Ferumoxytol non-stoichiometric magnetite

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 or • who have chronic kidney disease (CKD).

Feraheme consists of a superparamagnetic iron oxide that is coated with a carbohydrate shell, which helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

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 is contraindicated in patients with: • Known hypersensitivity to Feraheme or any of its components • History of allergic reaction to any intravenous iron product • Known hypersensitivity to Feraheme or any of its components. • History of allergic reaction to any intravenous iron product.

Boxed warning (risk for serious hypersensitivity/anaphylaxis reactions): Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest. • Greater risk of anaphylaxis in patients with multiple drug allergies. • 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 Test Interference: Feraheme can alter magnetic resonance imaging (MRI) studies.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Hypersensitivity Reactions • Hypotension • Iron Overload • Magnetic Resonance (MR) Imaging Test Interference The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the absorption of concomitantly administered oral iron preparations.

Storage Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F).