PADCEV

This brand name is authorized in Canada, Estonia, Israel, Japan, Lithuania, Poland, United Kingdom, United States

Active ingredients

The drug PADCEV contains one active pharmaceutical ingredient (API):

1 Enfortumab vedotin
UNII DLE8519RWM - 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.

Read about Enfortumab vedotin

Medication package inserts

Below package inserts are available for further reading:

Title Information Source Document Type  
PADCEV EJFV Powder for solution for injection FDA, National Drug Code (US) MPI, US: SPL/PLR
PADCEV Powder for solution for infusion European Medicines Agency (EU) MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code Group title Classification
L01FX13 Enfortumab vedotin L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FX Other monoclonal antibodies
Discover more medicines within L01FX13

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country Identification scheme Identifier(s)
Country: CA Health Products and Food Branch Identifier(s): 02521903, 02521911
Country: EE Ravimiamet Identifier(s): 1880748, 1880759
Country: IL מִשְׂרַד הַבְּרִיאוּת Identifier(s): 8782, 8783
Country: JP 医薬品医療機器総合機構 Identifier(s): 4291459D1020, 42914E0D2026
Country: LT Valstybinė vaistų kontrolės tarnyba Identifier(s): 1094618, 1094619
Country: PL Rejestru Produktów Leczniczych Identifier(s): 100469050, 100469068
Country: US FDA, National Drug Code Identifier(s): 51144-020, 51144-030

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