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 Anaphylactic or urticarial reactions have been reported in patients with or without history of allergy to iodides.
If such reactions occur, treat with the appropriate agents, e.g., epinephrine, antihistamines, and corticosteroids.
Most common adverse reactions are anaphylactic or urticarial reactions.
These have been reported in patients with and without a history of allergy to iodides.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Diagnostic Green LLC at 1-844-424-3784 (1-844-ICG-DRUG) or e-mail: drugsafety@ diagnosticgreen.com;
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS • Deaths due to anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.
( 5.1 ) • Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours.
( 5.2 ) • Radioactive iodine uptake studies should not be performed for at least a week following the use of Indocyanine Green for Injection USP.
( 5.3 ) 5.1 Anaphylaxis Deaths from anaphylaxis have been reported following Indocyanine Green for Injection USP administration during cardiac catheterization.
5.2 Drug Instability Indocyanine Green for Injection USP is unstable in aqueous solution and must be used within 6 hours.
Like all medications, Indocyanine Green 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: