Pronunciation:

peg-ue-LIK-i-a-neen

Brand Names:

• Lumisight

Dosage Forms:

• Powder for Solution

Warnings:

Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration of pegulicianine. Anaphylaxis occurred in 4/726 (0.6%) of patients in clinical studies. Signs and symptoms associated with other hypersensitivity reactions included pruritus, urticaria, hypotension, lip swelling, erythema, anxiety, chest pain, cyanosis, dizziness, dyspnea, headache, hypoesthesia, hyperventilation, maculopapular rash, nausea, paresthesia, visual changes, and vomiting. Before administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). Always have emergency resuscitation drugs, equipment, and trained personnel promptly available. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. Pegulicianine is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine .

Classifications:

Therapeutic—

Diagnostic Agent, Radiological Contrast Media

Uses of This Medicine:

Pegulicianine injection is an imaging agent used to help find remaining cancer tissues after removal of primary specimen during lumpectomy breast surgery.

This medicine is to be given only by or under the direct supervision of a doctor with specialized training in Lumicell Direct Visualization System (DVS) or other fluorescence imaging systems.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 pegulicianine injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pegulicianine injection in the elderly.

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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to pegulicianine, history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. This medicine is given through an IV catheter that is placed in one of your veins. It must be given slowly, so the IV will have to remain in place for at least 3 minutes. You will receive this medicine 2 to 6 hours before the imaging procedure.

Precautions While Using This Medicine:

It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have anxiety, bluish color of the fingernails, lips, skin, or nail beds, blurred vision, burning, itching, numbness, prickling, "pins and needles", or tingling, chest pain or tightness, confusion, cough, difficulty swallowing, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, fast heartbeat, hives, itching, skin rash, nausea, numbness of the feet, hands, and around the mouth, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, sweating, trouble breathing, unusual tiredness or weakness, or vomiting.

This medicine may cause your urine to turn blue. Your urine should return to normal color within 48 hours.

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:

Less common

Chest tightness

cough

difficulty swallowing

dizziness

fast heartbeat

hives, itching, skin rash

puffiness or swelling of the eyes, face, lips, or tongue

trouble breathing

unusual tiredness or weakness

Rare

Bluish color of the fingernails, lips, skin, or nail beds

blurred vision

burning, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

chest pain

confusion

deep or fast breathing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

flushing, redness of the skin

headache

lip swelling

numbness of the feet, hands, and around the mouth

rash with flat lesions or small raised lesions on the skin

sweating

unusually warm skin

vomiting

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.