron repletion in non-dialysis-dependent patients;

‌（3）Special population applications‌: Expanded FDA approval for pediatric patients aged ≥1 year and pregnant/postpartum women.

Comparative Advantages of Ferric Carboxymaltose vs. Other Intravenous Iron Preparations

‌1. Safety Advantages‌

‌（1）No dextran-related allergy risk‌: Lacks dextran structure, avoiding severe hypersensitivity reactions (e.g., hypotension, dyspnea) associated with iron dextran;

（2）Low free iron release‌: Core-shell nanostructure (β-FeOOH core + carboxymaltose shell) stabilizes iron binding, with free iron release <10% of iron dextran, reducing oxidative stress risks;

‌（3）Broad applicability‌: FDA-approved for iron deficiency in heart failure patients (improving 6-minute walk distance by 18m vs. placebo -7m) and maternal populations, with safety comparable to oral iron.

‌2. Administration Efficiency‌

‌（1）High-dose single infusion‌: Delivers 750mg iron in 15 minutes, requiring only 1-2 doses (total 1500mg), whereas iron sucrose necessitates multiple infusions (≤300mg/session);

（2）Reduced infusion time‌: Full treatment completed in 30 minutes (split into 2 sessions), achieving >50% time savings compared to traditional iron preparations.

‌3. Efficacy and Cost-Effectiveness‌

‌（1）Rapid anemia correction‌: Hemoglobin levels rise significantly within 1 week post-injection; ferritin restoration 3-4× faster than oral iron (ferritin increase: 269 ng/mL/24 weeks);

‌（2）Lower overall costs‌: Despite higher unit price vs. iron sucrose, shorter treatment duration and reduced hospitalization decrease total costs by 20%-30%.

‌4. Technological Distinctiveness‌

（1）Third-generation iron formulation‌: Precise molecular weight control (150-220 kDa) and complex manufacturing create imitation barriers;

（2）Leading in expanded indications‌: First global IV iron approved for heart failure-related iron deficiency, covering >2 million patients across 84 countries