Urinary Bladder Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="ID_22ca85a4-1b65-47fe-84a5-1e4fea569ed8"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION </h1><p class="First">Enfortumab vedotin-ejfv is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a fully human anti-Nectin-4 IgG1 kappa monoclonal antibody (AGS-22C3) conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline (vc) linker (SGD-1006). Conjugation takes place on cysteine residues that comprise the interchain disulfide bonds of the antibody to yield a product with a drug-to-antibody ratio of approximately 3.8:1. The molecular weight is approximately 152 kDa. </p><div class="Figure"><a name="id-1035042822"></a><img alt="Enfortumab vedotin structural formula" src="image-01.jpg"/><p class="MultiMediaCaption">Figure 1. Structural Formula</p></div><p>Approximately 4 molecules of MMAE are attached to each antibody molecule. Enfortumab vedotin-ejfv is produced by 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. </p><p>PADCEV (enfortumab vedotin-ejfv) for injection is provided as a sterile, preservative-free, white to off-white lyophilized powder in single-dose vials for intravenous use. PADCEV is supplied as a 20 mg per vial and a 30 mg per vial and requires reconstitution with Sterile Water for Injection, USP, (2.3 mL and 3.3 mL, respectively) resulting in a clear to slightly opalescent, colorless to slightly yellow solution with a final concentration of 10 mg/mL <span class="Italics">[see Dosage and Administration (<a href="#ID_709893c6-5a76-4ba9-bae8-a7c09e22c869">2.3</a>)].</span> After reconstitution, each vial allows the withdrawal of 2 mL (20 mg) and 3 mL (30 mg). Each mL of reconstituted solution contains 10 mg of enfortumab vedotin-ejfv, histidine (1.4 mg), histidine hydrochloride monohydrate (2.31 mg), polysorbate 20 (0.2 mg) and trehalose dihydrate (55 mg) with a pH of 6.0. </p></section>

PADCEV

Padcev

enfortumab vedotin-ejfv

enfortumab

enfortumab vedotin-ejfv 20 MG Injection

enfortumab vedotin-ejfv 20 MG Injection [Padcev]

enfortumab vedotin-ejfv 30 MG Injection

enfortumab vedotin-ejfv 30 MG Injection [Padcev]

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