Media
What is LumiSystem™?
LumiSystem is the combination of the following FDA approved products – LUMISIGHT™ (pegulicianine) and Lumicell™ DVS. These products are used as an adjunct by surgeons to intraoperatively detect residual breast cancer, in real-time, during lumpectomy surgery.
IMPORTANT SAFETY INFORMATION
What is LUMISIGHT (pegulicianine) and Lumicell DVS?
- LUMISIGHT (pegulicianine) is an optical imaging agent and Lumicell Direct Visualization System (DVS) is a fluorescence imaging device. LUMISIGHT and Lumicell DVS, in combination, are indicated for 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.
What is the most important information I should know about LUMISIGHT?
- Hypersensitivity Reactions: LUMISIGHT may cause serious hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred in 4/726 (0.6%) of patients in clinical studies. Before LUMISIGHT 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 available during the use of LUMISIGHT. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy.
- LUMISIGHT is contraindicated in patients with a history of hypersensitivity reactions to pegulicianine.
What are the most common side effects of LUMISIGHT?
- The most common side effects (≥1%) include hypersensitivity and an abnormal color in urine.
What additional important information should I know about LUMISIGHT and Lumicell DVS?
- Adjunctive Use: Lumicell DVS is for adjunctive use and is not a replacement for the standard of care lumpectomy procedure and pathology. Before use, physicians must be trained in breast-conserving surgery and the proper use of Lumicell DVS. Lumicell DVS detection of breast cancer may not be generalizable to all subpopulations at increased risk for positive margins.
- Risk of Misdiagnosis: The absence of a signal in surgery does not rule out cancer. Additionally, a positive signal may be seen in non-cancerous tissue.
- Interference from Dyes Used for Sentinel Lymph Node Mapping: Avoid administration of dyes before imaging the lumpectomy cavity in patients who have received LUMISIGHT.
- Tissue Perforation or Damage: Avoid excessive pressure or torque with the Lumicell DVS handheld probe while inside the cavity as it can cause tissue perforation or damage.
- Infection Risk: To avoid infection risk when using reusable equipment, properly and completely disinfect and reprocess the Lumicell DVS handheld probe and cables after each use. To avoid infection risk when using sterile single-use equipment, ensure to use the Lumicell DVS sterile probe cover properly.
- Eye Discomfort: Avoid direct eye exposure to the Lumicell DVS handheld light probe as it may cause discomfort.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088. Please see the LUMISIGHT Prescribing Information, including Boxed Warning, and Lumicell DVS Instructions for Use. For complete product information www.LumiSystem.com.
