Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in labeling: Nephrogenic Systemic Fibrosis [see Warnings and Precautions ( 5.2 )] Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.3 )] Most common adverse reactions (incidence >0.2%) are injection site pain, headache, nausea, injection site warmth and coldness, dizziness, localized swelling, and erythema.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS contact Bracco Diagnostics Inc.
at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 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 safety of Vueway was evaluated in 1,083 patients who received Vueway at doses ranging from 0.025 mmol/kg (one half the recommended dose) to 0.3 mmol/kg (six times the recommended dose).
A total of 744 patients (including 116 pediatric patients) received the recommended dose of 0.05 mmol/kg.
Among patients who received the recommended dose, the average age was 49 years (range from less than one month to 88 years) and 55% were female.
The race distribution was 80% White, 10% Asian, 6% American Indian or Alaska native, 2% Black, and 2% patients of other or unspecified race groups.
Overall, approximately 4.6% of subjects receiving the labeled dose reported one or more adverse reactions.
Table 1 lists adverse reactions that occurred in > 0.2% of patients who received 0.05 mmol/kg Vueway.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious hypersensitivity reactions have occurred with GBCAs.
Monitor patients closely for need of emergency cardiorespiratory support.
( 5.3 ) Gadolinium Retention: Gadolinium is retained for months or years in brain, bone, and other organs.
( 5.4 ) 5.1 Risk Associated with Intrathecal Use Intrathecal administration of GBCAs can cause serious adverse reactions including death, coma, encephalopathy, and seizures.
The safety and effectiveness of Vueway have not been established with intrathecal use.
Like all medications, Vueway can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: