Ferumoxytol

Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages.

• 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).ICD-10: D64.9, E61.1, N18.9

• Feraheme is contraindicated in patients with: • Known hypersensitivity to Feraheme or any of its components [see Warnings and Precautions ( 5.1 )] • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] • Known hypersensitivity to Feraheme or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product.contraindicated

The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Take measures to avoid extravasation, as this can lead to skin discoloration or staining, which may be long lasting. If extravasation occurs, discontinue Feraheme administration at that site. Administer while the patient is in a reclined or semi-reclined position. Feraheme does not contain antimicrobial preservatives. Discard unused portion. Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2-8° C) for up to 48 hours. The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme infusion. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia. For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme infusion.

• Greater risk of anaphylaxis in patients with multiple drug allergies. ( 5.1 ) • Hypotension: Feraheme may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of Feraheme. ( 5.2 ) • Iron Overload: Regularly monitor hematologic responses during Feraheme therapy. Do not administer Feraheme to patients with iron overload. ( 5.3 ) • Magnetic Resonance Imaging Test Interference: Feraheme can alter magnetic resonance imaging (MRI) studies. ( 5.4 ) 5.1 Serious Hypersensitivity Reactions Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Iron Overload [see Warnings and Precautions ( 5.3 )] • Magnetic Resonance (MR) Imaging Test Interference [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS with Feraheme, contact AMAG Pharmaceuticals, Inc. at 1-877-411-2510, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical studies, 3,968 subjects were exposed to Feraheme. Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years). The data described below reflect exposure to Feraheme in 997 patients exposed to a 1.02 g course of ferumoxytol administered as two 510 mg intravenous (IV) doses: 992 subjects (99.5%) received at least 1 complete dose of ferumoxytol and 946 subjects (94.9%) received 2 complete doses. The mean cumulative IV Iron exposure was 993.80 ±119.085 mg.

8.1 Pregnancy Risk Summary Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy as well as risks to the fetus associated with maternal severe hypersensitivity reactions ( see Clinical Considerations ). In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

Metabolism

The pharmacokinetic (PK) behavior of Feraheme has been examined in healthy subjects and in patients with CKD stage 5D on hemodialysis. Feraheme exhibited dose-dependent, capacity-limited elimination from plasma with a half-life of approximately 15 hours in humans.

Limited data are available regarding overdosage of Feraheme in humans. Excessive dosages of Feraheme may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Feraheme to patients with iron overload [Warnings and Precautions ( 5.3 )]. Feraheme is not removed by hemodialysis. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

• Jun 30, 2009NDANDA022180Azurity
• Jan 15, 2021ANDAANDA206604Sandoz
• Oct 16, 2025NDANDA219868Azurity

1. 1Dyspnoea46024%
2. 2Nausea23813%
3. 3Flushing22812%
4. 4Back Pain20811%
5. 5Hypotension20411%
6. 6Infusion Related Reaction20111%
7. 7Anaphylactic Reaction1839.7%
8. 8Dizziness1799.5%
9. 9Chest Discomfort1719.0%
10. 10Hypersensitivity1507.9%
11. 11Unresponsive To Stimuli1397.4%
12. 12Chest Pain1377.2%
13. 13Vomiting1357.1%
14. 14Hyperhidrosis1085.7%
15. 15Pruritus975.1%

Recent PubMed references pinned to Ferumoxytol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Research Progress of Ferrosoferric Oxide Nanoparticles in Bone Regeneration and Disease Treatment.
  International journal of nanomedicine · 2026 · Song JB, Li JY, Ding YB, et al.
  PMID 42205869DOI 10.2147/IJN.S570169
• Ferumoxytol-Enhanced Myocardial T1 Tracking Using a Hybrid 2D/3D Steady-State MRI Sequence Captures Cyclic Intramyocardial Blood Volume Dynamics.
  NMR in biomedicine · 2026 · Unal HB, Zeynali S, Ahmed A, et al.
  PMID 42152464DOI 10.1002/nbm.70308
• Magnetite-mediated microbial community succession enhances methanogenic degradation of benzoate under stepwise salinity stress.
  Bioresource technology · 2026 · Jung S, Song M, Kim M, et al.
  PMID 42128240DOI 10.1016/j.biortech.2026.134871
• Phased impact of Fe(3)O(4)-modified volcanic rock on methanogenesis treating real municipal wastewater under ambient temperature: From electron competition to enhanced methane production.
  Environmental research · 2026 · Zhang S, Liu X, Cheng R, et al.
  PMID 42107824DOI 10.1016/j.envres.2026.124665
• Effects of magnetite- and attapulgite-modified biochar with organic fertiliser: mineral-driven microbial mechanisms regulating the nitrogen cycle.
  Environmental technology · 2026 · Yao Y, Cheng Q, Zhou H, et al.
  PMID 42083940DOI 10.1080/09593330.2026.2656823
• Mechanism of magnetite coupled microbial enhancement in mariculture wastewater treatment: Dual edged role of magnetite.
  Bioresource technology · 2026 · Zong K, Zhang T, Li Y, et al.
  PMID 42067165DOI 10.1016/j.biortech.2026.134749
• Controlled Low-Oxygen Supply Enables Magnetosome Size Tuning by Uncoupling Magnetite Nucleation and Crystal Growth in Magnetospirillum gryphiswaldense.
  Microbial biotechnology · 2026 · Tessaro S, Schüritz M, Jérôme V, et al.
  PMID 41978945DOI 10.1111/1751-7915.70349
• Tunable dendritic Fe(3)O(4)@mSiO(2)-Ni(2+) core-shell magnetic nanospheres for selective enrichment of histidine-rich proteins.
  Talanta · 2026 · Chen X, Nie Y, Zhao Z, et al.
  PMID 41962442DOI 10.1016/j.talanta.2026.129774

The 10 most recently updated of 122 ClinicalTrials.gov registrations naming Ferumoxytol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Hearts on Fire: Targeting Inflammation in Heart Failure With Preserved Ejection Fraction
  Recruiting · Early phase 1 · Interventional · 70 enrolled · University of Florida
  NCT07634640updated 2026-06-09
• In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging
  Completed · Phase 1 · Interventional · 14 enrolled · National Institute of Neurological Disorders and Stroke (NINDS)
  NCT02511028updated 2026-06-08
• Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants
  Recruiting · Phase 2 · Interventional · 120 enrolled · University of Washington
  NCT05340465updated 2026-05-26
• Handheld MPI Imaging to Track Stem Cells in Osteoarthritis
  Enrolling by invitation · Early phase 1 · Interventional · 10 enrolled · Soochow University
  NCT07313020updated 2026-05-12
• Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
  Recruiting · Phase 2 · Interventional · 50 enrolled · University of Alberta
  NCT06483061updated 2026-05-08
• A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
  Recruiting · Phase 3 · Interventional · 75 enrolled · AMAG Pharmaceuticals, Inc.
  NCT03893045updated 2026-04-17
• A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
  Recruiting · Phase 3 · Interventional · 129 enrolled · AMAG Pharmaceuticals, Inc.
  NCT03619850updated 2026-04-17
• Magnetic Resonance Angiography for Peripheral Arterial Disease (PAD)
  Completed · Phase 2 · Interventional · 119 enrolled · AMAG Pharmaceuticals, Inc.
  NCT00707876updated 2026-04-16
• Nanozymes in Endodontics
  Not yet recruiting · Phase 4 · Interventional · 72 enrolled · University of Pennsylvania
  NCT07518901updated 2026-04-09
• Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
  Recruiting · Observational · 146 enrolled · University of Wisconsin, Madison
  NCT04867954updated 2026-04-09

Frequently asked questions

How does Ferumoxytol work?

Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages.

What is Ferumoxytol used for?

According to FDA labeling, Ferumoxytol carries indications including: 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).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ferumoxytol?

Ferumoxytol is classified as Parenteral Iron Replacement, Electrolyte Activity, Increased Hematopoiesis.

What are the brand names for Ferumoxytol?

Ferumoxytol is marketed under brand names including Feraheme.

What are the contraindications for Ferumoxytol?

Ferumoxytol labeling lists contraindications including: Feraheme is contraindicated in patients with: • Known hypersensitivity to Feraheme or any of its components [see Warnings and Precautions ( 5.1 )] • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] • Known hypersensitivity to Feraheme or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product.. Always consult the full prescribing information and a clinician.