General MedicationsINTRAVENOUSBlack Box

LUMISIGHT

PEGULICIANINE

Standard Dose

2 DOSAGE AND ADMINISTRATION Recommended dose of LUMISIGHT is 1 mg/kg by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging. ( 2.1 ) See Full Prescribing Information for instructions on preparation, administration, and imaging. ( 2.2 , 2.3 , 2.4 ) 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 Calculate the dose (1 mg/kg) and the total volume (mL) of LUMISIGHT based on the individual patient’s weight. Obtain the number of vials required to administer the patient dose. Allow the vials to acclimate to room temperature between 20°C to 25°C (68°F to 77°F) for approximately 5 minutes. 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. 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. 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. 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.

Max Dose

See official label

Primary Use

1 INDICATIONS AND USAGE LUMISIGHT is 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.

Summary

LUMISIGHT is 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. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended dose of LUMISIGHT is 1 mg/kg by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging. ( 2.1 ) See Full Prescribing Information for instructions on preparation, administration, and imaging. ( 2.2 , 2.3 , 2.4 ) 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).

Structured Monograph

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE LUMISIGHT is 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 is 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. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION Recommended dose of LUMISIGHT is 1 mg/kg by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging. ( 2.1 ) See Full Prescribing Information for instructions on preparation, administration, and imaging. ( 2.2 , 2.3 , 2.4 ) 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 Calculate the dose (1 mg/kg) and the total volume (mL) of LUMISIGHT based on the individual patient’s weight. Obtain the number of vials required to administer the patient dose. Allow the vials to acclimate to room temperature between 20°C to 25°C (68°F to 77°F) for approximately 5 minutes. 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. 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. 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. 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Risk of Misdiagnosis : Absence of signal in the surgical field does not rule out the presence of cancer. Positive signal may be seen in non-cancerous tissue. ( 5.2 ) Interference from Dyes Used for Sentinel Lymph Node Mapping : Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT. ( 5.3 , 7 ) 5.1 Anaphylaxis and Other Serious Hypersensitivity Reactions Prepare for the possibility of drug hypersensitivity reactions (including anaphylaxis), which can occur during or following administration, and take the necessary precautions. In clinical studies, 4 of 726 (0.6%) patients treated with LUMISIGHT experienced signs and symptoms consistent with anaphylaxis. The onset was during administration in three patients. 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 [see Adverse Reactions ( 6.1 )]. Before LUMISIGHT administration, assess all p

Boxed Warning

WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration of LUMISIGHT. 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 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 promptly available. 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 [see Warning and Precautions (5.1) ] . WARNING: ANAPHYLAXIS AND OTHER SERIOUS HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Serious hypersensitivity reactions, including anaphylaxis, can occur during or following administration. 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. Monitor all patients for hypersensitivity reactions. If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. ( 5.1 ).

Monitoring

• 5 WARNINGS AND PRECAUTIONS Risk of Misdiagnosis : Absence of signal in the surgical field does not rule out the presence of cancer.
• Positive signal may be seen in non-cancerous tissue.
• ( 5.2 ) Interference from Dyes Used for Sentinel Lymph Node Mapping : Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT.
• ( 5.3 , 7 ) 5.1 Anaphylaxis and Other Serious Hypersensitivity Reactions Prepare for the possibility of drug hypersensitivity reactions (including anaphylaxis), which can occur during or following administration, and take the necessary precautions.

Interaction Notes

• 7 DRUG 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 LUMISIGHT imaging has not been evaluated.
• Avoid administration of dyes used for SLN mapping procedure before imaging the lumpectomy cavity in patients receiving LUMISIGHT.