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FERAHEME
Anemias
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Drug Name:

FERAHEME Rx

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.

Company:
AMAG Pharmaceuticals

Therapeutic Use:

Indications for FERAHEME:

Iron deficiency anemia in adults who have intolerance or insufficient response to oral iron; or have chronic kidney disease.

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.

Contraindications:

History of any IV iron product allergy.

Boxed Warning:

Risk of serious hypersensitivity/anaphylaxis reactions.

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. Pregnancy. Nursing mothers.

Pharmacological Class:

Hematinic.

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.

Adverse Reactions:

Diarrhea, headache, nausea, dizziness, hypotension (may be severe), constipation, peripheral edema; hypersensitivity/anaphylaxis.

How Supplied:

Single-use vials (17mL)—1, 10

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