FDA approved Feraheme (ferumoxytol) for Iron Deficiency Anemia in AdultsFDA approved new iron drug Feraheme for adults with anemia.

FDA From the archive Source published June 30, 2009 Summary added June 2, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider Feraheme for IDA patients intolerant to oral iron or with CKD; two 510 mg IV doses 3-8 days apart.

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)

Mechanism of Action

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.

Indication & Patient Population

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).

Dosing & Administration

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.

Key Clinical Trial Data

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).

Warnings & Contraindications

Not reported in label.

Place in Therapy

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.

The FDA has approved a new drug called Feraheme (ferumoxytol) for adults with iron deficiency anemia. This condition happens when your body does not have enough iron to make healthy red blood cells. Feraheme is given through a vein (intravenously) as two separate infusions, usually 3 to 8 days apart. Each infusion takes at least 15 minutes.

This drug is for adults who cannot take iron pills because of side effects or because the pills did not work well enough. It is also for people with chronic kidney disease who often have trouble with oral iron. In clinical studies, 81% of patients who got Feraheme had a significant increase in hemoglobin (a key blood protein) within 5 weeks, compared to only 5.5% in the placebo group.

The approval means there is now a new option for patients who need iron but cannot use pills. However, like all medicines, Feraheme has risks. Some patients may have low blood pressure or allergic reactions during or after the infusion. Your doctor will monitor you closely.

If you think this drug might be right for you, talk to your doctor. They can help decide if Feraheme is a good choice based on your health history and needs. This is not a recommendation to ask for this drug, but a reminder to have an open conversation with your healthcare provider.

What this means for you:

Feraheme is a new IV iron option for adults who cannot take iron pills, but talk to your doctor to see if it is right for you.

Study Details

Study typeFda approval

PublishedJun 2009

View Original Abstract ↓

1 INDICATIONS AND USAGE 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). Feraheme is an iron replacement product 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 ( 1 ) or • who have chronic kidney disease (CKD). ( 1 )

FDA approved Feraheme (ferumoxytol) for Iron Deficiency Anemia in AdultsFDA approved new iron drug Feraheme for adults with anemia.

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