Lumisight

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 )

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 )

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 )].