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)
|Categories||Adverse Event||Number of Patients (%)|
|Number of patients who received Feridex I.V.||1535|
|Number of patients with any adverse event||144 (9.4%)|
|Digestive System||Nausea||11 (0.7%)|
|Body as a whole||Total (pain all sources)||65 (4.2%)|
|Pain Back/Leg/Pain Leg||56 (3.6%)|
|Pain Chest||10 (0.7%)|
|Hypersensitivity||Total (hypersensitivity all sources)||53 (3.4%)|
|Urticaria/Erythematous Rash/Rash||12 (0.7%)|
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 Feridex I.V. (ferumoxides injectable solution) Side Effects Center for a complete guide to possible side effects
Drug interactions were not noted and were not studied in clinical studies. (See CLINICAL PHARMACOLOGY section on Drug-Drug Interactions.)
Feridex I.V. (ferumoxides injectable solution) 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.)
Laboratory Test Findings
Serum iron levels may be above the normal range following Feridex I.V. (ferumoxides injectable solution) administration. Transient increases in serum iron of 15–100% of baseline were observed 18 to 24 hours after Feridex I.V. (ferumoxides injectable solution) 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 CLINICAL PHARMACOLOGY, Pharmacokinetics 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. (ferumoxides injectable solution) 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. (ferumoxides injectable solution) , the serum iron, the hematocrit and hemoglobin levels increase slightly.
Last reviewed on RxList: 12/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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