SIDE EFFECTS

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. (ferumoxides injectable solution)

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. (ferumoxides injectable solution)

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:

ADVERSE EVENTS IN ≥ 0.5% OF THE 1535 PATIENTS IN CONTROLLED CLINICAL TRIALS WITH FERIDEX I.V. (ferumoxides injectable solution)

The following adverse reactions were observed in < 0.5% of the subjects receiving Feridex I.V. (ferumoxides injectable solution) : DIGESTIVE: diarrhea, vomiting, anorexia; BODY PAIN: pain abdomen, pain neck, fatigue, fever; CARDIOVASCULAR: hypertension, hypotension, arrhythmias; NERVOUS: dizziness, paresthesia; SKIN AND APPENDAGES: pruritus, sweating; SPECIAL SENSES: abnormal vision, taste perversion; RESPIRATORY: cough, epistaxis, rhinitis. (See sections on CONTRAINDICATIONS, WARNINGS and PRECAUTIONS.)

In 705 patients who received Feridex I.V. (ferumoxides injectable solution) in other trials, similar adverse events were reported.

Read the entire FDA prescribing information for Feridex IV (Ferumoxides Injectable Solution) »