| HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Feraheme safely and effectively. See full prescribing information for Feraheme.
Feraheme® (ferumoxytol) Injection
Feraheme injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.
| CLINICAL PHARMACOLOGY
Mechanism of Action
| 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).
Known hypersensitivity to Feraheme or any of its components.
History of allergic reaction to any intravenous iron product.
| WARNINGS AND PRECAUTIONS
--Hypersensitivity Reactions: Observe for signs and symptoms of hypersensitivity during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each administration.
--Hypotension: Feraheme may cause hypotension. Monitor for signs and symptoms of hypotension following each administration of Feraheme.
--Iron Overload: Regularly monitor hematologic responses during Feraheme therapy. Do not administer Feraheme to patients with iron overload.
-- Magnetic Resonance Imaging: Feraheme can alter magnetic resonance imaging (MRI) studies.
| ADVERSE REACTIONS
The most common adverse reactions (>/= 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.
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
| 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. Administer while the patient is in a reclined or semi-reclined position.
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.
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) at least one month following the second Feraheme infusion. The recommended Feraheme dose may be readministered to patients with persistent or recurrent iron deficiency anemia.
For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme infusion.
Allow at least 30 minutes between administration of Feraheme and administration of other medications that could potentially cause serious hypersensitivity reactions and/or hypotension, such as chemotherapeutic agents or monoclonal antibodies.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.
| DOSAGE FORMS AND STRENGTHS
Feraheme Injection is available in single use vials. Each vial contains 510 mg of elemental iron in 17 mL (30 mg per mL).
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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