The FDA has recently approved ferric carboxymaltose injection (sold under the brand name Injectafer) as a treatment for iron deficiency in adult patients with heart failure (HF) and iron deficiency. This makes it the first and only intravenous (IV) iron replacement therapy indicated for this specific patient population.
Previously, ferric carboxymaltose injection was only approved for the treatment of iron deficiency anemia in patients aged 1 year and older who had intolerance to oral iron or an unsatisfactory response to it. It was also approved for adult patients with non-dialysis-dependent chronic kidney disease.
For the treatment of iron deficiency in adults with HF and New York Heart Association class II/III symptoms, the dosing regimen of ferric carboxymaltose injection is based on patient weight and hemoglobin levels. The dosage can range from a single 500 mg dose to up to two 1000 mg doses separated by 6 weeks. Maintenance doses of 500 mg may also be given at 12, 24, and 36 weeks based on serum ferritin levels and transferrin saturation value.
A trial called HEART-FID, presented at the European Society of Cardiology Congress 2023, demonstrated the efficacy of ferric carboxymaltose injection in reducing deaths and HF hospitalizations in adults with HF with reduced ejection fraction. The trial also showed a small improvement in the 6-minute walking distance.
The safety profile of ferric carboxymaltose injection was found to be consistent with previous reports, with no new safety concerns observed. Although the trial did not meet the prespecified significance level, it provided positive findings regarding the treatment of iron deficiency in HF patients.
Additional studies have also shown the benefits of ferric carboxymaltose injection in improving quality of life, exercise capacity, fatigue symptoms, and physical function in patients. The drug has potential clinical advantages related to survival, HF hospitalizations, and overall cardiovascular health.
These findings suggest that ferric carboxymaltose injection can be an effective tool in helping patients with HF and iron deficiency. It may also be used to reduce clinical events and improve quality of life in patients following an acute HF episode, regardless of their diabetes status.
Overall, ferric carboxymaltose injection offers promising outcomes for patients with HF and iron deficiency, providing a valuable treatment option for this population.
– INJECTAFER approved in the U.S. for the treatment of iron deficiency in adult patients with heart failure. Business Wire. June 5, 2023.
– Harrington J, Mentz RJ, Rockhold FW, et al. Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial. Am Heart J. 2023;266:25-31.
– Kwong WJ, Numan S, Hunter TD, Alves D, Patel A, Shanbhag S. Patient-reported outcomes after ferric carboxymaltose treatment for iron deficiency anemia: a prospective observational study. Int J Gen Med. 2023;16:3291-3300.
– Rosano G, Ponikowski P, Vitale C, et al. Intravenous ferric carboxymaltose for iron repletion following acute heart failure in patients with and without diabetes: a subgroup analysis of the randomized AFFIRM-AHF trial. Cardiovasc Diabetol. 2023;22(1):215.