Generic Name
Ferumoxytol
Brand Names
FeraBright, Feraheme
FDA approval date: July 13, 2009
Classification: Parenteral Iron Replacement
Form: Injection
What is FeraBright (Ferumoxytol)?
FERABRIGHT is indicated for magnetic resonance imaging of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier. FERABRIGHT is an iron-based contrast agent indicated for magnetic resonance imaging of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
Approved To Treat
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Brand Information
FeraBright (Ferumoxytol)
WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS
Fatal and serious hypersensitivity reactions, including anaphylaxis, have occurred in patients receiving ferumoxytol products that contain the same active ingredient as FERABRIGHT. Initial signs may include hypotension, syncope, unresponsiveness, and cardiac/cardiorespiratory arrest. Hypersensitivity reactions have occurred even in patients who previously tolerated ferumoxytol.
- Only administer FERABRIGHT 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.
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following FERABRIGHT infusion including monitoring of blood pressure and pulse during and after FERABRIGHT administration
1INDICATIONS AND USAGE
FERABRIGHT is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted blood-brain barrier.
2DOSAGE FORMS AND STRENGTHS
Injection: Black to reddish brown sterile aqueous solution available as:
- 300 mg elemental iron per 10 mL (30 mg/mL) in single-dose vials
- 510 mg elemental iron per 17 mL (30 mg/mL) in single-dose vials
3CONTRAINDICATIONS
FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products. Reactions have included anaphylaxis
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Anaphylaxis and Other Serious Hypersensitivity Reactions
- Hypotension
4.1Clinical 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.
Additional adverse reactions reported in Studies 002 and 003 were back pain (3 patients), vomiting (1 patient), and increased ALT (1 patient).
Additional adverse reactions reported in ≥1% of patients with IDA (FERABRIGHT is not approved to treat IDA) in a randomized clinical trial that administered two doses of 510 mg ferumoxytol 3 to 8 days apart by intravenous infusion (not an approved dosing regimen for FERABRIGHT) were dizziness and fatigue.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ferumoxytol products, which contain the same active ingredient as FERABRIGHT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5OVERDOSAGE
Excessive dosages of FERABRIGHT may lead to accumulation of iron in storage sites potentially leading to hemosiderosis
6DESCRIPTION
FERABRIGHT (ferumoxytol injection) is an iron-based contrast agent for intravenous use.
7CLINICAL STUDIES
The effectiveness of FERABRIGHT for intra-axial malignant brain lesion visualization was evaluated in a blinded read study of MRIs acquired from one open-label, intra-patient controlled clinical trial. The trial enrolled adult patients with known or suspected primary and secondary intra-axial neoplasms in the brain. Each patient received MRI before and after intravenous administration of an approved gadolinium-based contrast agent. Within seven days, MRI was performed before and after administration of a single dose of FERABRIGHT. Images from a total of 153 patients with known or suspected primary and secondary malignant intra-axial neoplasms in the brain who received approximately 510 mg of FERABRIGHT were analyzed in the blinded read study.
Table 2: Patient-Level Lesion Visualization Scores by Reader for Combined and Pre-Contrast MRI in Patients Receiving FERABRIGHT
FERABRIGHT lesion visualization scores and number of lesions visualized per patient were similar to those of comparator gadolinium-based contrast agents. In a side-by-side comparison of post-contrast T1-weighted images, some patients were rated as having larger or smaller size, greater or lesser intensity, and different pattern of lesion contrast between FERABRIGHT and gadolinium-based contrast
8HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
FERABRIGHT (ferumoxytol injection) is a black to reddish brown, sterile aqueous solution available as:
FERABRIGHT (ferumoxytol injection) is a black to reddish brown, sterile aqueous solution available as:
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Do not freeze.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
10Patient Package Insert
This Patient Information has been approved by the U.S. Food and Drug Administration. Approved: 10/2025
11PRINCIPAL DISPLAY PANEL – 10 mL
NDC 24338-310-10 Rx ONLYOne Single-Dose Vial – Discard Unused Portion
Ferabright
300 mg elemental iron per 10 mL (30 mg/mL)
FOR INTRAVENOUS USE AFTER DILUTION ONLY
NDC 24338-310-10 Rx ONLYSingle-Dose Vial – Discard Unused Portion
Ferabright
300 mg elemental iron per 10 mL (30 mg/mL)
FOR INTRAVENOUS USE AFTER DILUTION ONLY
12PRINCIPAL DISPLAY PANEL – 17 mL
NDC 24338-510-17 Rx ONLYOne Single-Dose Vial – Discard Unused Portion
Ferabright
510 mg elemental iron per 17 mL (30 mg/mL)
FOR INTRAVENOUS USE AFTER DILUTION ONLY
NDC 24338-510-17 Rx ONLYSingle-Dose Vial – Discard Unused Portion
Ferabright
510 mg elemental iron per 17 mL (30 mg/mL)
FOR INTRAVENOUS USE AFTER DILUTION ONLY
