Ferabright™
ferumoxytol injection
Ferabright™ Product Information
Comprehensive information about the world's first FDA-approved iron-based MRI contrast agent for brain imaging applications
Revolutionary Iron-Based Technology
Active Ingredient
Ferumoxytol - Superparamagnetic iron oxide nanoparticles
Indication
MRI of the brain in adults with known or suspected malignant neoplasms to visualize lesions with disrupted blood-brain barrier
FDA Approval
Approved October 17, 2025 - First-in-class designation
Indication
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.
Key Product Features
🥇 First-in-Class Technology
- • Global first and only FDA-approved iron-based MRI contrast agent
- • Superparamagnetic iron oxide nanoparticles (SPIO)
- • High relaxivity for enhanced imaging sensitivity
- • Revolutionary alternative to gadolinium-based contrast agents
🎯 Superior Imaging Performance
- • Precise visualization of blood-brain barrier disruption
- • Enhanced detection of glioma margins
- • Superior identification of brain metastases
- • Improved visualization of micro lesions
⏰ Extended Imaging Window
- • Longer imaging timeframe for flexible MRI protocols
- • Allows delayed scanning capabilities
- • Enables segmented acquisition sequences
- • Provides more sequence selection options
💊 Safety Profile
- • Safe for patients with renal dysfunction
- • Cleared via natural iron metabolism pathway
- • Reduced concerns about heavy metal accumulation
- • Alternative for gadolinium-contraindicated patients
Mechanism of Action
Iron Nanoparticles
Superparamagnetic iron oxide nanoparticles create strong T2* effects on MRI imaging
BBB Penetration
Particles accumulate in areas where blood-brain barrier integrity is compromised
Enhanced Contrast
Creates distinctive signal changes allowing precise tumor boundary visualization
Ferabright™ vs Traditional Contrast Agents
| Feature | Ferabright™ | Gadolinium Agents |
|---|---|---|
| Base Material | Iron-based nanoparticles | Gadolinium compounds |
| Kidney Safety | ✅ Safe for renal impairment | ❌ Contraindicated in severe CKD |
| Imaging Window | Extended (longer duration) | Standard (shorter window) |
| BBB Disruption Detection | ✅ Superior sensitivity | Standard detection |
| Clearance | Natural iron metabolism | Renal elimination |
| Long-term Accumulation | ✅ Minimal concern | ⚠️ Potential brain deposition |
Dosage & Administration
Recommended Dosage
Please refer to the official prescribing information for complete dosing guidelines, contraindications, and safety information.
Important Notice
This website provides general product information only. Healthcare professionals should consult the complete prescribing information before use. For detailed clinical protocols and dosing recommendations, please contact our medical affairs team.