Feraheme 510 mg/17mL
ferumoxytol · INJECTION · AMAG Pharmaceuticals, Inc.
Feraheme is a injection containing ferumoxytol at 510 mg/17mL, taken intravenous. Manufactured by AMAG Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Feraheme
- Generic Name
- ferumoxytol
- NDC Code (Product)
59338-775- Manufacturer
- AMAG Pharmaceuticals, Inc.
- Strength
- 510 mg/17mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA022180
- Drug Class
- Parenteral Iron Replacement [EPC]
- Marketing Start
- 07/13/2009
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 Feraheme 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). Feraheme 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 Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Administer Feraheme as an intravenous infusion in 50-200 mL 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP over at least 15 minutes. Take measures to avoid extravasation, as this can lead to skin discoloration or staining, which may be long lasting. If extravasation occurs, discontinue Feraheme administration at that site. Administer while the patient is in a reclined or semi-reclined position. Feraheme does not contain antimicrobial preservatives. Discard unused portion. Feraheme, when added to intravenous infusion bags containing either 0.9% Sodium Chloride Injection, USP (normal saline), or 5% Dextrose Injection, USP, at concentrations of 2-8 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 (2-8° C) for up to 48 hours. The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) a…
Contraindications
4 CONTRAINDICATIONS Feraheme is contraindicated in patients with: • Known hypersensitivity to Feraheme 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 Feraheme 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 Feraheme were not conducted. Feraheme 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 Feraheme, contact AMAG Pharmaceuticals, Inc. at 1-877-411-2510, 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 Feraheme. 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 Feraheme in 997 pa…
Frequently Asked Questions
What is Feraheme used for?
Feraheme contains ferumoxytol. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Feraheme a controlled substance?
Feraheme is not classified as a controlled substance by the DEA.
What is the generic name for Feraheme?
The generic name for Feraheme is ferumoxytol. There are 3 other brand versions of ferumoxytol.
What is the NDC code for Feraheme 510 mg/17mL?
The NDC (National Drug Code) for Feraheme 510 mg/17mL is 59338-775, listed by AMAG Pharmaceuticals, Inc..