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Feraheme (FERUMOXYTOL)
Feraheme delivers iron to macrophages where it is released and either stored or transported to erythroid precursor cells.
Feraheme (ferumoxytol) is a parenteral iron replacement therapy developed by AMAG PHARMS INC and currently owned by Covis. It is a small molecule used to treat iron deficiency anemia. Feraheme was FDA approved in 2009 and is now off-patent, with a generic manufacturer available. It has a half-life of 15 hours. Key safety considerations include potential allergic reactions and iron overload.
At a glance
| Generic name | FERUMOXYTOL |
|---|---|
| Sponsor | Covis |
| Drug class | Parenteral Iron Replacement [EPC] |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
Feraheme is a superparamagnetic iron oxide coated with a carbohydrate shell. This coating isolates the iron from plasma until it reaches macrophages in the liver, spleen, and bone marrow. Once inside these cells, the iron is released and can be used for hemoglobin synthesis or stored.
Approved indications
- Iron deficiency anemia
Boxed warnings
- WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • 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. [ see Warnings and Precautions (5.1) ]. • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration [ see Warnings and Precautions (5.1) ]. • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [ see Warnings and Precautions (5.1) ]. WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS See full prescribing information for complete boxed warning . Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • 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. ( 5.1 ) • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration. ( 5.1 ) • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. ( 5.1 )
Common side effects
- Headache
- Nausea
- Dizziness
- Fatigue
- Diarrhea
- Back Pain
Key clinical trials
- In Vivo Characterization of Inflammation With Ferumoxytol, an Ultrasmall Superparamagnetic Iron Oxide Nanoparticle, on 7 Tesla Magnetic Resonance Imaging (PHASE1)
- Ferumoxytol-enhanced Magnetic Resonance Venography in Patients With Venous Diseases (PHASE2)
- Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients (PHASE3)
- Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis
- Gadolinium and Ferumoxytol MRI in Diagnosing Patients With Abnormalities in the Central Nervous System (PHASE2)
- Effectiveness of Topical Magnetite Zinc Oxide Composite Nanoparticles in the Management of Oral Potentially Malignant Lesions (EARLY_PHASE1)
- A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
- Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Feraheme CI brief — competitive landscape report
- Feraheme updates RSS · CI watch RSS
- Covis portfolio CI