Pronunciation:

in-doe-SYE-a-neen green

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Diagnostic Agent, Cardiac Function

Uses of This Medicine:

Indocyanine green injection is a medical dye used in tests to help determine the cardiac (heart) output, liver function, and blood flow in the liver. It is also used to help certain parts of the eye to become more visible during medical procedures such as angiography.

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

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of IC-Green® in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Spy Agent™ Green in children 1 month of age and older for images of blood vessels and blood flow, or in children 12 years and older for images of the bile ducts. Safety and efficacy have not been established in children younger than 1 month of age to see images of the blood vessels or blood flow, in children younger than 12 years to see images of the bile ducts, and in children to see images of the lymph nodes in the breast, cervix, or uterus.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of indocyanine green injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress to make sure this medicine is working properly and to check for unwanted effects.

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

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

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 occur in some patients. If you notice any other effects, check with your healthcare professional.

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