LUMISIGHT Solution for injection Ref.[109593] Active ingredients: Pegulicianine

2.1 Recommended Dose

The recommended dose of LUMISIGHT is 1 mg/kg actual body weight by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging.

2.2 Preparation of LUMISIGHT

Important Preparation Information:

• Prior to reconstitution, store vials in the freezer at -25°C to -15°C (-13°F to 5°F). Protect from light.
• Use aseptic technique for the preparation of LUMISIGHT.
• The recommended dose depends on the individual patient’s weight. Multiple vials of LUMISIGHT may need to be reconstituted to achieve the individual patient dose.
• Only use 0.45% Sodium Chloride Injection, USP for reconstitution of LUMISIGHT to prevent high osmolality.

Preparation Instructions:

1. Calculate the dose (1 mg/kg) and the total volume (mL) of LUMISIGHT based on the individual patient’s weight.
2. Obtain the number of vials required to administer the patient dose.
3. Allow the vials to acclimate to room temperature between 20°C to 25°C (68°F to 77°F) for approximately 5 minutes.
4. Reconstitute each vial of LUMISIGHT with 4 mL of 0.45% Sodium Chloride Injection, USP to permit withdrawal of 3.9 mL of LUMISIGHT 10 mg/mL.
5. Visually inspect the reconstituted solution. It should be a clear, dark blue-colored solution free of particulate matter. Discard if there is any discoloration or particulate matter.
6. If not immediately used, store the reconstituted LUMISIGHT vial at room temperature at 20°C to 25°C (68°F to 77°F) and use within 4 hours, or store the reconstituted LUMISIGHT vial in the refrigerator at 2°C to 8°C (35°F to 46°F) and use within 24 hours. Protect from light.
7. Each vial of LUMISIGHT is for a single dose. Discard unused portion.

2.3 Administration

• Withdraw the calculated volume from the appropriate number of vials into one syringe for administration of one single dose of 1 mg/kg. Verify that the syringe contains the intended volume.
• Prior to administration of LUMISIGHT, flush the peripheral intravenous (IV) line with 10 mL to 20 mL of 0.9% Sodium Chloride Injection, USP.
• Administer LUMISIGHT as an IV injection over 3 minutes beginning 2 hours to 6 hours prior to imaging with the Lumicell DVS.
• After administration of LUMISIGHT, flush the IV line with 10 mL to 20 mL of 0.9% Sodium Chloride Injection, USP.

2.4 Imaging

LUMISIGHT is used with the Lumicell Direct Visualization System (DVS) or other fluorescence imaging device that is FDA-approved for specific use with pegulicianine in the indicated population. The device provides illumination to excite the fluorescent components of pegulicianine and collects images showing pegulicianine’s fluorescence emission. Regions suspected to contain cancerous tissue are highlighted as positive signals on the Lumicell DVS display [see Clinical Studies (14)].

Training on the use of the device is essential prior to employing the system in a lumpectomy procedure. Please refer to the device labeling for details on how to use the device and for training information.

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