ProstaScint
Generic name: capromab pendetide
Dosage form: injection
Drug class:Radiologic conjugating agents
Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.
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DESCRIPTION
ProstaScint® (capromab pendetide) is the murine monoclonal antibody, 7E11-C5.3, conjugated to the linker-chelator, glycyl-tyrosyl-(N, ε-diethylenetriaminepentaacetic acid)-lysine hydrochloride (GYK-DTPA-HCl). The 7E11-C5.3 antibody is of the IgG1, kappa subclass (IgG1κ). This antibody is directed against a glycoprotein expressed by prostate epithelium known as Prostate Specific Membrane Antigen (PSMA). The PSMA epitope recognized by monoclonal antibody (MAb) 7E11-C5.3 is located in the cytoplasmic domain. Expression of this glycoprotein has not been demonstrated on any other adenocarcinomas or transitional cell cancers tested. The antibody is produced by serum-free in vitro cultivation of cells, and purified by sequential protein isolation and chromatographic separation procedures.
Each ProstaScint® kit consists of two vials which contain all of the non-radioactive ingredients necessary to produce a single unit dose of Indium In 111 ProstaScint®, an immunoscintigraphic agent for administration by intravenous injection only. The ProstaScint® vial contains 0.5 mg of capromab pendetide in 1 mL of sodium phosphate buffered saline solution adjusted to pH 6; a sterile, pyrogen-free, clear, colorless solution that may contain some translucent particles. The vial of sodium acetate buffer contains 82 mg of sodium acetate in 2 mL of Water for Injection adjusted to pH 5-7 with glacial acetic acid; it is a sterile, pyrogen-free, clear, and colorless solution. Neither solution contains a preservative. Each kit also includes one sterile 0.22 μm Millex® GV filter, prescribing information, and two identification labels.
The sodium acetate solution must be added to the sterile, non-pyrogenic high purity Indium In 111 Chloride solution to buffer it prior to radiolabeling ProstaScint®. The immunoscintigraphic agent Indium In 111 Capromab Pendetide (Indium In 111 ProstaScint®) is formed after radiolabeling with Indium In 111.
