Approved June 30, 2009

FERUMOXYTOL
(FDA Category 2S)

Feraheme(TM) (AMAG Pharmaceuticals, Inc) is a superparamagnetic iron oxide which releases iron in the macrophages to be stored as ferritin or for incorporation into hemoglobin.

DOSING INFORMATION: The recommended dose is 510 mg IV followed by a second dose given 3 to 8 days later. The ferumoxytol dosage regimen may be repeated in patients with persistent or recurrent iron deficiency anemia.

PHARMACOKINETICS: Following 2 doses of ferumoxytol 510 mg given 24 hr apart in healthy subjects and in patients on hemodialysis, the estimated ferumoxytol clearance and volume of distribution were 69.1 mL/hr and 3.16 L, respectively. Additionally, the ferumoxytol peak concentration was 206 mcg/mL, time to peak concentration was 0.32 hr, and elimination half-life was 15 hr.

CAUTIONS: Ferumoxytol is contraindicated in patients with evidence of iron overload, known hypersensitivity to ferumoxytol or any of its components, and anemia not caused by iron deficiency. Monitoring for iron overload is recommended. The most common side effects are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.

FDA APPROVED INDICATION: Ferumoxytol is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.