From the Guidelines
Orofer FCM is indicated for the treatment of iron-deficiency anemia and anemia associated with chronic kidney disease, particularly when oral iron supplements are ineffective or cannot be tolerated by the patient. This medication is specifically useful in clinical situations requiring rapid iron repletion, such as severe anemia, ongoing blood loss, or when patients have absorption issues in the gastrointestinal tract. The intravenous administration of ferric carboxymaltose allows for direct delivery of iron into the bloodstream, bypassing the digestive system entirely, making it an excellent option for patients with inflammatory bowel disease, malabsorption syndromes, or those who experience significant gastrointestinal side effects with oral iron therapy.
Clinical Conditions for Use
- Iron-deficiency anemia
- Anemia associated with chronic kidney disease
- Inflammatory bowel disease
- Malabsorption syndromes
- Patients undergoing dialysis
- Patients with decreased erythropoietin production and impaired iron utilization
Key Benefits
- Rapid iron repletion
- Improved hemoglobin production
- Enhanced oxygen-carrying capacity of the blood
- Suitable for patients with gastrointestinal issues or intolerance to oral iron supplements According to the study by 1, intravenous iron therapy with ferric carboxymaltose has been shown to improve patient self-reported quality of life, heart failure symptoms, and exercise capacity in patients with heart failure and reduced ejection fraction. The study also found that ferric carboxymaltose reduced the risk of hospitalization in patients with chronic heart failure.
Administration and Dosage
- Given intravenously by a healthcare professional
- Usually administered in two doses, seven days apart
- The usual dose for FCM in the USA is two individual doses of 750 mg each, whereas in Europe 1000 mg is routinely administered each dose, as noted in 1. It is essential to follow the recommended dosage and administration guidelines to ensure the safe and effective use of Orofer FCM, as supported by the evidence from 1.
From the Research
Clinical Conditions for Using Orofer FCM
The clinical conditions for using Orofer FCM, an iron replacement medication, include:
- Iron-deficiency anemia: Orofer FCM is used to treat iron-deficiency anemia, especially in cases where oral iron supplements are ineffective or intolerable 2, 3, 4, 5, 6.
- Anemia due to chronic kidney disease: Orofer FCM is also used to treat anemia due to chronic kidney disease, including non-dialysis-dependent chronic kidney disease (NDD-CKD) and dialysis-dependent chronic kidney disease (HD-CKD) 2, 3, 4, 6.
- Inflammatory bowel disease: Ferric carboxymaltose, the active ingredient in Orofer FCM, has been shown to be effective in treating iron-deficiency anemia in patients with inflammatory bowel disease 4.
- Heavy uterine bleeding: Ferric carboxymaltose has also been shown to be effective in treating iron-deficiency anemia in patients with heavy uterine bleeding 4.
- Postpartum iron-deficiency anemia: Ferric carboxymaltose has been shown to be effective in treating postpartum iron-deficiency anemia 4.
Key Points
- Orofer FCM is a non-dextran iron formulation that helps replenish iron stores in the body 2, 3, 4.
- It is administered intravenously (IV) by a healthcare professional, usually in two doses, seven days apart 2, 3.
- The efficacy and safety of Orofer FCM have been established in several clinical trials, including studies in patients with iron-deficiency anemia and chronic kidney disease 2, 3, 4, 5, 6.