Ferumoxytol
Generic Name: ferumoxytol
Brand Names:
Ferabright
11 DESCRIPTION FERABRIGHT (ferumoxytol injection) is an iron-based contrast agent for intravenous use. Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size ranges from 31 nm to 43 nm in diameter. The chemical formula of ferumoxytol is Fe 5874 O 8752 -C 11719 H 18682 O 9933 Na 414 with an apparent molecular weight of 750 kDa.
Overview
11 DESCRIPTION FERABRIGHT (ferumoxytol injection) is an iron-based contrast agent for intravenous use. Ferumoxytol is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size ranges from 31 nm to 43 nm in diameter. The chemical formula of ferumoxytol is Fe 5874 O 8752 -C 11719 H 18682 O 9933 Na 414 with an apparent molecular weight of 750 kDa.
Uses
1 INDICATIONS 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. FERABRIGHT is an iron-based contrast agent 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.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of FERABRIGHT is based on patient weight: 50 kg or less: 300 mg of elemental iron administered as a single intravenous infusion over at least 15 minutes. 51 kg or more: 510 mg of elemental iron administered as a single intravenous infusion over at least 15 minutes. ( 2.1 ) FERABRIGHT must be diluted before administration in either 0.9% sodium chloride injection or 5% dextrose injection to achieve concentrations of 2 mg/mL to 8 mg/mL of elemental iron. ( 2.2 ) Obtain post-contrast T1-weighted images approximately 24 hours after administration.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
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. 5 WARNINGS AND PRECAUTIONS Hypotension: Monitor for signs and symptoms of hypotension following administration. ( 5.2 ) Iron Overload: Avoid use of FERABRIGHT in patients with iron overload. ( 5.3 ) Magnetic Resonance Imaging Test Interference: Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT or use T1- or proton density-weighted pulse sequences if MRI is required within 3 months after administration. ( 5.4 ) Differences in Magnetic Resonance Imaging Appearance Compared to Gadolinium-Based Contrast: Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with FERABRIGHT. 4 CONTRAINDICATIONS 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 [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products ( 4 )
Pregnancy
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 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.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied FERABRIGHT (ferumoxytol injection) is a black to reddish brown, sterile aqueous solution available as: Total Amount per Total Volume (Concentration) Package Type Vials per Carton NDC 300 mg elemental iron per 10 mL (30 mg/mL) Single-Dose Vial One 24338-310-10 510 mg elemental iron per 17 mL (30 mg/mL) Single-Dose Vial One 24338-510-17 Storage and H...
Frequently Asked Questions
What is Ferumoxytol used for?▼
1 INDICATIONS 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. FERABRIGHT is an iron-based contrast agent 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.
What are the side effects of Ferumoxytol?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Ferumoxytol during pregnancy?▼
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 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.
What are the important warnings for 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. 5 WARNINGS AND PRECAUTIONS Hypotension: Monitor for signs and symptoms of hypotension following administration. ( 5.2 ) Iron Overload: Avoid use of FERABRIGHT in patients with iron overload. ( 5.3 ) Magnetic Resonance Imaging Test Interference: Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT or use T1- or proton density-weighted pulse sequences if MRI is required within 3 months after administration. ( 5.4 ) Differences in Magnetic Resonance Imaging Appearance Compared to Gadolinium-Based Contrast: Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with FERABRIGHT. 4 CONTRAINDICATIONS 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 [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.