Lumisight Drug Information
Generic name: PEGULICIANINE
Uses of 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.
Dosage & Administration of Lumisight
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.
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.
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.
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 . 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.
Side Effects of Lumisight
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LUMISIGHT was evaluated in 726 patients who received a single dose of 1 mg/kg of LUMISIGHT. Among these 726 patients, 703 (97%) had breast cancer and 23 (3%) had other types of cancer. The mean age of the patients was 62 years (range: 36 years to 95 years), and 98% of them were female.
Distribution by race was 82% White, 7% Black or African American, 6% Asian, and 5% other or unreported. Distribution by ethnicity was 3% Hispanic/Latino, 93% non-Hispanic/Latino, and 4% unknown or unreported. Adverse reactions occurring in ≥ 1% of patients receiving LUMISIGHT were hypersensitivity (1.4%, including anaphylaxis ) and chromaturia (85%). Chromaturia resolved within 48 hours after administration in 93% of patients, with the longest time to resolution of 15 days.
Adverse reactions occurring in use < 1% of patients were skin discoloration after extravasation, nausea, dyspnea, pyrexia, and vomiting.
Warnings & Cautions for Lumisight
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. Before LUMISIGHT administration, assess all patients for any history of hypersensitivity reaction to contrast media or products containing polyethylene glycol (PEG), as these patients may have an increased risk for hypersensitivity reaction to LUMISIGHT. In clinical studies, three out of four patients that experienced anaphylaxis did not have a history of hypersensitivity reaction to contrast media or products containing PEG. Always have emergency resuscitation drugs, equipment, and trained personnel available. Monitor all patients for hypersensitivity reactions through symptom reporting, direct observation, and vital sign measurements.
If a hypersensitivity reaction is suspected, immediately discontinue the injection and initiate appropriate therapy. LUMISIGHT is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine .
Risk of Misdiagnosis False positive and false negative findings may occur during
use of LUMISIGHT to detect residual cancer. Absence of signal in the lumpectomy cavity does not rule out the presence of residual cancer. Additionally, positive signal has been observed in some non-cancerous tissue.
Interference from Dyes Used for Sentinel Lymph Node Mapping Blue dyes used
for sentinel lymph node (SLN) mapping procedures interfere with LUMISIGHT imaging. The potential of other dyes to interfere with LUMISIGHT imaging has not been evaluated. Avoid administration of dyes used for SLN mapping procedures before imaging the lumpectomy cavity in patients receiving LUMISIGHT.
Drug Interactions with Lumisight
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.
Contraindications for Lumisight
is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine. Reactions have included anaphylaxis . History of hypersensitivity reaction to pegulicianine.
Clinical Studies of Lumisight
The efficacy and safety of LUMISIGHT for the intraoperative detection of cancerous tissue within the resection cavity following removal of the primary specimen during lumpectomy surgery in patients with breast cancer were evaluated in a randomized, multicenter, intra-patient controlled clinical trial NCT03686215. A total of 406 adult patients with confirmed invasive breast cancer, ductal carcinoma in situ (DCIS), or both received 1 mg/kg LUMISIGHT by intravenous injection 2 hours to 6 hours prior to imaging with the Lumicell DVS. Among them, 357 patients underwent LUMISIGHT-guided imaging after completion of the standard of care lumpectomy procedure. Patients who received neoadjuvant chemotherapy or radiotherapy prior to surgery were excluded from study. After the standard of care (SOC) lumpectomy was completed, the lumpectomy cavity was divided into six regions based on anatomic orientation and each region was imaged with the Lumicell DVS. When positive fluorescence signal was detected, the tissue was resected with a cavity shave procedure and the region was re-imaged.
A maximum of two LUMISIGHT-guided shaves were obtained from a single region. Histopathology analysis of excised tissue served as the reference standard. Cavity regions that did not have a LUMISIGHT-guided cavity shave or tissue from a second surgery for a reference standard were assigned the margin status of the corresponding outermost surface of the lumpectomy specimen or SOC cavity shave, with a positive margin defined as tumor on ink for invasive cancers (with or without DCIS) or within 2 mm of the inked margin for DCIS alone.
The mean age of patients was 62 years (range: 36 years to 83 years). Distribution by race was 82% White, 7% Black or African American, 6% Asian, and 5% other. Distribution by ethnicity was 3% Hispanic/Latino, 94% non-Hispanic/Latino, and 3% unknown or unreported. In the study group, 70% of patients had invasive ductal carcinoma (with or without DCIS), 20% had DCIS only, 10% had invasive lobular carcinoma (with or without DCIS), and <1% had both invasive ductal and invasive lobular carcinoma.
The study assessed the proportion of patients receiving LUMISIGHT who had residual cancer detected and removed using the Lumicell DVS after completion of SOC lumpectomy. One hundred and sixty-six of 357 (46%) patients had at least one LUMISIGHT-guided shave. A total of 27 of 357 patients had residual cancer confirmed by histopathology in at least one LUMISIGHT-guided shave (7.6%; 95% CI: 5.0%, 10.8%). Table 1 shows sensitivity and specificity of LUMISIGHT for residual breast cancer after completion of SOC lumpectomy calculated from the 2,346 evaluable images in the study.
Regions of the lumpectomy cavity from which LUMISIGHT-guided shaves were taken contributed more than one image to the analysis. A total of 155 of 357 (43%) patients had at least one false positive image, and 28 of 357 (8%) patients had at least one false negative image. Among the 166 patients with at least one LUMISIGHT-guided shave, the mean total LUMISIGHT-guided shave volume was 22 cm 3 ± 20 cm 3, accounting for 20% ± 15% of the total volume of resection.
After completion of SOC lumpectomy, prior to LUMISIGHT-guided tissue removal, 62 of 357 patients (17%) had at least one cancer-positive margin. After LUMISIGHT-guided surgery, 9 of these 62 (15%) patients changed to having all cancer-negative margins, and 2 of the remaining 295 (1%) patients changed from having all cancer-negative margins to having at least one cancer-positive margin. table1
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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