Pegulicianine

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.

Pegulicianine is a prodrug that is optically inactive when intact and produces a fluorescent signal after its peptide chain is cleaved by cathepsins and matrix metalloproteases (MMPs). The levels of these enzymes are higher in and around tumor and tumor-associated cells than normal cells. This enzymatic cleavage results in “fragment 2” and “fragment 3”, which are optically active metabolites that emit fluorescence, as well as “fragment 1” containing the fluorescence quencher that keeps the intact molecule optically inactive. “Fragment 2” and “fragment 3” absorb light in the visible light region with a peak absorption at 650 nm and fluoresce with a peak emission at 675 nm.

Recommended dose of LUMISIGHT is 1 mg/kg by intravenous injection over 3 minutes administered 2 hours to 6 hours prior to imaging. See Full Prescribing Information for instructions on preparation, administration, and imaging.

LUMISIGHT is contraindicated in patients with a history of hypersensitivity reaction to pegulicianine. Reactions have included anaphylaxis. History of hypersensitivity reaction to pegulicianine.

Boxed 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. 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. Interference from Dyes Used for Sentinel Lymph Node Mapping: Avoid administration of dyes before imaging the lumpectomy cavity in patients receiving LUMISIGHT.

The following clinically important adverse reactions are described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions Most common adverse reactions (≥1%) were hypersensitivity and chromaturia.

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.

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