Generic Name and Formulations:
Elemental iron 30mg/mL (as ferumoxytol 510mg/17mL); colloidal iron for IV infusion after dilution; contains mannitol 44mg/mL; preservative-free.
Indications for FERAHEME:
Iron deficiency anemia in adults who have intolerance or insufficient response to oral iron; or have chronic kidney disease.
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.
<18yrs: not established.
History of any IV iron product allergy.
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. Pregnancy. Nursing mothers.
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.
Diarrhea, headache, nausea, dizziness, hypotension (may be severe), constipation, peripheral edema; hypersensitivity/anaphylaxis.
Single-use vials (17mL)—1, 10