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Daratumumab is a human monoclonal IgG1κ antibody against CD38 antigen, produced in a mammalian cell line (Chinese Hamster Ovary [CHO]) using recombinant DNA technology.
Concentrate for solution for IV infusion: Each 5 mL vial contains 100 mg of daratumumab (20 mg daratumumab per mL).
Each 20 mL vial contains 400 mg of daratumumab (20 mg daratumumab per mL).
Excipients with known effect: Each 5 mL and 20 mL vial of DARZALEX contains 0.4 mmol and 1.6 mmol (9.3 mg and 37.3 mg) sodium, respectively.
Excipients/Inactive Ingredients: Glacial acetic acid, Mannitol (E421), Polysorbate 20, Sodium acetate trihydrate, Sodium chloride, Water for injections.
Solution for SC injection: Each 15 mL vial of solution for subcutaneous injection contains 1800 mg of daratumumab (120 mg daratumumab per mL).
Excipients with known effect: Each 15 mL vial of solution for injection contains 735.1 mg of sorbitol (E420).
Excipients/Inactive Ingredients: Recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 20, Sorbitol (E420), Water for injections.
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