Feridex

Generic name: ferumoxides
Dosage form: injection
Drug class:Magnetic resonance imaging contrast media

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

Feridex Description

Feridex I.V.® (ferumoxides injectable solution) is a sterile aqueous colloid of superparamagnetic iron oxide associated with dextran for intravenous (i.v.) administration as a magnetic resonance imaging contrast media. Chemically, ferumoxides is a non-stoichiometric magnetite, of average formula FeO1.44. Each milliliter of Feridex I.V. contains 11.2 milligrams of iron and 61.3 milligrams of mannitol at a pH of 5 to 9. The formulation also contains dextran (5.6– 9.1 mg/mL) and citrate (0.25–0.53 mg/mL). The osmolality is approximately 340 mOsm/kg; specific gravity is 1.04. Feridex I.V. is a black to reddish-brown aqueous colloid.

Feridex - Clinical Pharmacology

General:

Feridex I.V. is an intravenously injected colloidal superparamagnetic iron oxide associated with dextran. It is a magnetic resonance imaging (MRI) contrast agent and is taken up by cells of the reticuloendothelial system (RES).

Pharmacokinetics:

Three healthy, adult male volunteers received a dose of Feridex I.V. 0.56 mg of Fe/kg (diluted in 100 mL of 5% dextrose and intravenously infused over 30 minutes). In these subjects, the mean ± SD peak serum iron concentration was 5.5 ± 0.6 μg/mL, elimination half-life was 2.4 ± 0.2 hours and total clearance 28.5 ± 1.6 mL/min. Feridex I.V. was completely cleared from the blood by 25 hours after administration. Less than 2% of the drug was excreted in the urine, as expected for iron.

At 24 hours, serum iron increased and the percent saturation of iron binding capacity decreased in a dose-dependent fashion. By 7 days, serum iron returned to pre-administration levels, and serum ferritin increased. These results are consistent with the iron in Feridex I.V. entering the usual iron metabolism cycle. Animal pharmacokinetics studies were consistent with these results in humans.

Imaging studies in rats showed a large decrease in liver signal intensity for the first 24 hours after dosing, followed by a gradual return to normal over 7 days. Radiotracer stu...