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Indocyanine green: Drug information

Indocyanine green: Drug information
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For additional information see "Indocyanine green: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • IC Green;
  • Spy Agent Green;
  • Spy- MIS Kit;
  • SPY-PHI Kit
Brand Names: Canada
  • Spy Agent Green;
  • Spy Agent Green AIM/Pinpoint;
  • Spy Agent Green Lymphat Pinpoi;
  • Spy Agent Green Spy Elite;
  • Spy Agent Green Spy Phi
Pharmacologic Category
  • Diagnostic Agent
Dosing: Adult

US labeling:

Blood flow, tissue perfusion, and vessel visualization

Blood flow, tissue perfusion, and vessel visualization (Spy Agent Green) : IV: 1.25 to 5 mg for a single image sequence or 3.75 to 10 mg for visualization of extremities through the skin; additional doses may be administered at the discretion of the imaging health care provider. Maximum total dose: 2 mg/kg. Immediately follow with a 10 mL bolus of NS.

Cardiac output determination

Cardiac output determination (IC Green): IV: 5 mg injected rapidly via a cardiac catheter; maximum total dose: 2 mg/kg.

Note: An average of 5 dilution curves are needed in a diagnostic cardiac catheterization; doses are usually injected in 1 mL volume. Flush dye from catheter with NS to prevent hemolysis.

Extrahepatic biliary ducts imaging

Extrahepatic biliary ducts imaging (Spy Agent Green): IV: 2.5 mg as a single dose at least 45 minutes prior to surgery; additional doses may be administered to obtain imaging sequences. Maximum total dose: 2 mg/kg.

Hepatic function studies

Hepatic function studies (IC Green): IV: 0.5 mg/kg; patient should be in a fasting basal state.

Lymphatic mapping of breast cancer

Lymphatic mapping of breast cancer (Spy Agent Green): Intradermal: 0.25 mg per breast (divided as 2 injections of 0.05 mL of a 2.5 mg/mL solution); an additional 0.375 mg (divided as 3 injections of 0.05 mL) is recommended if lymphatic flow towards the axillary lymph nodes is not visualized.

Lymphatic mapping of cervical and uterine cancer

Lymphatic mapping of cervical and uterine cancer (Spy Agent Green): Interstitial: 5 mg (divided as 4 injections of 1 mL of a 1.25 mg/mL solution) into cervix.

Ophthalmic angiography

Ophthalmic angiography (IC Green): IV: Up to 40 mg (depending on the imaging equipment and technique used); immediately follow with a 5 mL bolus of NS.

Canadian labeling:

Blood flow and tissue perfusion imaging

Blood flow and tissue perfusion imaging: IV: 1.25 mg to 5 mg for a single image sequence or 3.75 mg to 10 mg for visualization of extremities through the skin; an additional 2 to 3 doses may be administered at the discretion of the imaging health care provider. Maximum total dose: <2 mg/kg. Immediately follow with a 10 mL bolus of NS.

Extrahepatic biliary anatomy imaging

Extrahepatic biliary anatomy imaging: IV: 2.5 mg; an additional 2 to 3 doses may be administered at the discretion of the imaging health care provider. Maximum total dose: <2 mg/kg.

Lymph node and lymphatic vessels imaging

Lymph node and lymphatic vessels imaging: Interstitial: 5 mg (divided as 4 injections of 1.25 mg/mL) into cervix.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Indocyanine green: Pediatric drug information")

Dosage guidance:

Safety: Dosing varies depending upon the product and indication; use caution. Administer in a health care setting that includes cardiopulmonary monitoring and can provide resuscitation if necessary.

Blood flow, tissue perfusion, and vessel visualization

Blood flow, tissue perfusion, and vessel visualization: Infants ≥1 month, Children, and Adolescents: IC-Green, Spy Agent Green: IV: 1.25 to 5 mg; lower doses may be used for younger patients and/or patients with lower body weight. Additional doses may be administered as needed to obtain imaging sequences during the procedure; not to exceed a maximum total dose: 2 mg/kg.

Extrahepatic biliary ducts imaging

Extrahepatic biliary ducts imaging: Children ≥12 years and Adolescents: IC-Green, Spy Agent Green: IV: 2.5 mg at least 45 minutes prior to surgery; additional doses may be administered as needed to obtain imaging during the procedure; not to exceed a maximum total dose: 2 mg/kg.

Ophthalmic angiography

Ophthalmic angiography: Infants, Children, and Adolescents: IC-Green: IV: Dose is variable based on patient age/weight, imaging equipment, and technique used; administer once, not to exceed a maximum of 40 mg/dose (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

1% to 10%: Dermatologic: Skin discoloration (1%; including skin discoloration at injection site)

Postmarketing:

Cardiovascular: Hemodynamic deterioration (decreased blood pressure, increased heart rate) (Zhai 2017)

Dermatologic: Urticaria (Higuchi 2019)

Hypersensitivity: Anaphylactic shock (Higuchi 2019), anaphylaxis (Higuchi 2019), type I hypersensitivity reaction (Meira 2020)

Contraindications

History of hypersensitivity (anaphylaxis) to indocyanine green or any component of the formulation (Spy Agent Green); hypersensitivity to iodides (IC Green).

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Anaphylaxis and urticaria has been reported, including anaphylactic deaths during IV administration, have been reported; cardiopulmonary resuscitation personnel and equipment should be readily available.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Injection:

Spy Agent Green: Methyl salicylate 10% and menthol 3% (1 ea)

SPY-PHI Kit: Methyl salicylate 10% and menthol 3% (1 ea)

Solution Reconstituted, Injection [preservative free]:

IC Green: Methyl salicylate 10% and menthol 3% (1 ea)

Spy- MIS Kit: Methyl salicylate 10% and menthol 3% (1 ea)

Solution Reconstituted, Intravenous:

IC Green: 25 mg (1 ea [DSC])

Generic: 25 mg (1 ea)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (reconstituted) (IC Green Injection)

25 mg (per each): $357.29

Solution (reconstituted) (Indocyanine Green Intravenous)

25 mg (per each): $254.69

Solution (reconstituted) (Spy Agent Green Injection)

25 mg (per each): $5,459.05

Solution (reconstituted) (Spy- MIS Kit Injection)

25 mg (per each): $1,669.50

Solution (reconstituted) (SPY-PHI Kit Injection)

25 mg (per each): $883.34

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Spy Agent Green: Methyl salicylate 10% and menthol 3% (1 ea)

Spy Agent Green AIM/Pinpoint: Methyl salicylate 10% and menthol 3% (1 ea)

Spy Agent Green Lymphat Pinpoi: Methyl salicylate 10% and menthol 3% (1 ea)

Spy Agent Green Spy Elite: Methyl salicylate 10% and menthol 3% (1 ea)

Spy Agent Green Spy Phi: Methyl salicylate 10% and menthol 3% (1 ea)

Solution Reconstituted, Intravenous:

Generic: 25 mg (1 ea)

Administration: Adult

US labeling:

IV:

Blood flow, tissue perfusion, and vessel visualization: Administer as a bolus injection via a central or peripheral IV line using a 3-way stopcock; immediately follow with a 10 mL bolus of NS. Use with the SPY Elite or PINPOINT Fluorescence imaging systems or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of blood flow, tissue perfusion, and vessels. A visible fluorescence response in blood vessels may be seen within 5 to 15 seconds after administration.

Cardiac output determination: In the performance of dye dilution curves, administer as a single bolus as rapidly as possible via a cardiac catheter into selected sites in the vascular system. Inject the dose of dye in 1 mL volume; an average of 5 dilution curves are recommended in the procedure. Attach a recording instrument (oximeter or densitometer) to a needle or catheter for sampling of the dye-blood mixture from a systemic arterial sampling site. Use sterile water for injection to rinse the syringe; use isotonic saline to flush the residual dye from the cardiac catheter into circulation to avoid hemolysis; saline should be used in all other parts of the catheterization procedure. See manufacturer's labeling for specific information regarding calibration of dye curves.

Extrahepatic biliary ducts: Administer at least 45 minutes prior to surgery. Use with the PINPOINT Fluorescence imaging system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of extrahepatic biliary ducts. A visible fluorescence response in blood vessels may be seen within 45 minutes after administration.

Hepatic function studies: Inject into the lumen of an arm vein as rapidly as possible, without allowing the dye to escape outside the vein. If the photometric method is used, prior to injecting indocyanine green, withdraw 6 mL venous blood from the patients arm for serum blank and standard curve construction, and through the same needle, inject the correct amount of dye. Ear oximetry has also been used; see manufacturer's labeling for additional information.

Ophthalmic angiography studies: Administer as a bolus injection into the antecubital vein; immediately follow with a 5 mL bolus of normal saline.

Intradermal: Lymphatic mapping of breast cancer: Administer into the peri-areolar area at the 12 and 9 o'clock positions for the right breast or at the 12 and 3 o'clock positions for the left breast; if an additional dose is necessary, administer at the 12, 3, and 9 o'clock positions. Use with the SPY Portable Handheld Imaging (SPY-PHI) system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of breast cancer. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.

Interstitial: Lymphatic mapping of cervical and uterine cancer: Administer into the cervix at the 3 and 9 o'clock positions with a superficial (1 to 3 mm) and deep (1 to 3 cm) injection at each position for a total of 4 injections. Use with the PINPOINT Fluorescence imaging system or an FDA-approved imaging device that is specifically indicated for use with indocyanine green for fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping of cervical and uterine cancer. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.

Canadian labeling:

IV:

Blood flow and tissue perfusion imaging: Administer as a bolus injection via a central or peripheral IV line using a three-way stopcock; immediately follow with a 10 mL bolus of NS. A visible fluorescence response in blood vessels may be seen within 5 to 15 seconds after administration.

Extrahepatic biliary anatomy imaging: Administer ~45 minutes prior to surgery; a visible fluorescence response in blood vessels may be seen ~45 minutes after administration.

Interstitial: Lymph node and lymphatic vessels imaging: Administer into the cervix at the 3 and 9 o'clock positions with a superficial (1 to 3 mm) and deep (1 to 3 cm) injection at each position for a total of 4 injections while patient is under anesthesia. A visible fluorescence response in lymph nodes and lymphatic vessels may be seen within 1 minute after administration.

Administration: Pediatric

Parenteral: IV:

Blood flow, tissue perfusion, and vessel visualization: IC-Green, Spy Agent Green: Infants, Children, and Adolescents: Administer via central or peripheral vein by rapid bolus; follow immediately with NS flush (eg, 10 mL in adults). Note: The use of 2 syringes (one with indocyanine green and the other with NS flush) connected to three-way stopcock is recommended.

Extrahepatic biliary ducts imaging: IC-Green, Spy Agent Green: Children ≥12 years and Adolescents: Inject dose at least 45 minutes prior to surgery.

Ophthalmic angiography: IC-Green: Infants, Children, and Adolescents: Administer by IV injection; may use peripheral site (antecubital vein may be used); follow dose immediately with 5 mL NS flush.

Use: Labeled Indications

US labeling:

Blood flow, tissue perfusion, and vessel visualization (Spy Agent Green): Fluorescence imaging of blood flow, tissue perfusion, and vessels (eg, micro- and macro-vasculature) before, during, and after GI, organ transplant, plastic, micro and reconstructive, and vascular surgeries, (including minimally invasive surgical procedures) in adults and pediatric patients ≥1 month of age.

Cardiac/hepatic function diagnostics (IC Green): For determining cardiac output, hepatic function, and liver blood flow.

Extrahepatic biliary ducts imaging (Spy Agent Green): Fluorescence imaging of extrahepatic biliary ducts in adults and pediatric patients ≥12 years of age.

Lymphatic mapping (Spy Agent Green): Fluorescence imaging of lymph nodes and delineation of lymphatic vessels during lymphatic mapping in adults with breast, cervical, or uterine cancer for which this procedure is a component of intraoperative management.

Ophthalmic angiography (IC Green): For ophthalmic angiography.

Canadian labeling:

Diagnostic imaging:

IV administration: Fluorescence imaging of blood flow and tissue and organ perfusion during gastrointestinal, organ transplant, plastic micro and reconstructive, and vascular surgeries (includes minimally invasive surgical procedures); imaging of biliary ducts and intraoperative cholangiography when used in combination with Advanced Imaging Modality (AIM) or PINPOINT Fluorescence Imaging Systems; intraoperative fluorescence angiography with SPY Elite, SPY-PHI, Advanced Imaging Modality (AIM) and PINPOINT Fluorescence Imaging Systems.

Interstitial administration: Fluorescence imaging of lymph nodes and delineation of lymphatic vessels in the cervix and uterus during lymphatic mapping in patients with solid tumor undergoing an intraoperative procedure; used with Advanced Imaging Modality and PINPOINT Fluorescence Imaging Systems during lymphatic mapping.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Reproduction studies have not been done.

Breastfeeding Considerations

It is not known if indocyanine green is excreted in breast milk. The manufacturer recommends that caution be exercised when administering indocyanine green to nursing women.

Monitoring Parameters

Signs and symptoms of hypersensitivity.

Reference Range

Normal percentage disappearance rate is 18% to 24% per minute

Mechanism of Action

Indocyanine dye is a tricarbocyanine dye that permits recording of the indicator-dilution curves for both diagnostic and research purposes independently of fluctuations in oxygen saturation.

Pharmacokinetics (Adult Data Unless Noted)

Protein binding: 95% to 98% to albumin.

Half-life elimination: 2.5 to 3 minutes.

Excretion: Bile.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Verdye;
  • (AT) Austria: Icg pulsion;
  • (DE) Germany: Cardio green | Verdye;
  • (EE) Estonia: Aurogreen | Infracyanine;
  • (FR) France: Infracyanine;
  • (GB) United Kingdom: Cardio green | Verdye;
  • (GR) Greece: Icg pulsion;
  • (JP) Japan: Diagnogreen | Ophthagreen;
  • (KR) Korea, Republic of: Diagnogreen | Dongindang indocyanine green | Ic green;
  • (LT) Lithuania: Verdye;
  • (NL) Netherlands: Verdye;
  • (NO) Norway: Igc pulsion | Verdye orifarm;
  • (PR) Puerto Rico: Cardio green | Ic green;
  • (QA) Qatar: CellBion Green;
  • (RU) Russian Federation: Indocyanine zelenyi pulsion | Verdye;
  • (SE) Sweden: Indocyaningroen pulsion | Verdye;
  • (TH) Thailand: Diagnogreen;
  • (TW) Taiwan: Diagnogreen
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  2. Higuchi K, Nanashima A, Hiyoshi M, et al. Resected intrahepatic cholangiocarcinoma with anaphylactic shock from a preoperative liver function test before hepatectomy. Case Rep Gastroenterol. 2019;13(1):140-143. doi:10.1159/000499181 [PubMed 31097929]
  3. IC-Green (indocyanine green) [prescribing information]. Farmington Hills, MI: Diagnostic Green LLC; December 2024.
  4. IC-Green (indocyanine green) [prescribing information]. Lake Forest, IL: Akorn; March 2022.
  5. Marziali E, Testi I, MacPhee B, et al. A prospective evaluation of adverse events occurring in children undergoing fundus fluorescein and indocyanine green angiography. Eye (Lond). 2022;36(9):1837-1839. doi:10.1038/s41433-022-01951-5 [PubMed 35094031]
  6. Meira J, Marques ML, Falcão-Reis F, Rebelo Gomes E, Carneiro Â. Immediate reactions to fluorescein and indocyanine green in retinal angiography: review of literature and proposal for patient's evaluation. Clin Ophthalmol. 2020;14:171-178. doi:10.2147/OPTH.S234858 [PubMed 32021082]
  7. Refer to manufacturer's labeling.
  8. Spy Agent Green (indocyanine green) [product monograph]. Burnaby, British Columbia, Canada: Novadaq Technologies ULC; June 2023.
  9. Valikodath N, Cole E, Chiang MF, Campbell JP, Chan RVP. Imaging in retinopathy of prematurity. Asia Pac J Ophthalmol (Phila). 2019;8(2):178-186. doi:10.22608/APO.201963 [PubMed 31037876]
  10. Zhai Q, Wang Y, Tian A. Severe hemodynamic instability after indocyanine green injection during off-pump coronary artery bypass grafting: a case report. Medicine (Baltimore). 2017;96(46):e8766. doi:10.1097/MD.0000000000008766 [PubMed 29145331]
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