Ferumoxides (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- FERIDEX I.V.
Indications and Usage
Feridex I.V. is indicated for I.V. administration as an adjunct to MRI (in adult patients) to enhance the T2 weighted images used in the detection and evaluation of lesions of the liver that are associated with an alteration in the RES.
Contraindications
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.
Adverse Reactions
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 (<1%) were Hispanic, and 3 (<1%) other. Racial demographic information was not available for the 1374 subjects in European clinical trials.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 WARNINGS 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
Drug Interactions
Drug interactions were not noted and were not studied in clinical studies. (See CLINICAL PHARMACOLOGY section on Drug-Drug Interactions.)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 CLINICAL PHARMACOLOGY section.)
Overdosage
Overdose with Feridex I.V. has not been reported. Acute toxicity is apt to be related to iron overload, acute back pain and allergic events. Chronic administration of therapeutic iron dextran in excess of the total amount of iron needed for iron stores may lead to hemosiderosis.A study of (59Fe) complexed iron-dextran utilizing isotonic saline in a 4-hour in vitro dialysis run indicated that less than 0.5% of the injected radio labeled iron dextran traversed the dialysis membrane. Feridex I.V. contains iron associated with dextran. Whether Feridex I.V. is dialyzable is not known.