Injectafer Approved by FDA as First Intravenous Iron Replacement Therapy for Iron Deficiency in Heart Failure Patients

Injectafer Approved by FDA as First Intravenous Iron Replacement Therapy for Iron Deficiency in Heart Failure Patients

The FDA has recently approved the use of ferric carboxymaltose injection (brand name Injectafer) for the treatment of iron deficiency in adult patients with heart failure (HF) and iron deficiency. This approval makes Injectafer the first and only intravenous (IV) iron replacement therapy indicated for this particular patient population.

Previously, ferric carboxymaltose injection was only indicated for the treatment of iron deficiency anemia in patients 1 year and older with intolerance to oral iron or an unsatisfactory response to oral iron, as well as adult patients with non-dialysis-dependent chronic kidney disease.

The dosing regimen for Injectafer in adult patients with HF and New York Heart Association class II/III symptoms is based on patient weight and hemoglobin level. The initial dose is a single 500 mg dose, which can be increased to up to two 1000 mg doses separated by 6 weeks. A maintenance dose of 500 mg may also be provided at 12, 24, and 36 weeks based on serum ferritin levels and transferrin saturation value.

The HEART-FID trial, presented at the European Society of Cardiology (ESC) Congress 2023, demonstrated that adults with HF who received Injectafer had a reduction in deaths and HF hospitalizations at 12 months compared to those who received a placebo. The trial also showed a small improvement in the 6-minute walking distance at 6 months.

While the trial did not meet the prespecified significance level, the overall body of evidence supports the use of Injectafer in aiding patients with HF and iron deficiency. Previous studies have also highlighted the improved quality of life and exercise capacity of this patient population after receiving IV ferric carboxymaltose.

Additional research has shown significant improvements in fatigue symptoms, physical function, and global health in patients treated with Injectafer. The benefits were mostly achieved after a single course of treatment, with only a small proportion of patients requiring additional intravenous iron treatment throughout the study period.

These findings suggest that Injectafer can be used in patients with iron deficiency following an acute HF episode to improve clinical outcomes and quality of life. The high frequency of iron deficiency and diabetes in AHF patients highlights the need for timely screening and treatment.

Injectafer’s approval by the FDA provides healthcare professionals with an effective tool to help patients with HF and iron deficiency. It also opens up new possibilities for improving patient outcomes and quality of life in 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.

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