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 adult patients with chronic kidney disease.
Give by IV infusion over at least 15 mins. Initially 510mg, followed by a second 510mg dose 3–8 days later. May repeat in persistent or recurrent iron deficiency anemia. Hemodialysis: give at least 1 hour after starting hemodialysis and after BP is stable.
<18yrs: not established.
History of any IV iron product allergy.
Iron overload: do not administer. Monitor for severe hypotension, and for hypersensitivity for at least 30 minutes after each infusion. Evaluate hemoglobin, ferritin, iron, transferrin saturation at least 1 month after 2nd infusion. Have equipment/personnel available to treat hypersensitivity reactions. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
May reduce absorption of concomitantly administered oral iron preparations. May transiently (up to 3 months) affect diagnostic ability of MRI (see full labeling). Concomitant chemotherapy or monoclonal antibodies: separate dosing by at least 30 mins.
Diarrhea, nausea, hypotension (may be significant), dizziness, constipation, peripheral edema; infusion reactions, anaphylactic reactions (may be fatal), other hypersensitivity reactions (eg, rash, pruritus, urticaria, wheeze).
Single-use vials (17mL)—1, 10