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 Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting.
Have emergency resuscitation equipment and personnel immediately available.
Hypersensitivity reactions have occurred;
have emergency resuscitation equipment and personnel immediately available ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS • Radiation risks: use smallest dose necessary for imaging ( 5.1 ).
• Blood glucose abnormalities: may cause suboptimal imaging ( 5.2 ).
5.1 Radiation Risks Radiation-emitting products, including Fludeoxyglucose F-18 Injection, may increase the risk for cancer, especially in pediatric patients.
Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker [ see Dosage and Administration ( 2.5 ) ].
5.2 Blood Glucose Abnormalities In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels.
Like all medications, Fludeoxyglucose F-18 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: