By: Davidta Brown, Staff Editor
For the estimated 7.5 million individuals in the United States living with iron deficiency anemia (IDA), there is now a new alternative to iron supplements or time-consuming, repetitive infusions. On July 25, 2013, the FDA approved ferric carboxymaltose injection (Injectafer®) for the treatment of IDA, especially in patients who cannot tolerate or have poor responses to oral iron.1,2 The iron injection is produced by American Regent Inc., a division of the Swiss company Luitpold Pharmaceuticals Inc., and is the first high-dose, non-dextran, intravenous iron treatment offered for a wide variety of patient profiles.1
Ferric carboxymaltose injection (Injectafer®) is an iron replacement product intended for individuals with iron deficiency caused by, or concurrent with, cancer, various gastrointestinal disorders, abnormal uterine bleeding, or chronic kidney disease.3 The most unique benefit that this treatment provides over traditional IDA management methods is the significant decrease in administration time. While most non-dextran iron infusions must be given as multiple doses, spread out over the course of several weeks, a full treatment with Injectafer® can be administered in one 15-minute dose.1,4
The success of the new IDA treatment in patients with diverse causes of iron-deficiency was confirmed through two major, randomized clinical trials. The first trial, in which 94% of the patients were female and the primary etiologies were heavy uterine bleeding and disorders of the GI tract, intended to observe the efficacy of ferric carboxymaltose injection in patients who were intolerant to or had previously displayed an unsatisfactory response to oral iron supplements.2 In the second trial, most of the patients had chronic kidney disease, specifically of the type in which patients were not dependent on dialysis.2 In both trials, Injectafer® was administered either at a dosage of 15mg/kg of body weight, up to a maximum single dose of 750mg, or as two separate doses separated by at least a week, up to a maximum cumulative dose of 1500mg.1
The results of each trial indicated a greater improvement in hemoglobin levels when Injectafer® was administered rather than an alternative source of iron, though the benefits were greater among patients in the first clinical trial. For example, the maximum change in hemoglobin levels on average was 1.6g/dL for trial 1 participants, who received ferric carboxymaltose injections, as opposed to 0.8g/dL for those who received oral iron.2 Individuals in the kidney disease trial who received Injectafer® were compared to those receiving another common iron injection for people with kidney disease, iron sucrose injection (Venofer®).2 The increase in hemoglobin was less significant here, with levels of 1.1g/dL on the new treatment in comparison to 0.9g/dL on the old.2
Since the creators of Injectafer® intended for the drug to serve a wide variety of patients, it was important that any side effects that appeared during the clinical trial period be minimal. Fortunately, the results of both trials were positive in this regard. The most common reaction was dizziness or nausea immediately after the administration of ferric carboxymaltose injection, and this occurred in only 6% of the tested subjects.3 In addition, hypertension was noted in 3.8% percent of the patients involved in the clinical trial.3 The most serious reactions were anaphylactic in nature, and side effects of this sort were displayed in 0.1% of the subjects.3
Luitpold Pharmaceuticals Inc. intends to manufacture and market Injectafer® internationally, under the name Ferrinject®.1 At present, the Swiss pharmaceutical company is the only one producing ferric carboxymaltose injections for IDA. However, if the alternative treatment stands the test of time and continues to meet the unique needs of individuals with iron-deficiency anemia, there is no doubt that other companies will join Luitpold Pharmaceuticals in this newly created facet of the iron-supplement market.
- Medscape Medical News. FDA Approves Injectafer for Iron Deficiency Anemia. Available at: http://www.medscape.com/viewarticle/808800. Accessed August 14, 2013.
- U.S. Food and Drug Administration. Highlights of Prescribing Information. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203565s000lbl.pdf
- American Regent, Inc. Injectafer® (ferric carboxymaltose injection). Available at: http://www.injectafer.com
- American Society of Hematology. Iron-Deficiency Anemia. Available at: http://www.hematology.org/patients/blood-disorders/anemia/5263.aspx