Pegulicianine: uses, dosing, side effects & brands
Pegulicianine is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- Lumisight
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How pegulicianine is dosed
From the FDA label for Lumisight (application NDA214511). Other pegulicianine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Pegulicianine side effects
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% unknown or unreported. Adverse reactions occurring in ≥ 1% of patients receiving LUMISIGHT were hypersensitivity (1.4%, including anaphylaxis [4 out of 726]) and chromaturia (85%). Chromaturia resolved within 48 hours…
Who shouldn’t take pegulicianine
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 )
Pegulicianine 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.
Every pegulicianine product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Lumisight.
Related calculators
Frequently asked questions
What is pegulicianine?
LUMISIGHT (pegulicianine for injection) is an optical imaging agent for intravenous use.
Can you take pegulicianine with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run pegulicianine against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does pegulicianine come in?
Across the brands we track, pegulicianine is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic pegulicianine?
We do not currently list a generic-labelled pegulicianine product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Pegulicianine: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/pegulicianine
- MLA
- “Pegulicianine: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/pegulicianine.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for pegulicianine on DailyMed (NIH) ↗ — including its boxed warning in full.