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FCM
FCM (ferric carboxymaltose) delivers iron directly into the bloodstream to replenish iron stores and treat iron deficiency anemia.
FCM (ferric carboxymaltose) delivers iron directly into the bloodstream to replenish iron stores and treat iron deficiency anemia. Used for Iron deficiency anemia in patients with chronic kidney disease, Iron deficiency anemia in patients intolerant to or with inadequate response to oral iron, Postpartum iron deficiency anemia.
At a glance
| Generic name | FCM |
|---|---|
| Also known as | Injectafer, Ferinject |
| Sponsor | AMAG Pharmaceuticals, Inc. |
| Drug class | Intravenous iron replacement agent |
| Target | Iron (Fe3+) delivery via transferrin-mediated uptake |
| Modality | Small molecule |
| Therapeutic area | Hematology |
| Phase | Phase 3 |
Mechanism of action
FCM is an intravenous iron replacement therapy that uses a carbohydrate shell to stabilize ferric iron, allowing rapid and safe delivery of iron to patients with iron deficiency. The iron is taken up by transferrin and incorporated into hemoglobin and iron storage proteins, restoring oxygen-carrying capacity and correcting anemia. This formulation enables high-dose iron administration with a favorable safety profile compared to older iron formulations.
Approved indications
- Iron deficiency anemia in patients with chronic kidney disease
- Iron deficiency anemia in patients intolerant to or with inadequate response to oral iron
- Postpartum iron deficiency anemia
Common side effects
- Injection site reactions
- Headache
- Nausea
- Dizziness
- Hypophosphatemia
Key clinical trials
- Effect of Intravenous Iron on Quality of Life in Older Patients With Acute Coronary Syndrome (PHASE4)
- Collaborative Targeted Case Management in Improving Functional Status in Patients With Stage III-IV Cancer (NA)
- Effect of Vitamin D Supplementation on Metabolic Parameters in Patients With Type 2 Diabetes and Vitamin D Deficiency (NA)
- Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic (NA)
- FOsfomycin for Male Urinary Tract Infection (PHASE3)
- The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department (PHASE4)
- The Impact of IV Iron on Exercise Capacity and Quality of Life in Pulmonary Hypertension (PHASE4)
- Iron Infusion in Patients Undergoing Transcatheter Aortic Valve Implantation (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- FCM CI brief — competitive landscape report
- FCM updates RSS · CI watch RSS
- AMAG Pharmaceuticals, Inc. portfolio CI