Uterine Cervical Neoplasms

<section class="Section" data-sectioncode="34089-3"><a name="ID_ea08e1dc-39b6-4541-a567-1f48ba199d81"></a><a name="section-9"></a><p></p><h1>11 DESCRIPTION</h1><p class="First">Tisotumab vedotin-tftv is a Tissue Factor (TF) directed antibody drug conjugate (ADC) comprised of a human anti-TF IgG1-kappa antibody conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable vc (valine-citrulline) linker. The monoclonal antibody is produced in a mammalian cell line (Chinese hamster ovary). MMAE and the linker are produced by chemical synthesis. Each monoclonal antibody molecule carries an average of 4 MMAE molecules. Tisotumab vedotin-tftv has an approximate molecular weight of 153 kDa. The chemical structure is as follows:<br/><br/>                                                                                      <span class="Bold">Figure 1. Structural Formula</span></p><div class="Figure"><img alt="Structural Formula" src="structure.jpg"/></div><p>TIVDAK (tisotumab vedotin-tftv) for injection, is provided as a sterile, preservative-free, white to off-white lyophilized cake or powder in a single-dose vial for infusion after dilution. Following reconstitution with 4 mL of Sterile Water for Injection, a clear to slightly opalescent, colorless to brownish-yellow solution containing 10 mg/mL tisotumab vedotin-tftv is produced <span class="Italics">[see Dosage and Administration (<a href="#ID_d8bda4c5-bb06-4d7c-997e-1c7987faed27">2.3</a>)]. </span>Each mL of reconstituted solution contains 10 mg of tisotumab vedotin-tftv, d-mannitol (30 mg), l-histidine (2.11 mg), l-histidine monohydrochloride (3.44 mg), and sucrose (30 mg), at pH 6.0.</p></section>

TIVDAK

tisotumab vedotin-tftv

tisotumab

tisotumab vedotin-tftv 40 MG Injection

Tivdak

tisotumab vedotin-tftv 40 MG Injection [Tivdak]

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