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Feraheme Generic Name & Formulations
Legal Class
Rx
General Description
Elemental iron 30mg/mL (as ferumoxytol 510mg/17mL); colloidal iron for IV infusion after dilution; contains mannitol 44mg/mL; preservative-free.
Pharmacological Class
Hematinic.
How Supplied
Single-dose vials (17mL)—1, 10
Manufacturer
Generic Availability
YES
Feraheme Indications
Indications
Iron deficiency anemia in adults who have intolerance or insufficient response to oral iron; or have chronic kidney disease.
Feraheme Dosage and Administration
Adult
Give by IV infusion over at least 15mins. Initially 510mg, followed by a second 510mg dose 3–8 days later. May repeat treatment if condition persists or reoccurs. Hemodialysis: give at least 1hr after starting hemodialysis and after BP is stable.
Children
<18yrs: not established.
Feraheme Contraindications
Contraindications
History of any IV iron product allergy.
Feraheme Boxed Warnings
Boxed Warning
Risk for serious hypersensitivity/anaphylaxis reactions.
Feraheme Warnings/Precautions
Warnings/Precautions
Risk of serious and fatal hypersensitivity reactions (including anaphylaxis). History of multiple drug allergies. Have equipment/personnel immediately available. Monitor for serious hypersensitivity reactions (including BP and pulse) during and after administration for ≥30mins and until clinically stable. Monitor for signs/symptoms of hypotension after each infusion. Iron overload: do not administer. Evaluate hemoglobin, ferritin, iron, transferrin saturation at least 1 month after 2nd infusion. Elderly. Neonatal. Pregnancy. Nursing mothers.
Feraheme Pharmacokinetics
See Literature
Feraheme Interactions
Interactions
May reduce absorption of concomitant oral iron preparations. May transiently (up to 3mos) affect diagnostic ability of MRI (see full labeling). Concomitant chemotherapy or monoclonal antibodies: separate dosing by at least 30mins. Lab assays may overestimate serum iron and transferrin bound iron within 24hrs after administration.
Feraheme Adverse Reactions
Adverse Reactions
Diarrhea, headache, nausea, dizziness, hypotension (may be severe), constipation, peripheral edema; hypersensitivity/anaphylaxis.
Feraheme Clinical Trials
See Literature
Feraheme Note
Not Applicable
Feraheme Patient Counseling
See Literature
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