LUMISIGHT Solution for injection Ref.[109593] Active ingredients: Pegulicianine

Source: FDA, National Drug Code (US)  Revision Year: 2024 

Product description

LUMISIGHT (pegulicianine for injection) is an optical imaging agent for intravenous use.

The chemical name of pegulicianine acetate is N-[6-(1-{2-[3,6-bis(2,3-dihydro-1H-indol-1-yl)xanthylium-9-yl]benzene-1-sulfonyl}piperidine-4-carboxamido)hexanoyl]glycylglycyl-L-arginyl-N6-(6-{2-[(1E,3E,5Z)5(1-ethyl-3,3-dimethyl-5-sulfonato-1,3-dihydro-2H-indol-2-ylidene)penta-1,3-dien-1-yl]-3,3-dimethyl-5-sulfonato-3H-indol-1-ium-1-yl}hexanoyl)Llysyl[2-(2-aminoethoxy)ethoxy]acetyl-S-[(3RS)1{6-[α-methylpoly(oxyethylene)-ω-amino]-6-oxohexyl}-2,5-dioxopyrrolidin-3-yl]-Lcysteinamide acetate with a molecular formula of C116H147N19O23S4(C2H4O)n, with n of approximately 450, a molecular weight of 20-25 kDa, and the following structural formula:

Figure 1. Molecular structure of pegulicianine acetate:

LUMISIGHT is supplied as a sterile, dark blue lyophilized powder. Each vial contains 40 mg of pegulicianine (equivalent to 40.1 mg of pegulicianine acetate) and the following inactive ingredients: 3.2 mg of dibasic sodium phosphate heptahydrate, 39.5 mg of mannitol, and 3.8 mg of monobasic sodium phosphate monohydrate to permit withdrawal of 3.9 mL of pegulicianine 10 mg/mL upon reconstitution with 4 mL of 0.45% sodium chloride injection, USP. The pH of the reconstituted solution is 6 to 7.

Dosage Forms and Strengths

For injection: dark blue lyophilized powder in a single-dose vial delivering 39 mg pegulicianine after reconstitution.

How Supplied

LUMISIGHT (pegulicianine) for injection is supplied as a dark blue lyophilized powder for reconstitution in a clear, glass single-dose vial in cartons of 10 vials (NDC 82292-040-10). After reconstitution, each vial delivers 39 mg pegulicianine.

Manufactured for: Lumicell, Inc., 275 Washington Street, Suite 200, Newton, MA 02458

Drugs

Drug Countries
LUMISIGHT United States

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