Feridex I.V.

Warnings
Precautions

WARNINGS

Anaphylactic-like reactions and hypotension have been noted in some patients receiving Feridex I.V. (ferumoxides injectable solution) , 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. (ferumoxides injectable solution) 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. (ferumoxides injectable solution) , 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.

PRECAUTIONS

General

THE DECISION TO USE CONTRAST ENHANCEMENT SHOULD INCLUDE A CONSIDERATION OF THE RISK OF THE DRUG, THE RISK OF THE PROCEDURE, THE EXPECTED BENEFIT OF THE IMAGE AND THE PATIENT'S UNDERLYING DISORDER. THE DECISION TO USE FERIDEX I.V. SHOULD BE BASED UPON CAREFUL EVALUATION OF CLINICAL DATA, OTHER RADIOLOGIC DATA, AND THE RESULTS OF UNENHANCED MRI.

Patients receiving contrast agents and especially those who are medically unstable must be closely supervised. Diagnostic procedures which involve the use of any contrast agent should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed.

After parenteral administration of a contrast agent, competent personnel, a fully equipped emergency cart or equivalent, and emergency facilities should be available for at least 60 to 120 minutes.

Immunologic Reactions

The possibility of a reaction including serious, life-threatening, fatal, anaphylactoid or cardiovascular reactions should always be considered. Increased risk is associated with a known sensitivity to iron or dextran, history of previous reaction to a radiographic contrast agent, known allergies, other hypersensitivities, and underlying immune disorders, autoimmunity or immunodeficiencies that predispose to specific or non specific mediator release.

Skin testing cannot be relied upon to predict severe reactions and skin testing may itself be hazardous to the patient. A thorough medical history with emphasis on allergy and hypersensitivity, immune, autoimmune and immunodeficiency disorders, and prior receipt of and response to the injection of any contrast agent, may be more accurate than pretesting in predicting potential adverse reactions.

Feridex I.V. (ferumoxides injectable solution) , which contains iron, should be used with caution in patients with disorders associated with iron over load (e.g., hemosiderosis, chronic hemolytic anemia with frequent blood transfusions).

Extreme caution during injection of a contrast agent is necessary to avoid extravasation. This is especially important in patients with severe arterial or venous disease.

Repeat Procedures: If the physician determines that imaging needs to be repeated, based on the pharmacodynamics of Feridex I.V. (ferumoxides injectable solution) , repeat images could be obtained up to 3.5 hours after the original infusion without re-injection. Data on timing for and safety of repeated injections are not available. (See CLINICAL PHARMACOLOGY section.)

Carcinogenesis, Mutagenesis, And Impairment Of Fertility

Long term studies in animals have not been performed to evaluate the carcinogenic potential of Feridex I.V. (ferumoxides injectable solution) Therapeutic iron dextran products have been associated with the development of sarcomas at the intramuscular injection sites; the length of treatment or the length of time after injection until development of tumor is not known. Ferumoxides are iron oxides associated with dextran. Whether Feridex I.V. (ferumoxides injectable solution) has a risk of tumorigenesis that is similar to that of iron dextran is not known.

Feridex I.V. (ferumoxides injectable solution) was not genotoxic in a series of studies that included the Ames test, the CHO/HGPRT forward mutation assay, a chromosome aberration test in CHO cells, an unscheduled DNA synthesis assay, and a micronucleus assay in mice.

Feridex I.V. (ferumoxides injectable solution) did not impair the fertility of male or female rats at dosages that were up to approximately 5 times the clinical dose when normalized to body surface area.

Pregnancy

Teratogenic Effects
Pregnancy Category C

Feridex I.V. (ferumoxides injectable solution) is teratogenic in rabbits at all studied doses. The smallest dose studied was approximately six times the clinical dose when normalized to body surface area. Adequate and well controlled studies were not conducted in pregnant women. Feridex I.V. (ferumoxides injectable solution) should be used during pregnancy only if the potential benefit justifies the potential risk.

Nursing Mothers

It is not known whether Feridex I.V. (ferumoxides injectable solution) is excreted in human milk. This drug should only be used in nursing women if the benefit clearly outweighs the risk.

Pediatric Use

Safety and efficacy of Feridex I.V. (ferumoxides injectable solution) in the pediatric population have not been established.

Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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