Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Tivdak 40 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
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Powder for concentrate for solution for infusion. White to off-white lyophilised cake or powder. |
One vial of powder for concentrate for solution for infusion contains 40 mg tisotumab vedotin.
After reconstitution, each mL of solution for infusion contains 10 mg of tisotumab vedotin.
Tisotumab vedotin is comprised of a fully human IgG1-kappa antibody conjugated to the monomethyl auristatin E (MMAE) via a protease-cleavable vc (valine citrulline) linker.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Tisotumab vedotin is an antibody-drug conjugate (ADC) directed to tissue factor (TF), a cell surface protein expressed at elevated levels on a variety of solid tumours relative to normal tissue. The small molecule, MMAE, is a microtubule-disrupting agent, attached to the antibody via a protease-cleavable linker. Tisotumab vedotin binds to TF-expressing tumour cells, the ADC-TF complex is internalised, and local release of MMAE occurs via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. |
| List of Excipients |
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L-histidine |
10 mL Type I glass vial with grey butyl rubber stopper, plug and top, 20 mm seal with silver coloured aluminium cap and garnet disc. Each carton contains 1 vial.
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
EU/1/25/1911/001
| Drug | Countries | |
|---|---|---|
| TIVDAK | United States |
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