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What is Feridex?
What does Feridex look like?
What are the available doses of Feridex?
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What should I talk to my health care provider before I take Feridex?
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How should I use Feridex?
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What interacts with 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.
What are the warnings of Feridex?
If an allergic reaction occurs, the drug should be discontinued and appropriate therapy instituted.
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 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.
What are the precautions of Feridex?
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.
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., 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.
If the physician determines that imaging needs to be repeated, based on the pharmacodynamics of Feridex I.V., 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 section.)
Information for Patients
- If you are pregnant or nursing. (See —— — section.)
- If you are allergic to iron or dextran containing drugs or if you had any reactions to previous injections of dyes used for x-ray procedures. Also, inform your physician or health care provider if you are allergic to any other drugs or food, or if you have immune, autoimmune or immune deficiency disorders. (See — section.)
- About all medications you are currently taking, including non-prescription (over-the-counter) drugs and vitamins, before you have this procedure.
- Feridex I.V. has been prescribed for liver enhancement during MRI.
- Feridex I.V. may cause severe back, groin, leg, or other pain, or allergic reactions.
- The infusion fluid is a dark color.
- The skin surrounding the infusion site may discolor if there is extravasation. The discoloration should disappear over time.
Patients receiving Feridex I.V. should be instructed to inform their physician or health care provider:
Patients should be informed that:
Drug interactions were not noted and were not studied in clinical studies. (See section on .)
Feridex I.V. administration provides elemental iron. In patients who are receiving supplemental iron orally or parenterally, the dose of supplemental iron may need to be decreased.
The effect of concomitant parenteral iron on Feridex I.V. dosing is not known. (See section.)
LABORATORY TEST FINDINGS
Serum iron levels may be above the normal range following Feridex I.V. administration. Transient increases in serum iron of 15-100% of baseline were observed 18 to 24 hours after Feridex I.V. administration, and returned to normal in most patients by 7 days after administration. Increases in serum ferritin levels were seen 1 to 7 days after administration.
(See , section.)
In a Phase 1 study in normal subjects, PTT was statistically significantly increased; however, all values were within the normal range and no subjects had a more than 40% increase from baseline. In clinical trials of patients who had baseline hematologic abnormalities associated with underlying liver disease, an effect of Feridex I.V. on platelet or PTT was not demonstrated.
In patients with low hematocrit and hemoglobin, over a period of 48 hours to 7 days after Feridex I.V., the serum iron, the hematocrit and hemoglobin levels increase slightly.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
Long term studies in animals have not been performed to evaluate the carcinogenic potential of Feridex I.V. 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. has a risk of tumorigenesis that is similar to that of iron dextran is not known.
Feridex I.V. 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. 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.
It is not known whether Feridex I.V. is excreted in human milk. This drug should only be used in nursing women if the benefit clearly outweighs the risk.
Safety and efficacy of Feridex I.V. in the pediatric population have not been established.
What are the side effects of Feridex?
In clinical trials, a total of 2240 subjects (32 healthy volunteers and 2208 patients with known or suspected liver lesions) received Feridex I.V. Of these subjects, 35% received the recommended dose of 0.56 mg Fe/kg and 62% received a dose of 0.84 mg Fe/kg. Forty-four percent were female and 56% were male, with a mean age of 54.9 years (range 11–89).
Of 866 subjects in whom race is known, 647 (75%) were Asian, 199 (22%) were Caucasian, 14 (2%) were Black, 3 (
Of the 2240 subjects, 197 (8.8%) experienced an adverse event. The most commonly noted adverse experiences were back pain (3.4%), and vasodilation (2.3%).
In a subgroup of 1535 patients in controlled clinical trials, in 44 (2.9%) of the patients [9/226 (3.9%) in US, 10/635 (1.6%) in Japanese, and 25/674 (3.7%) in European studies] the infusion was interrupted or discontinued because of acute, moderate to severe pain (back, lower torso, chest, groin, or upper leg) with or without hypotension. Some patients required treatment. In a few of the patients with pain 11/44 (25%), the infusion was interrupted, restarted, and completed. (See section.)
Pain in any location was reported in 4.2% of these 1535 patients given Feridex I.V.
In a subgroup of 689 patients in whom associated underlying disorders were evaluated, back pain occurred in 18/144 (12.5%) patients with cirrhosis and in 10/545 (1.8%) patients who did not have cirrhosis. The frequency of pain in patients with other liver abnormalities is not known.
Anaphylactic and allergic adverse events (e.g., generalized urticaria, respiratory symptoms, and hypotension) that required acute treatment occurred in 11/2240 (0.5%) of patients who received Feridex I.V.
Most other adverse reactions were mild to moderate, of short duration, and resolved spontaneously without treatment. A relationship between adverse events and dose, age, or gender was not observed.
Adverse reactions that occurred in greater than or equal to 0.5% of the 1535 patients in controlled clinical trials are listed below in related categories, in decreasing order of occurrence within each system, and regardless of causality:
The following adverse reactions were observed in
(See sections on , and .)
In 705 patients who received Feridex I.V. in other trials, similar adverse events were reported.
|Digestive System||Nausea||11 (0.7%)|
|Body as a whole|
What should I look out for while using Feridex?
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What might happen if I take too much Feridex?
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How should I store and handle Feridex?
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While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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