Ferumoxytol (3 brand names, 1 dosage form, 1 route)
Available dosage forms: SOLUTION.
Routes of administration: INTRAVENOUS.
Brand Names
- FERABRIGHT
- FERAHEME
- FERUMOXYTOL
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. • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see Warnings and Precautions (5.1)] . • 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 [see Warnings and Precautions (5.1)]. • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated [see Warnings and Precautions (5.1)].
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).
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) 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.
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)]
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)]
Drug Interactions
Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the absorption of concomitantly administered oral iron preparations.
Mechanism of Action
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.
Overdosage
Limited data are available regarding overdosage of Feraheme in humans. Excessive dosages of Feraheme may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Feraheme to patients with iron overload [Warnings and Precautions (5.3)]. Feraheme is not removed by hemodialysis. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.