These highlights do not include all the information needed to use Feraheme safely and effectively. See full prescribing information for Feraheme.
Feraheme® (ferumoxytol) Injection
For Intravenous (IV) use
Initial U.S. Approval: 2009
WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS
See full prescribing information for complete boxed warning.
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
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Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. (5.1)
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Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration. (5.1)
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Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated. (5.1)
RECENT MAJOR CHANGES
Boxed Warning 03/2015
Dosage and Administration (2) 03/2015
Warnings and Precautions,
Serious Hypersensitivity Reactions (5.1) 03/2015
INDICATIONS AND USAGE
Feraheme is an iron replacement product indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). (1)
DOSAGE AND ADMINISTRATION
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The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later.
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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
DOSAGE FORMS AND STRENGTHS
Injection: 510 mg iron per17 mL (30 mg per mL) in single use vials. (3)
CONTRAINDICATIONS
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Known hypersensitivity to Feraheme or any of its components.
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History of allergic reaction to any intravenous iron product
WARNINGS AND PRECAUTIONS
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Greater risk of anaphylaxis in patients with multiple drug allergies. (5.1).
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Hypotension: Feraheme may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of Feraheme. (5.2)
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Iron Overload: Regularly monitor hematologic responses during Feraheme therapy. Do not administer Feraheme to patients with iron overload. (5.3)
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Magnetic Resonance Imaging: Feraheme can alter magnetic resonance imaging (MRI) studies. (5.4)
ADVERSE REACTIONS
The most common adverse reactions (≥ 2%) following the administration of Feraheme are diarrhea, 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.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 3/2015
