ferabright
Pharmaranks rates Ferabright 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Ferabright (Ferumoxytol) is a parenteral iron replacement used to treat Iron-Deficiency Anemia.
Ferumoxytol · by Azurity
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Ferumoxytol
- Drug class
- Parenteral Iron Replacement
- Form
- Injectable
- Strength
- Ferumoxytol EQ 300MG IRON/10ML (EQ 30MG IRON/ML) · Ferumoxytol EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- iron-deficiency anemia
- Manufacturer
- Azurity
- FDA application
- NDA219868
- FDA boxed warning
- Yes — see the boxed warning
What is Ferabright?
From the FDA label: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.
How to use
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 ) 2.1 Recommended 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.,…
Side effects
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. 6.1 Clinical 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…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 )
Warnings
Important safety information
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 ) 5.1 Anaphylaxis 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 )] . 5.2 Hypotension FERABRIGHT may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following FERABRIGHT administration [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 )] . In a clinical study in patients with IDA (FERABRIGHT is not approved to treat IDA), moderate hypotension was reported in 0.2% (2/997) of patients administered ferumoxytol as an intravenous infusion over 15 minutes. In clinical studies in patients with IDA and CKD (FERABRIGHT is not approved to treat IDA or CKD), hypotension was reported in 1.9% (35/1,806) of patients, including three patients with serious hypotensive reactions, who were administered ferumoxytol as a rapid intravenous injection (not an approved method of administration for FERABRIGHT). Hypotension has also been reported in postmarketing experience [see Adverse Reactions ( 6.2 )] . 5.3 Iron overload Use of FERABRIGHT can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Avoid use of FERABRIGHT in patients with iron overload. 5.4 Magnetic Resonance Imaging Test Interference Administration of FERABRIGHT may transiently affect the diagnostic ability of MRI. Conduct anticipated MRI studies (other than the intended FERABRIGHT brain imaging) prior to the administration of FERABRIGHT. Alteration of MRI studies may persist for up to 3 months following the FERABRIGHT dose. If MRI is required within 3 months after FERABRIGHT administration, use T1- or proton density-weighted pulse sequences to minimize the FERABRIGHT effects. MRI imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of FERABRIGHT. Maximum alteration of vascular MRI signal is evident for 1 to 2 days following FERABRIGHT administration [see Clinical Pharmacology ( 12.3 )] . FERABRIGHT will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), planar nuclear medicine imaging, or ultrasound. 5.5 Differences in Magnetic Resonance Imaging Appearance Compared to Gadolinium-Based Contrast MRI obtained with FERABRIGHT may demonstrate different size, intensity, and pattern of contrast signal in lesions compared to images obtained with gadolinium-based contrast [see Clinical Studies ( 14 )] . Be aware of the potentially limited interpretability of changes in lesion contrast appearance if prior images were not obtained with FERABRIGHT.
Who should not take Ferabright
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 )
Overdose — what happens if you take too much
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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Storing Ferabright, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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.”
Drug class
How this class works, per Iron Dextran - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Ferabright ranks — best-rated parenteral iron replacement for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
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Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Ferabright treat?
- Ferabright (Ferumoxytol) may be used to treat iron-deficiency anemia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Ferabright work?
- Ferabright is a parenteral iron replacement. Given by injection or IV, these supply iron directly into the bloodstream wrapped in a protective carbohydrate shell. The iron is gradually released, picked up by the protein transferrin, and delivered to the bone marrow, where it is used to build hemoglobin and treat iron-deficiency anemia.
- How is Ferabright rated?
- pharmaranks gives Ferabright a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Ferabright?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Ferabright. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Ferabright?
- Ferabright is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Ferabright a brand-name or generic drug?
- Ferabright is a brand-name product with the active ingredient Ferumoxytol.
- Is Ferabright available over the counter?
- No. Ferabright is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Ferabright come in?
- Ferabright is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Ferabright?
- Ferabright is classified as parenteral iron replacement, per the FDA's Established Pharmacologic Class.
- Is Ferabright FDA-registered?
- Ferabright is on record with the U.S. FDA under application number NDA219868. You can verify this on its official FDA label.
- Has Ferabright been recalled by the FDA?
- Ferabright has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Ferabright safe?
- There's no single safe-or-not verdict. pharmaranks gives Ferabright a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Ferabright?
- Ferabright's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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ferabright
70/100