FeraBright Ferumoxytol 30 mg/mL Injection
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🧪 Inactive Ingredients / Excipients
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
1 inactive ingredient listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| FeraBright 30 mg/mL 24338-0510-17 | Azurity | 1 vial | — | — | FDA listed | — |
| FeraBright 30 mg/mLthis 24338-0310-10 | Azurity | 1 vial | — | — | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Code | What it grants | Expires |
|---|---|---|
| NP | New Product | Oct 16, 2028 |
| NP | New Product | Oct 16, 2028 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 24338-0310-10 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-10-20 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 [see Warnings and Precautions ( 5.1 )] . 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. ( 5.1 )
🎯 Indications and Usage ▾
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 and Administration ▾
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. ( 2.3 )
2.1Recommended Dosage and Administration Instructions The recommended dose of FERABRIGHT is based on patient body weight as follows: 50 kg or less: 300 mg of elemental iron diluted in 0.9% sodium chloride injection or 5% dextrose injection [see Dosage and Administration ( 2.2 )] . 51 kg or more: 510 mg of elemental iron diluted in 0.9% sodium chloride injection or 5% dextrose injection [see Dosage and Administration ( 2.2 )]. Administer diluted FERABRIGHT by intravenous infusion over at least 15 minutes while the patient is in a reclined or semi-reclined position approximately 24 hours prior to imaging [see Clinical Pharmacology ( 12.1 )] .
Allow at least 30 minutes after FERABRIGHT infusion for administration of any other medications that may cause serious hypersensitivity reactions or hypotension (e.g., chemotherapeutic agents or monoclonal antibodies) [see Warnings and Precautions ( 5.1 , 5.2 )].
2.2Dilution Instructions To achieve a final concentration of 2 mg/mL to 8 mg/mL of elemental iron, add the recommended dose of FERABRIGHT to 0.9% sodium chloride injection or 5% dextrose injection as follows: For a 300 mg dose, add 10 mL of FERABRIGHT to 50 mL to 140 mL diluent. For a 510 mg dose, add 17 mL of FERABRIGHT to 50 mL to 200 mL diluent. Inspect diluted FERABRIGHT visually for the absence of particulate matter and discoloration prior to administration.
Use diluted FERABRIGHT solution immediately. If not used immediately, store the diluted FERABRIGHT solution at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2°C to 8°C) for up to 48 hours. Each vial of FERABRIGHT is for a single dose.
Discard any unused portion.
2.3Imaging Obtain post-contrast T1-weighted images approximately 24 hours after FERABRIGHT administration.
💊 Dosage Forms and Strengths ▾
3 DOSAGE 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 Injection: 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 ( 3 )
⛔ Contraindications ▾
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 )
⚠️ Warnings and Cautions ▾
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. ( 5.5 )
5.1Anaphylaxis and Other Serious Hypersensitivity Reactions Fatal and serious hypersensitivity reactions, including anaphylaxis presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness, have occurred in patients receiving ferumoxytol products, which contain the same active ingredient as FERABRIGHT. Other adverse reactions potentially associated with hypersensitivity have occurred, including pruritus, rash, urticaria, and wheezing. These reactions have occurred in patients who had no prior exposure to ferumoxytol as well as in patients who previously tolerated ferumoxytol.
Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with FERABRIGHT. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of ferumoxytol including FERABRIGHT may have more severe outcomes. Carefully consider the potential risks and benefits before administering FERABRIGHT to these patients.
FERABRIGHT is contraindicated in patients with known hypersensitivity to ferumoxytol, any of FERABRIGHT’s components, or any other intravenous iron products [see Contraindications ( 4 )] . 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. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after FERABRIGHT administration for at least 30 minutes and until clinically stable following completion of infusion.
Allow at least 30 minutes after FERABRIGHT infusion for administration of any other medications that may cause serious hypersensitivity reactions or hypotension [see Dosage and Administration ( 2.1 )] . In a clinical study in patients with iron deficiency anemia (IDA) (FERABRIGHT is not approved to treat IDA), regardless of etiology, hypersensitivity reactions were reported in 0.4% (4/997) of patients administered ferumoxytol as an intravenous infusion over at least 15 minutes. These included one patient with severe hypersensitivity reaction and three patients with moderate hypersensitivity reactions.
In clinical studies predominantly in patients with IDA and chronic kidney disease (CKD) (FERABRIGHT is not approved to treat IDA or CKD), serious hypersensitivity reactions were reported in 0.2% (4/1,806) of patients administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.5% (63/1,806) of these patients. In postmarketing experience with ferumoxytol, fatal and serious anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported [see Adverse Reactions ( 6.2 )] .
5.2Hypotension FERABRIGHT may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following FERABRIGHT administration [see Dosage and Adminis…
🤒 Adverse Reactions ▾
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.
6.1Clinical 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. The safety of FERABRIGHT was evaluated in three blinded read studies (Study 001, Study 002, and Study 003) in 225 patients with known or suspected neoplasms in the brain who received FERABRIGHT by intravenous infusion for MRI.
In Study 001, 153 patients weighing between 45 kg and 140 kg received a FERABRIGHT median dose of 506 mg [see Clinical Studies ( 14 )] . The 510 mg dose is recommended in patients weighing 51 kg or more [see Dosage and Administration ( 2.1 )] . The mean (range) age was 52 (18 to 83) years; patients were 57% male, 92% White, 2% Black or African American, 3% Asian, 1% American Indian or Alaska Native, 2% of other race, and 93% Not Hispanic or Latino ethnicity.
In Study 002, 17 patients weighing between 60 kg and 135 kg received a FERABRIGHT median dose of 435 mg. Doses below 510 mg are not recommended in patients weighing 51 kg or more [see Dosage and Administration ( 2.1 )] . The mean (range) age was 52 (32 to 72) years; patients were 65% male, 100% White, and 100% Not Hispanic or Latino ethnicity.
In Study 003, 55 patients weighing between 62 kg and 129 kg received a FERABRIGHT median dose of 312 mg. Doses below 510 mg are not recommended in patients weighing 51 kg or more [see Dosage and Administration ( 2.1 )] . The mean (range) age was 51 (23 to 73) years; patients were 64% male, 91% White, 4% Asian, 2% Native Hawaiian or Other Pacific Islander, 4% of other race, and 93% Not Hispanic or Latino ethnicity.
Adverse reactions reported in patients (≥0.65%) in Study 001 are shown in Table 1. Table 1: Adverse Reactions Reported in Brain Neoplasm Patients who Received FERABRIGHT for MRI in Study 001* *Median dose of 506 mg. The 510 mg dose is recommended in patients weighing 51 kg or more [see Dosage and Administration ( 2.1 )] .
Adverse Reaction FERABRIGHT (N = 153) n (%) Nausea Pruritus Constipation Headache Diarrhea Increased blood pressure Bleeding Hyperpigmentation Vein injury Taste alteration Burning/tingling sensation with injection Red sclera Allergic rhinitis 3 (1.96%) 2 (1.31%) 2 (1.31%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 1 (0.65%) 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.
Additional adverse reactions reported in ≥1% of patients with IDA and CKD (FERABRIGHT is not approved to treat IDA or CKD) in three randomized clinical trials that administered two doses of 510 mg ferumoxytol 3 to 8 days apart by rapid intravenous injection (not an approved dosing regimen for FERABRIGHT) were peripheral edema, edema, abdominal pain, cough, pyrexia, dyspnea, and muscle…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron products (such as FERABRIGHT), which may cause fetal bradycardia, especially during the second and third trimester. Data Animal Data Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects.
These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights. In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and soft tissue fetal malformations and decrease in fetal weights.
8.2Lactation Risk Summary There are no data on the presence of ferumoxytol in human milk, the effects on the breastfed child, or the effects on milk production. Ferumoxytol has been detected in the milk of lactating rats. However, due to species-specific differences in lactation physiology, the clinical relevance of these data is not clear.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FERABRIGHT and any potential adverse effects on the breastfed child from FERABRIGHT or from the underlying maternal condition.
8.4Pediatric Use The safety and effectiveness of FERABRIGHT in pediatric patients (less than 18 years old) have not been established.
8.5Geriatric Use Of the total number of patients administered FERABRIGHT in the brain MRI re-read studies, 40 (18%) were 65 years of age and older, and 8 (4%) were 75 years of age and older [see Adverse Reactions ( 6.1 )] . No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences between the elderly and younger patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of FERABRIGHT may have more severe outcomes.
In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions ( 5.1 )] .
🤰 Pregnancy ▾
8.1Pregnancy 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.
The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations Fetal/Neonatal adverse reactions Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant women with intravenous iron products (such as FERABRIGHT), which may cause fetal bradycardia, especially during the second and third trimester. Data Animal Data Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects.
These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights. In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and soft tissue fetal malformations and decrease in fetal weights.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of FERABRIGHT in pediatric patients (less than 18 years old) have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients administered FERABRIGHT in the brain MRI re-read studies, 40 (18%) were 65 years of age and older, and 8 (4%) were 75 years of age and older [see Adverse Reactions ( 6.1 )] . No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences between the elderly and younger patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of FERABRIGHT may have more severe outcomes.
In general, dose administration to an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions ( 5.1 )] .
🆘 Overdosage ▾
10 OVERDOSAGE Excessive dosages of FERABRIGHT may lead to accumulation of iron in storage sites potentially leading to hemosiderosis [see Warnings and Precautions ( 5.3 )]. Ferumoxytol is not removed by hemodialysis.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Ferumoxytol is a superparamagnetic iron oxide coated with a carbohydrate shell that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues on T1-weighted MRI. Disruption of the blood-brain barrier allows distribution of ferumoxytol into lesions such as neoplasms.
Since extravasation of the large ferumoxytol molecules is slow, parenchymal enhancement is seen in the delayed phase, approximately 24 hours post-administration of FERABRIGHT.
12.2Pharmacodynamics Ferumoxytol exposure-response relationships and the time course of pharmacodynamic response are unknown. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled, parallel-group study, healthy subjects received rapid intravenous injection of two 510 mg doses of ferumoxytol within 24 hours (not an approved dosing regimen for FERABRIGHT), placebo, or a single dose of 400 mg moxifloxacin (positive control). Results demonstrated no effect of ferumoxytol on QT interval durations.
No clinically meaningful effect of ferumoxytol on heart rate was observed.
12.3Pharmacokinetics Ferumoxytol maximum concentration (C max ) increases proportionally and area under the concentration-time curve (AUC) increases more than proportionally over a dose range from 1 mg/kg (70 mg in a patient with body weight of 70 kg- not an approved dosing regimen for FERABRIGHT) to 510 mg elemental iron. Rate of infusion ranging from 2 mL/min to 60 mL/min has no significant influence on pharmacokinetics (PK) of ferumoxytol. Distribution The volume of distribution is
3.4L. Elimination Ferumoxytol exhibits dose-dependent, capacity-limited elimination from plasma. Terminal half-life increases by increasing the dose of ferumoxytol.
Terminal half-life is approximately 21 hours after a single 510 mg elemental iron dose. Specific Populations Ferumoxytol clearance increases with body weight. There are no clinically significant differences in the PK of ferumoxytol based on age (18 to 77 years), sex, race (Black or White), or renal function (CLcr: 4.9 to 188 mL/min).
🧬 Mechanism of Action ▾
12.1Mechanism of Action Ferumoxytol is a superparamagnetic iron oxide coated with a carbohydrate shell that develops a magnetic moment when placed in a magnetic field. The magnetic moment alters the relaxation rates of water protons in its vicinity in the body, leading to an increase in signal intensity (brightness) of tissues on T1-weighted MRI. Disruption of the blood-brain barrier allows distribution of ferumoxytol into lesions such as neoplasms.
Since extravasation of the large ferumoxytol molecules is slow, parenchymal enhancement is seen in the delayed phase, approximately 24 hours post-administration of FERABRIGHT.
📦 How Supplied / Storage and Handling ▾
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 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.
📋 Description ▾
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. Each mL contains 30 mg of elemental iron and 30 mg of polyglucose sorbitol carboxymethylether as ferumoxytol, and 44 mg of mannitol. It contains no preservatives.
FERABRIGHT is a sterile, aqueous, black to reddish brown, isotonic colloidal solution with an osmolality of 270 mOsm/kg to 330 mOsm/kg, magnetic susceptibility of 27,250 to 39,000 x 10 -6 cgs/g Fe, and a pH of 6 to 8.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Anaphylaxis and Other Serious Hypersensitivity Reactions Inform patients of the risk of hypersensitivity reactions, including anaphylaxis. Discuss with patients regarding any prior history of allergies to intravenous iron products, and advise them to immediately report any symptoms of hypersensitivity that may develop during and following FERABRIGHT administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] .
Manufactured for: Azurity Pharmaceuticals, Inc. Woburn, MA 01801 USA