Clear to slightly opalescent colourless to yellow solution, essentially free from visible particles.
One vial of 10 mL concentrate for solution for infusion contains 500 mg of dostarlimab.
Each mL of concentrate for solution for infusion contains 50 mg of dostarlimab.
Dostarlimab is an anti-programmed cell death protein-1 (PD-1) immunoglobulin G4 (IgG4) humanised monoclonal antibody (mAb), produced by recombinant DNA technology in mammalian Chinese hamster ovary (CHO) cells.
The concentrate for solution for infusion has a pH of approximately 6.0 and an osmolality of approximately 300 mOsm/kg.
Excipients/Inactive Ingredients: Trisodium citrate dihydrate, Citric acid monohydrate, L-arginine hydrochloride, Sodium chloride, Polysorbate 80, Water for injection.