Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Padcev 20 mg powder for concentrate for solution for infusion.
Padcev 30 mg powder for concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Powder for concentrate for solution for infusion. White to off-white lyophilized powder. |
Padcev 20 mg powder for concentrate for solution for infusion: One vial of powder for concentrate for solution for infusion contains 20 mg enfortumab vedotin.
Padcev 30 mg powder for concentrate for solution for infusion: One vial of powder for concentrate for solution for infusion contains 30 mg enfortumab vedotin.
After reconstitution, each mL of solution contains 10 mg of enfortumab vedotin.
Enfortumab vedotin is comprised of a fully human IgG1 kappa antibody, conjugated to the microtubule-disrupting agent monomethyl auristatin E (MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline linker.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Enfortumab vedotin |
Enfortumab vedotin is an antibody drug conjugate (ADC) targeting Nectin-4, an adhesion protein located on the surface of the urothelial cancer cells. It is comprised of a fully human IgG1-kappa antibody conjugated to the microtubule-disrupting agent MMAE via a protease-cleavable maleimidocaproyl valine-citrulline linker. Nonclinical data suggest that the anticancer activity of enfortumab vedotin is due to the binding of the ADC to Nectin-4-expressing cells, followed by internalisation of the ADC-Nectin-4 complex, and the release of MMAE via proteolytic cleavage. |
| List of Excipients |
|---|
|
Histidine |
Padcev 20 mg powder for concentrate for solution for infusion vial:
10 mL Type I glass vial with gray bromobutyl rubber stopper, 20 mm aluminum seal with a green ring and green cap. Each carton contains 1 vial.
Padcev 30 mg powder for concentrate for solution for infusion vial:
10 mL Type I glass vial with gray bromobutyl rubber stopper, 20 mm aluminum seal with a silver ring and yellow cap. Each carton contains 1 vial.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Date of first authorisation: 13 April 2022
| Drug | Countries | |
|---|---|---|
| PADCEV | Canada, Estonia, France, Croatia, Israel, Italy, Japan, Lithuania, Poland, United Kingdom, United States |
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