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The following serious but uncommon adverse reactions that have been associated with gadolinium-based contrast agents may be associated with the use of EOVIST are discussed elsewhere in the labeling:
- Nephrogenic systemic fibrosis [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The data described below reflect EOVIST exposure in 1989 subjects who received a dose that ranged from 0.003 to 0.5 mmol/kg body weight; the majority (n=1581) received the recommended dose of 0.025 mmol/kg body weight. Overall, 59% of the subjects were men and the ethnic distribution was 64 % Caucasian, 22% Asian, 3 % Hispanic, 2% Black, and 0.5% subjects of other ethnic groups. The average age was 57.4 years (range from 19 to 84 years).
Overall, 4.3% of subjects reported one or more adverse reactions during a follow-up period that for most subjects, extended 24 hours after EOVIST administration.
The adverse reactions were predominantly of mild to moderate severity.
Table 1 lists adverse reactions that occurred in ≥ 0.1% subjects treated with EOVIST at the recommended dose of 0.025 mmol/kg body weight.
TABLE 1: Adverse Reactions
n = 1581
|Blood pressure increased||0.4|
|Injection site reactions (Pain, Burning, Coldness, Extravasation, Irritation)||0.4|
|Pruritus (generalized, eye)||0.3|
|Respiratory disorders (Dyspnea, Respiratory distress)||0.2|
Adverse reactions that occurred with a frequency of < 0.1% in subjects treated with EOVIST at the recommended dose of 0.025 mmol/kg body weight include: tremor, akathisia, bundle branch block, palpitation, oral discomfort, salivary hypersecretion, maculopapular rash, hyperhidrosis, discomfort, and malaise.
Elevation of serum iron values and serum bilirubin laboratory values were reported in less than 1% of patients after administration of EOVIST. The values did not exceed more than 2–3 times the baseline values and returned to baseline within 1 to 4 days without other signs or symptoms of other abnormalities.
The following additional adverse reactions have been reported during the post-marketing use of EOVIST. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The reports were for
- Hypersensitivity/anaphylactoid reactions including shock, hypotension, pharyngolaryngeal edema, urticaria, face edema, rhinitis, conjunctivitis, abdominal pain, hypoesthesia, sneezing, cough and pallor [see WARNINGS AND PRECAUTIONS].
Read the Eovist (gadoxetate disodium injection) Side Effects Center for a complete guide to possible side effects
Interference with OATP Inhibitors
An interaction study in healthy subjects demonstrated that the co-administration of the OATP inhibitor erythromycin did not influence efficacy and pharmacokinetics of EOVIST. No further clinical interaction studies with other medicinal products have been performed.
Interference with Laboratory Tests
Serum iron determination
Serum iron determination using complexometric methods (for example, Ferrocine complexation method) may result in falsely high or low values for up to 24 hours after the examination with EOVIST because of the caloxetate trisodium excipients.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/7/2011
Additional Eovist Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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