LUMISIGHT 10 mg/mL
Pegulicianine · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Lumicell, Inc.
LUMISIGHT is a injection, powder, lyophilized, for solution containing pegulicianine at 10 mg/mL, taken intravenous. Manufactured by Lumicell, Inc..
Key Facts
- Brand Name
- LUMISIGHT
- Generic Name
- Pegulicianine
- NDC Code (Product)
82292-040- Manufacturer
- Lumicell, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA214511
- Marketing Start
- 04/17/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 temperatur…
Contraindications
4 CONTRAINDICATIONS LUMISIGHT is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine. Reactions have included anaphylaxis [see Warning and Precautions (5.1) ] . History of hypersensitivity reaction to pegulicianine. ( 4 )
Drug Interactions
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.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically important adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (≥1%) were hypersensitivity and chromaturia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lumicell at 1-833-458-6387 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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% u…
Frequently Asked Questions
What is LUMISIGHT used for?
LUMISIGHT contains Pegulicianine. It is a injection, powder, lyophilized, for solution taken intravenous. Consult your doctor for specific uses.
Is LUMISIGHT a controlled substance?
LUMISIGHT is not classified as a controlled substance by the DEA.
What is the generic name for LUMISIGHT?
The generic name for LUMISIGHT is Pegulicianine. There are no other listed brand versions of Pegulicianine.
What is the NDC code for LUMISIGHT 10 mg/mL?
The NDC (National Drug Code) for LUMISIGHT 10 mg/mL is 82292-040, listed by Lumicell, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)