QUEST SPECTRUM
®
3
p. 11/50
Instructions for Use
4 ICG Safety
4.1 Clinical Pharmacology
Following intravenous injection, Indocyanine Green (ICG) is rapidly bound to plasma protein, of which
albumin is the principle carrier (95%). ICG undergoes no significant extrahepatic or enterohepatic
circulation; simultaneous arterial and venous blood estimations have shown negligible renal, peripheral,
lung or cerebral-spinal uptake of the dye. ICG is taken up from the plasma almost exclusively by the
hepatic parenchymal cells and is secreted entirely into the bile. After biliary obstruction, the dye appears
in the hepatic lymph, independently of the bile, suggesting that the biliary mucosa is sufficiently intact to
prevent diffusion of the dye, though allowing diffusion of bilirubin. These characteristics make ICG a
helpful index of hepatic function.
The plasma fractional disappearance rate at the recommended 0.5 mg/kg dose has been reported to be
significantly greater in women than in men, although there was no significant difference in the calculated
value for clearance.
4.2 Contraindications
ICG for Injection USP contains sodium iodide and should be used with caution in patients who have a
history of allergy to iodides.
4.2.1 General
ICG Powder and Solution: ICG is unstable in aqueous solution and must be used within 6 hours.
However, the dye is stable in plasma and whole blood so that samples obtained in discontinuous sampling
techniques may be read hours later. Sterile techniques should be used in handling the dye solution as
well as in the performance of the dilution curves.
ICG powder may cling to the vial or lump together because it is freeze-dried in the vials. This is not due
to the presence of water - the moisture content is carefully controlled. The ICG is suitable for use.
4.2.2 Drug Interactions
Heparin preparations containing sodium bisulfite reduce the absorption peak of ICG in blood and,
therefore, should not be used as an anticoagulant for the collection of samples for analysis.
4.2.3 Drug/Laboratory Test Interactions
Radioactive iodine uptake studies should not be performed for at least a week following the use of ICG.
4.2.4 Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been performed to evaluate the carcinogenicity, mutagenicity, or impairment of fertility.
Pregnancy Category C: Animal Reproduction studies have not been conducted with ICG. It is not known
whether ICG can cause fatal harm when administered to a pregnant woman or can affect reproduction
capacity. ICG should be given to a pregnant woman only if clearly indicated.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when ICG is administered to a nursing
woman.
4.2.5 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4.2.6 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger
patients.
