Trodelvy Description

For injection: 180 mg off-white to yellowish lyophilized powder in a single-dose vial.
Sacituzumab govitecan is a Trop-2 directed antibody and topoisomerase inhibitor conjugate, composed of the following three components: the humanized monoclonal antibody, hRS7 IgG1κ (also called sacituzumab), which binds to Trop-2 (the trophoblast cell-surface antigen-2); the drug SN-38, a topoisomerase inhibitor; a hydrolysable linker (called CL2A), which links the humanized monoclonal antibody to SN-38.
The recombinant monoclonal antibody is produced by mammalian (murine myeloma) cells, while the small molecule components SN-38 and CL2A are produced by chemical synthesis. Sacituzumab govitecan contains on average 7 to 8 molecules of SN-38 per antibody molecule. Sacituzumab govitecan has a molecular weight of approximately 160 kilodaltons.
Each single-dose vial of TRODELVY delivers 180 mg sacituzumab govitecan.
Reconstitution with 20 mL of 0.9% Sodium Chloride Injection, USP, results in a concentration of 10 mg/mL with a pH of 6.5.
Excipients/Inactive Ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrate.