From the Guidelines
Ferric maltol is the most effective and best-tolerated iron formulation for treating iron deficiency anemia, particularly in patients with inactive inflammatory bowel disease, previous intolerance to traditional iron salts, or moderate iron deficiency anemia. According to the British Society of Gastroenterology guidelines for the management of iron deficiency anemia in adults 1, ferric maltol has been shown to normalize hemoglobin levels in 63-66% of cases after 12 weeks of treatment, with gastrointestinal side effects and treatment cessation rates comparable to placebo. The study also found that ferric maltol maintained iron loading and tolerance during a year of active treatment, with normalization of hemoglobin in 89% of cases 1.
The optimal dosage of ferric maltol is 30 mg twice daily, which is a relatively low iron content, resulting in a slow rate of iron loading, but with maintained tolerance and efficacy over time 1. While ferric maltol is more expensive than traditional iron salts, it is less expensive than parenteral iron formulations, making it a cost-effective option for patients who require long-term iron replacement therapy 1.
In comparison to other iron formulations, such as ferrous sulfate, ferrous gluconate, and ferrous fumarate, ferric maltol has been shown to have a better tolerability profile, with fewer gastrointestinal side effects, making it a suitable option for patients who are intolerant to traditional iron salts 1. The British Society of Gastroenterology guidelines also recommend that the initial treatment of iron deficiency anemia should be with one tablet per day of ferrous sulphate, fumarate, or gluconate, but if not tolerated, a reduced dose or alternative oral preparations, such as ferric maltol, should be considered 1.
Key points to consider when prescribing ferric maltol include:
- Dosage: 30 mg twice daily
- Tolerability: fewer gastrointestinal side effects compared to traditional iron salts
- Efficacy: normalization of hemoglobin levels in 63-66% of cases after 12 weeks of treatment
- Cost-effectiveness: less expensive than parenteral iron formulations, but more expensive than traditional iron salts
- Patient selection: suitable for patients with inactive inflammatory bowel disease, previous intolerance to traditional iron salts, or moderate iron deficiency anemia.
From the FDA Drug Label
The safety and efficacy of Injectafer for treatment of IDA were evaluated in two randomized, open-label, controlled clinical trials (Trial 1 and Trial 2). In these two trials, Injectafer was administered at a dose of 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron Table 5 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 35 or time of intervention. Table 6 shows the baseline and the change in hemoglobin from baseline to highest value between baseline and Day 56 or time of intervention.
The most effective iron formulation for treating iron deficiency anemia is ferric carboxymaltose (IV), as it has been shown to increase hemoglobin levels and improve iron stores in patients with IDA 2. Key benefits of ferric carboxymaltose (IV) include:
- Significant increases in hemoglobin levels
- Improvements in iron stores, as measured by ferritin and transferrin saturation
- Well-tolerated in patients with IDA, including those with chronic kidney disease In comparison, iron sucrose (IV) is also an effective treatment for IDA, but it may have a higher risk of adverse reactions, such as hypersensitivity reactions and hypotension 3. Main differences between ferric carboxymaltose (IV) and iron sucrose (IV) include:
- Dosage and administration: ferric carboxymaltose (IV) is administered at a dose of 15 mg/kg body weight, while iron sucrose (IV) is administered at a dose of 50-200 mg per treatment
- Safety profile: ferric carboxymaltose (IV) has a lower risk of adverse reactions compared to iron sucrose (IV)
From the Research
Iron Formulations for Treating Iron Deficiency Anemia
The most effective iron formulation for treating iron deficiency anemia can vary depending on several factors, including the patient's tolerance and the severity of the deficiency.
- Ferrous sulfate is a commonly prescribed oral iron supplement due to its low cost and high efficacy 4, 5.
- However, it can cause gastrointestinal side effects, which may reduce patient compliance 4, 6.
- Other oral iron formulations, such as ferric maltol and sucrosomial iron, have been developed to improve tolerability and efficacy 4, 7.
- Sucrosomial iron, in particular, has shown excellent gastrointestinal tolerance and higher iron intestinal absorption compared to oral iron salts 7.
- Intravenous iron formulations, such as ferric carboxymaltose, may be used in cases where oral iron supplementation is contraindicated or ineffective 8.
Tolerability of Iron Formulations
The tolerability of different iron formulations can vary significantly.
- A systematic review found that extended-release ferrous sulfate with mucoproteose had the lowest incidence of adverse effects (4.1% overall, 3.7% gastrointestinal) 6.
- Sucrosomial iron has also been shown to have excellent gastrointestinal tolerance, with a lower incidence of side effects compared to oral iron salts 7.
- Ferric carboxymaltose, an intravenous iron formulation, has been found to be effective in correcting iron-deficiency anemia with minimal side effects 8.
Efficacy of Iron Formulations
The efficacy of iron formulations can also vary depending on the patient population and the severity of the deficiency.
- Ferrous sulfate has been shown to be effective in correcting iron-deficiency anemia, but its use may be limited by gastrointestinal side effects 4, 5.
- Sucrosomial iron has been found to be effective in treating iron deficiency and iron deficiency anemia, with a lower cost and fewer side effects compared to intravenous iron 7.
- Ferric carboxymaltose has been shown to be effective in correcting iron-deficiency anemia in patients with advanced chronic kidney disease, with a significant reduction in treatment costs 8.