Ferabright™
ferumoxytol injection
Important Safety Information
Please read this important safety information before prescribing or using Ferabright™
IMPORTANT SAFETY INFORMATION
Ferabright™ (ferumoxytol injection) 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.
This information does not replace the complete prescribing information. Healthcare professionals must consult the full prescribing information before use.
Contraindications
Known Hypersensitivity
Ferabright™ is contraindicated in patients with known hypersensitivity to ferumoxytol or any of its components.
Iron Overload
Use with caution in patients with iron overload conditions. Monitor iron parameters as appropriate.
Warnings and Precautions
Hypersensitivity Reactions
• Monitor patients for signs and symptoms of hypersensitivity during and after administration
• Have personnel and therapies readily available for treatment of serious hypersensitivity reactions
• Consider premedication in patients with history of drug allergies
• Delayed reactions may occur up to 30 minutes or more after administration
Iron Parameters
• May alter iron parameters for up to 3 months following administration
• Consider timing of iron studies relative to Ferabright™ administration
• Use alternative methods to assess iron status if necessary
MRI Interference
• May interfere with MRI for up to 3 months after administration
• Consider timing of non-contrast MRI studies relative to Ferabright™ administration
• Inform MRI technologists and radiologists of prior Ferabright™ administration
Adverse Reactions
Most Common Adverse Reactions
Common (≥2% of patients)
- • Nausea
- • Dizziness
- • Headache
- • Injection site reactions
- • Fatigue
Less Common (<2% of patients)
- • Hypersensitivity reactions
- • Chest discomfort
- • Back pain
- • Flushing
- • Dyspnea
Note: This is not a complete list of adverse reactions. Please refer to the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Drug Interactions
Oral Iron Products
Ferabright™ may reduce the absorption of concomitantly administered oral iron products. Consider timing of oral iron administration relative to Ferabright™.
Laboratory Tests
May interfere with laboratory tests and imaging studies. Consult with laboratory and imaging personnel regarding potential interference.
Use in Specific Populations
Pregnancy
There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and potential benefit justifies potential risk.
Lactation
It is not known if Ferabright™ is present in human milk. Consider benefits and risks when administering to nursing women.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Ferabright™ is not approved for use in pediatric patients.
Administration Guidelines
Pre-administration
- • Assess patient history for hypersensitivity to iron products
- • Ensure appropriate monitoring equipment is available
- • Have resuscitation equipment readily accessible
- • Review current medications and timing of MRI studies
During Administration
- • Monitor patient for signs of hypersensitivity
- • Administer as directed in prescribing information
- • Ensure proper intravenous access
- • Follow institutional protocols for contrast administration
Post-administration
- • Monitor patient for delayed hypersensitivity reactions
- • Document administration time and any adverse events
- • Provide patient with information about potential MRI interference
- • Schedule appropriate follow-up as clinically indicated
Complete Prescribing Information
For complete prescribing information, including dosing guidelines, detailed safety information, and clinical study data, please contact our medical affairs team.
Request Complete InformationMedical Information Disclaimer
This website provides general information about Ferabright™ and is intended for healthcare professionals only. The information presented here is not intended to replace professional medical advice, diagnosis, or treatment. Healthcare professionals should consult the complete prescribing information before prescribing Ferabright™. Patients should consult their healthcare provider for medical advice about their condition and treatment options.
Ferabright™ is a trademark of Covis Pharma GmbH. Covis Pharma GmbH is a wholly owned subsidiary of Azurity Pharmaceuticals, Inc. This website is operated by 澳門五洲藥物國際貿易有限公司 under exclusive distribution rights for the Greater China region.