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Spy Agent Green (indocyanine green)
Australian Prescription Medicine Decision Summary
Sponsor
Device/Product name
Spy Agent Green
Active Ingredient
Indocyanine green
Date of decision
Published
Submission type
New chemical entity
Decision
Approved
What steps were involved in the decision process
Registration timeline
The following table summarises the key steps and dates for this application.
Description | Date |
|---|---|
Submission dossier accepted and first round evaluation commenced
| 2 August 2021
|
Delegate’s Overall benefit-risk assessment | 10 March 2023
|
Registration decision (Outcome) | 19 February 2024
|
Completion of administrative activities and registration on ARTG | 28 February 2024
|
Number of working days from submission dossier acceptance to registration decision* | 128
|
*Statutory timeframe for standard applications is 255 working days
Date of entry onto ARTG
Black triangle scheme
Yes
Dose forms
Powder for injection
Strength
25 mg/20 mL
Containers
Vial
Pack sizes
One and 6
Routes of administration
Intravenous and interstitial
Dosage
Spy Agent Green is for intravenous and interstitial administration according to the indication.
Visualisation of vessels, blood flow and tissue perfusion
Adults:
The recommended dose of Spy Agent Green for a single image sequence is 1.25 mg to 5 mg of a 2.5 mg/mL solution.
For visualisation of perfusion in extremities through the skin, the recommended dose is 3.75 mg to 10 mg of a 2.5 mg/mL solution.
Immediately flush with a 10 mL bolus of 0.9% sodium chloride.
Paediatric population:
The recommended dose for a single image sequence is 1.25 mg to 5 mg Spy Agent Green of a 2.5 mg/mL solution. Lower doses may be administered in younger patients and in those with lower body weight. Immediately flush with bolus. Adjust the amount and type of flush to avoid volume and/or sodium overload.
Additional doses may be administered to obtain imaging sequences during the procedure. Do not exceed the maximum total dose of 2 mg/kg.
Visualisation of extrahepatic biliary ducts
The recommended single dose of Spy Agent Green for adults and paediatric patients aged 12 years of age and above is 2.5 mg of a 2.5 mg/mL solution administered intravenously as a single dose at least 45 minutes prior to surgery. Additional doses may be administered to obtain imaging sequences during the procedure.
Do not exceed a total dose of 2 mg/kg.
Visualisation of lymph nodes and lymphatic vessels during lymphatic mapping for cervical and uterine tumours
The recommended single dose of Spy Agent Green is 5 mg of a 1.25 mg/mL solution (four 1 mL injections administered interstitially into the cervix).
For further information refer to the Product Information.
Pregnancy category
B2
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. The pregnancy database must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your state or territory.
What was approved
Spy Agent Green (indocyanine green) was approved for the following therapeutic use:
For fluorescence imaging use only.
Spy Agent Green (indocyanine green) is an imaging agent (dye) intended for:
1. Visualisation of vessels, blood flow and tissue perfusion in adults and paediatric patients from one month of age and above.
2. Visualisation of extrahepatic biliary ducts in adults and children from 12 years of age and above.
3. Visualisation of lymph nodes and lymphatic vessels in women with cervical or uterine solid tumours for which lymphatic mapping is a component of intraoperative management.
Visualisation with Spy Agent Green requires an imaging system that has been validated for fluorescence imaging with indocyanine green.
What is this medicine and how does it work
When bound to proteins in plasma or in lymph fluid, indocyanine green absorbs light in the near-infrared region at 805 nm and emits fluorescence (light) at a slightly longer wavelength, with peak emission at 830 nm. Fluorescence imaging devices provide external energy as near infrared light for indocyanine green to absorb, resulting in excitation of the indocyanine green and the emitted light (fluorescence) is transferred from the field of view to an image on a monitor. These optical properties of indocyanine green are utilised in fluorescence imaging of the micro and macro vasculature, blood flow and tissue perfusion, the extrahepatic biliary ducts, and for lymphatic mapping of lymph nodes and lymphatic vessels.
What post-market commitments will the sponsor undertake
Spy Agent Green (indocyanine green) is to be included in the Black Triangle Scheme. The PI [Product Information] and CMI [Consumer Medicine Information] for Spy Agent Green must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
More information
The latest Product Information (PI) and Consumer Medicine Information (CMI) can be found by searching the Australian Register of Therapeutic Goods (ARTG).
Australian Public Assessment Reports (AusPARs) can be found by searching our AusPAR dataset.
The latest news and updates regarding therapeutic goods regulation can be found on our news page.