Feridex

Feridex I.V. is contraindicated in patients with known allergic or hypersensitivity reactions to parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations.

Anaphylactic-like reactions and hypotension have been noted in some patients receiving Feridex I.V., other iron and dextran containing formulations, or radiographic contrast media. In clinical trials, anaphylactic and allergic adverse events occurred in 11/2240 (0.5%) of the patients who received Feridex I.V. These events include dyspnea, other respiratory symptoms, angioedema, generalized urticaria, and hypotension; and required treatment.

Acute severe back, leg or groin pain occurred in some patients. In clinical trials, 55/2240 (2.5%) of the patients experienced pain that was severe enough to cause interruption or discontinuation of the infusion. In most patients, the symptoms developed within 1 to 15 minutes (up to 45 minutes). Some patients required treatment with corticosteroids, intravenous fluids or muscle relaxants. Pain may occur alone or with other symptoms such as hypotension and dyspnea. Patients with both pain and allergic symptoms received treatment with a combination of medications directed toward each event. (See ADVERSE REACTIONS section.)

Patients with autoimmune disease have not been studied with Feridex I.V., but have been reported in published literature to have a high rate of adverse reactions to injectable iron formulations.

If hypersensitivity, or moderate to severe pain occurs, the injection should be stopped, and symptomatic treatment should be given.

A fully equipped emergency cart, or equivalent supplies and equipment, and personnel competent in recognizing and treating anaphylactic or anaphylactoid reactions should be available.

Storage at 2–30 °C (35–86 °F). DO NOT FREEZE.

If there are indications that the package has been exposed to freezing, DO NOT USE.

Rx Only

The following patents have claims directed to the drug: U.S.P. 4,770,183, U.S.P. 4,827,945, U.S.P. 4,951,675, U.S.P. 5,055,288, U.S.P. 5,102,652, U.S.P. 5,219,554, U.S.P. 5,248,492

Manufactured for:

Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470

Manufactured by Advanced Magnetics, Inc., Cambridge, MA 02138

Feridex I.V.  is a registered trademark of Advanced Magnetics, Inc.

© 2007, Bayer HealthCare Pharmaceuticals Inc. All rights reserved

Revised May 2007 Printed in USA 6700900/6102 REV 08

Substance Name

Ferumoxides

CAS Registry Number

119683-68-0

Drug Class

Contrast Agents

Diagnostic Agents

LactMed Record Number

534

Last Revision Date

20130907

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