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 Serious hypersensitivity reactions have been reported following AdreView administration.
The most common adverse reactions, dizziness, rash, pruritis, flushing, headache, and injection site hemorrhage occurred in < 1.3% of patients.
( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Study 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 practice.
During clinical development 1346 patients were exposed to AdreView, 251 patients with known or suspected pheochromocytoma or neuroblastoma, 985 patients with heart failure, and 110 control patients.
All patients were monitored for adverse reactions over a 24 hour period following AdreView administration.
Pheochromocytoma and Neuroblastoma Serious adverse reactions were not observed in the AdreView clinical study.
Adverse reactions were all mild to moderate in severity and were predominantly isolated occurrences (≤ 2 patients) of one of the following reactions: dizziness, rash, pruritus, flushing or injection site hemorrhage.
Congestive Heart Failure No serious adverse reactions to AdreView were observed in clinical studies.
Adverse reactions that occurred with a frequency > 1% were associated with the injection site (1.3%), problems such as hematoma and bruising.
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions have followed AdreView administration.
Have anaphylactic and hypersensitivity treatment measures available prior to AdreView administration.
( 5.1 ) Drugs which block norepinephrine uptake or deplete norepinephrine stores may decrease AdreView uptake.
When medically feasible, stop these drugs before AdreView administration and monitor patients for withdrawal signs and symptoms.
( 5.2 ) AdreView contains benzyl alcohol (10.3 mg/mL) which may cause serious reactions in premature or low birth-weight infants.
Like all medications, Adreview 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: