Pegulicianine

Pegulicianine is a fluorescence-guided system indicated for imaging in adults with breast cancer as an adjunct for intraoperative detection of cancerous tissue within the resection cavity following the removal of the primary specimen during lumpectomy surgery.

• Pegulicianine is available under the following different brand names: Lumisight.

Common side effects of Pegulicianine include:

• hypersensitivity 
• chromaturia

Serious side effects of Pegulicianine include:

• anaphylaxis and other serious hypersensitivity reactions

Rare side effects of Pegulicianine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, of lyophilized powder for reconstitution

• 39 mg/vial

Tumor imaging

Adult dosage

• 1 mg/kg (actual body weight) IV injection over 3 minutes administered 2-6 hours before imaging

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pegulicianine has no noted severe interactions with any other drugs
• Pegulicianine has no noted serious interactions with any other drugs
• Pegulicianine has no noted moderate interactions with any other drugs
• Pegulicianine has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of hypersensitivity reaction to Pegulicianine, including anaphylaxis

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pegulicianine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pegulicianine?”

Cautions

• Serious hypersensitivity
  • Prepare for the possibility of drug hypersensitivity reactions (including anaphylaxis), which can occur during or following administration
  • Have emergency resuscitation drugs, equipment, and trained personnel available
  • If a hypersensitivity reaction is suspected, immediately discontinue injection and initiate appropriate therapy
• Risk of misdiagnosis
  • False positive and false negative findings may occur during use to detect residual cancer
  • Absence of signal in lumpectomy cavity does not rule out the presence of residual cancer
  • Additionally, a positive signal has been observed in some noncancerous tissue
• Drug interaction overview
  • Dyes
    • Before imaging the lumpectomy cavity, avoid administration of dyes used for sentinel lymph node (SLN) mapping procedures
    • Blue dyes used for SLN mapping procedures generate a fluorescent signal that interferes with the Pegulicianine signal when injected into the breast before imaging
    • The potential of other dyes to interfere with Pegulicianine imaging has not been evaluated

Pregnancy and Lactation

• Data are not available regarding use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • Data are not available on the presence of Pegulicianine or its metabolites in either human or animal milk, its effects on breastfed infants, or its effects on milk production