Ferumoxytol 510 mg/17mL
ferumoxytol · INJECTION · Sandoz Inc
Ferumoxytol is a injection containing ferumoxytol at 510 mg/17mL, taken intravenous. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Ferumoxytol
- Generic Name
- ferumoxytol
- NDC Code (Product)
0781-3154- Manufacturer
- Sandoz Inc
- Strength
- 510 mg/17mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA206604
- Drug Class
- Parenteral Iron Replacement [EPC]
- Marketing Start
- 07/15/2021
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron ( 1 ) or • who have chronic kidney disease (CKD). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of ferumoxytol injection is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer ferumoxytol as an intravenous infusion in 50 to 200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Administer while the patient is in a reclined or semi-reclined position. Ferumoxytol injection does not contain antimicrobial preservatives. Discard unused portion. Ferumoxytol injection, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2 to 8 mg elemental iron per mL, should be used immediately but may be stored at controlled room temperature (25°C ± 2°C) for up to 4 hours or refrigerated (2 to 8° C) for up to 48 hours The dosage is expressed in terms of mg of elemental iron, with each mL of ferumoxytol containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second ferumoxytol infusion. The recommended ferumoxytol injection dose may be readministered to patients w…
Contraindications
4 CONTRAINDICATIONS Ferumoxytol is contraindicated in patients with: • Known hypersensitivity to ferumoxytol or any of its components [see Warnings and Precautions ( 5.1 )] . • History of allergic reaction to any intravenous iron product [see Warnings and Precautions ( 5.1 )] . • Known hypersensitivity to ferumoxytol or any of its components. ( 4 ) • History of allergic reaction to any intravenous iron product. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Drug-drug interaction studies with ferumoxytol were not conducted. Ferumoxytol may reduce the absorption of concomitantly administered oral iron preparations.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Hypotension [see Warnings and Precautions ( 5.2 )] • Iron Overload [see Warnings and Precautions ( 5.3 )] • Magnetic Resonance (MR) Imaging Test Interference [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema. (6.1) To report SUSPECTED ADVERSE REACTIONS with ferumoxytol injection, contact Sandoz Inc., at 1-800-525-8747, 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. In clinical studies, 3,968 subjects were exposed to ferumoxytol. Of these subjects 31% were male and the median age was 54 years (range of 18 to 96 years). The data described below reflect exposure to ferumoxytol in 997 …
Frequently Asked Questions
What is Ferumoxytol used for?
Ferumoxytol contains ferumoxytol. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Ferumoxytol a controlled substance?
Ferumoxytol is not classified as a controlled substance by the DEA.
What is the generic name for Ferumoxytol?
The generic name for Ferumoxytol is ferumoxytol. There are 3 other brand versions of ferumoxytol.
What is the NDC code for Ferumoxytol 510 mg/17mL?
The NDC (National Drug Code) for Ferumoxytol 510 mg/17mL is 0781-3154, listed by Sandoz Inc.