Lumisight

Generic name: pegulicianine
Dosage form: Intravenous injection

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 2, 2024.

What is Lumisight?

Lumisight is a fluorescent imaging drug used during breast cancer surgery to help identify cancerous tissue during lumpectomy surgery to remove the primary cancer specimen. When Lumisight is around or in tumor cells, it fluoresces, which is then seen on an imaging device such as the Lumicell Direct Visualization System (DVS). Any tissue that is detected as cancer can be removed during surgery which may achieve a more complete removal of cancer tissue.

When Lumisight and Lumicell DVS are used together, they are known as LumiSystem.

Lumisight became a FDA approved medicine on 17 April 2024 as an optical imaging agent indicated for fluorescence imaging in adults with breast cancer as an adjunct for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery.

Lumisight side effects

The most common Lumisight side effect is abnormal urine color (85%), which usually resolves within 48 hours. Hypersensitivity reactions affected 1.4% of patients, this included anaphylaxis, which affected 0.55% of patients in clinical trials.

Lumisight side effects that affected 1% or less of patients were nausea, shortness of breath, fever, vomiting, and skin discoloration after extravasation.

Warning

Lumisight may cause serious hypersensitivity reactions, including anaphylaxis, in 0.55% of patients.

Before Lumisight administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG). Emergency resuscitation drugs, equipment, and trained personnel promptly should always be available. All patients should be monitored for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and start appropriate therapy.

Lumisight is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.

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.

Who should not use Lumisight?

You should not use Lumisight if you have a history of hypersensitivity reaction to pegulicianine.

Before taking this medicine

Pregnancy

Tell your healthcare provider if you are pregnant or planning a pregnancy. There are no available data on pegulicianine use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Animal reproduction studies were not conducted with pegulicianine.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. There are no data on the presence of pegulicianine or its metabolites in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lumisight and any potential adverse effects on the breastfed infant from Lumisight or from the underlying maternal condition.

How will I receive Lumisight?

Lumisight is given as an intravenous injection (IV) over 3 minutes. It is administered 2 to 6 hours before imaging.

Dosing information

The recommended dose of Lumisight is 1mg/kg of actual body weight.

Interactions

Blue dyes used for SLN mapping procedures generate a fluorescent signal that interferes with the signal from Lumisight when injected into the breast prior to imaging with Lumisight. The potential of other dyes to interfere with this imaging medicine has not been evaluated. Avoid administration of dyes used for SLN mapping procedure before imaging the lumpectomy cavity in patients receiving this imaging medicine.

Tell your doctor about all your other medicines. Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store vials frozen at -25°C to -15°C (-13°F to 5°F) in the original carton to protect from light.

Ingredients

Active ingredient pegulicianine acetate

Inactive ingredients: 3.2 mg of dibasic sodium phosphate heptahydrate, 39.5 mg of mannitol, and 3.8 mg of monobasic sodium phosphate monohydrate to permit withdrawal of 3.9 mL of pegulicianine 10 mg/mL upon reconstitution with 4 mL of 0.45% sodium chloride injection, USP. The pH of the reconstituted solution is 6 to 7.