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Padcev is supplied as single-dose vials containing sterile, preservative-free, white to off-white lyophilized powder for reconstitution for intravenous infusion.
Each vial contains either 20 mg or 30 mg enfortumab vedotin active ingredient that is reconstituted to a final concentration of 10 mg/mL.
Enfortumab vedotin is an antibody-drug conjugate (ADC) comprised of a Nectin-4 directed, fully human Chinese Hamster Ovary (CHO)-expressed IgG1-kappa monoclonal antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline (vc) linker.
Excipients/Inactive Ingredients: Histidine, Histidine hydrochloride monohydrate, Trehalose dihydrate, Polysorbate 20.
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