FDA Approves Feraheme (ferumoxytol) for Iron Deficiency Anemia in Adults
The FDA has approved Feraheme (ferumoxytol) for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have chronic kidney disease (CKD). Feraheme is an intravenous iron replacement product that provides an alternative for patients who cannot use oral iron therapy. The approval was based on clinical trials demonstrating efficacy in raising hemoglobin levels. In one trial, 81% of Feraheme-treated patients achieved a hemoglobin increase of at least 2 g/dL from baseline to week 5, compared with 5.5% in the placebo group. The recommended dosing regimen is two 510 mg intravenous infusions administered 3 to 8 days apart, each infused over at least 15 minutes. Clinicians should monitor patients for hypotension and hypersensitivity reactions during and after infusion.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Feraheme is an iron replacement product. Ferumoxytol is a superparamagnetic iron oxide nanoparticle that provides a source of elemental iron for hemoglobin synthesis and replenishes iron stores.
Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron, or who have chronic kidney disease (CKD).
The recommended dose is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position. Evaluate hematologic response (hemoglobin, ferritin, iron, transferrin saturation) at least one month after the second infusion. The dose may be readministered for persistent or recurrent IDA. For hemodialysis patients, administer once blood pressure is stable and after at least one hour of dialysis. Monitor for hypotension after each infusion. Allow at least 30 minutes between Feraheme and other medications that could cause serious hypersensitivity or hypotension.
Efficacy was assessed in two randomized controlled trials (IDA Trial 1 and IDA Trial 2) in patients with IDA and a history of unsatisfactory oral iron therapy or inability to use oral iron. In IDA Trial 1 (Feraheme vs placebo), 81.1% of Feraheme patients had a hemoglobin increase of ≥2 g/dL from baseline to week 5 vs 5.5% for placebo (treatment difference 75.6%, p≤0.001). Mean hemoglobin change was +2.6 g/dL vs +0.1 g/dL. In IDA Trial 2 (Feraheme vs iron sucrose), 84.0% vs 81.4% achieved ≥2 g/dL increase (treatment difference 2.6%, 95% CI -3.9 to 9.1). Mean hemoglobin change was +2.9 vs +2.7 g/dL. In IDA Trial 1, Feraheme patients reported greater improvement in FACIT-Fatigue score (+11.7 points) vs placebo (+6.8 points), difference 4.9 points (95% CI 3.08-6.71).
Not reported in label.
Feraheme is an intravenous iron option for adult patients with iron deficiency anemia who cannot tolerate or have inadequate response to oral iron, or who have chronic kidney disease. It offers a two-dose regimen administered as IV infusions.
View Original Abstract ↓
Systematic review confirms clip anastomosis improves one and two year primary patency rates for arteriovenous fistula creation compared to suture methods
Vascular Clips Outperform Sutures for Dialysis Access Longevity
Related in Nephrology
From Other Specialties
