Indocyanine green (Interstitial, Intradermal, Intravenous)

Indocyanine green injection is a medical dye used in tests to help find out how well the heart is working, how the liver is functioning, and how blood flows in the liver. It is also used to make certain parts of the eye clearer during medical procedures like angiography.

Indocyanine green injection is also used to help diagnose or locate issues in your blood vessels, blood flow, and tissue perfusion before, during, and after surgery or transplant, as well as in bile ducts or lymph nodes and lymph vessels in the breast, cervix, or uterus in women with solid tumors.

This medicine should only be given by or under the supervision of your doctor.

It is very important for your doctor to monitor your or your child's progress to ensure this medicine is working properly and to check for any unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical attention. Contact your doctor right away if you experience a rash, itching, swelling of the face, tongue, and throat, difficulty breathing or swallowing, or chest pain after receiving this medicine.

Make sure any doctor or dentist who treats you is aware that you are receiving this medicine. This medicine may change the results of certain medical tests.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a decision you will make together with your doctor. For this medicine, here are some important points to consider:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies done to see how age affects the use of IC-Green® in children. Safety and effectiveness have not been proven.

Studies so far have not shown any specific problems in children that would limit the use of Spy Agent™ Green in children 1 month of age and older for imaging blood vessels and blood flow, or in children 12 years and older for imaging the bile ducts. Safety and effectiveness have not been established in children younger than 1 month of age for imaging blood vessels or blood flow, in children younger than 12 years for imaging the bile ducts, and in children for imaging the lymph nodes in the breast, cervix, or uterus.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the use of indocyanine green injection in older adults. However, elderly patients are more likely to have age-related liver, kidney, or heart issues, which may require caution and a dose adjustment for patients taking this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases two different medicines can be used together even if there may be an interaction. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Allergy to iodides, history of—Should not be given to patients with this condition. This medicine contains iodine or sodium iodide, which may increase the risk of allergic reactions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Chest tightness
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives or welts, itching, skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• unusual tiredness or weakness

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Diagnostic Agent, Cardiac Function

Your doctor or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins or under your skin in the breast area. Spy Agent™ Green may also be injected into a space (interstitial) in the cervix.