DECNUPAZ Powder for solution for injection Ref.[116689] Active ingredients: Pivekimab sunirine

Pivekimab sunirine-pvzy is a CD123-directed antibody and alkylating agent conjugate created by conjugating the IgG1 monoclonal antibody G4723A to the DGN549C linker-payload. The antibody-drug conjugate (ADC) contains approximately two DGN549C molecules sulfonated prior to conjugation and bound to the heavy chains (HC) of the G4723A antibody. Pivekimab sunirine-pvzy has an approximate molecular weight of 148 kDa. Pivekimab sunirine-pvzy is produced by site directed chemical conjugation of the antibody and small molecule components. The antibody is produced by mammalian (Chinese hamster ovary) cells, and the small molecule components are produced by chemical synthesis.

Pivekimab sunirine-pvzy has the following structure:

DECNUPAZ (pivekimab sunirine-pvzy) for injection is a sterile, lyophilized cake in a single-dose vial for reconstitution and dilution. DECNUPAZ is supplied as 2 mg per vial and requires reconstitution with Sterile Water for Injection, USP (1.1 mL) to obtain a concentration of 2 mg/mL. Following reconstitution, each mL delivers 2 mg of pivekimab sunirine-pvzy, methionine (0.45 mg), polysorbate 20 (0.1 mg), sodium hydroxide (0.2 mg), sodium metabisulfite (0.0048 mg), succinic acid (1.2 mg), trehalose (71.7 mg), and Sterile Water for Injection. The pH is 4.2.