Indocyanine Green · powder for injection
Diagnostic Dye, Injections & Implants
Approved uses
Ophthalmic angiography of the choroidal vasculature
Up to 40 mg in 2 mL of Sterile Water for Injection as an antecubital vein bolus, followed immediately by a 5 mL bolus of normal saline
OFF-LABELNot in the FDA label for this product
Internal limiting membrane staining during macular hole surgery
0.05% (0.5 mg/mL) applied intraocularly over the macula to stain the membrane before peeling, an intraocular rather than intravenous route
Meta-analysis · 12/17 retro
A network meta-analysis of 17 studies (12 retrospective, 5 randomized) in 1492 patients with stage II to IV idiopathic macular hole found that peeling with 0.25% of this dye performed worse for hole closure than peeling with no dye at all, while 0.05% brilliant blue G, 0.15% trypan blue, 0.5% and 0.05% of this dye all outperformed 0.25%; the authors suggest 0.05% as a good choice for surgeons who prefer this dye, and call for large high-quality randomized trials to confirm the ranking. A separate meta-analysis of 9 studies and 846 eyes found better postoperative acuity with brilliant blue G than with this dye (mean difference -0.10 logMAR, 95% CI -0.16 to -0.03, P=0.004, negative favoring brilliant blue G) but no significant difference in closure rate (OR 1.98, 95% CI 0.71 to 5.48, P=0.19).
Contraindications
History of allergy to iodides; the product contains sodium iodide and the label directs caution rather than avoidance.
25 mg lyophilized powder in a 30 mL vial, supplied as a kit of six 25 mg vials with six 10 mL Sterile Water for Injection vials
Water-soluble tricarbocyanine dye with peak spectral absorption near 800 nm, a region where the pigment epithelium transmits energy more efficiently than visible light, so the choroidal circulation can be imaged through it. Nearly 98% bound to blood protein, so it does not extravasate appreciably from the highly fenestrated choroidal vasculature, and it is taken up almost exclusively by hepatic parenchymal cells and secreted entirely into bile.
Warnings & Precautions
- Anaphylactic deaths: Reported following administration during cardiac catheterization; the label's stated treatment for an anaphylactic or urticarial reaction is epinephrine, antihistamines, and corticosteroids.
- Solution instability: Unstable in aqueous solution, so use within 6 hours of reconstitution and discard if a precipitate is present; the dye is stable in plasma and whole blood, so drawn samples can be read hours later.
- Radioactive iodine uptake studies: Do not perform for at least 1 week after administration.
- Heparin containing sodium bisulfite: Reduces the absorption peak in blood, so it should not be used as the anticoagulant when collecting samples for analysis.
Common Side Effects
- Hypersensitivity: Anaphylactic or urticarial reactions have been reported in patients with or without a history of allergy to iodides.
- Reaction frequency: Across 1923 ophthalmic videoangiograms in 1226 consecutive patients there were 3 mild (0.15%), 4 moderate (0.2%), and 1 severe (0.05%) reaction and no deaths; a 15-institution Japanese survey of 3774 angiograms recorded 13 reactions (0.34%), 10 of them mild, with 2 patients treated for shock and 1 injection-site vein pain requiring treatment.
Pregnancy: Category C, with no animal reproduction studies conducted and no data on whether it causes fetal harm or affects reproductive capacity; give only if clearly indicated.
Lactation: Excretion in human milk is unknown, and the label advises caution in a nursing woman.
Safety and effectiveness in pediatric patients have been established.