Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic product. N-acetyl-gamma-calicheamicin is covalently attached to the antibody via an acid-cleavable linker. Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-stranded DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.
This medicinal substance has been classified in the anatomical therapeutic chemical (ATC) classification according to its main therapeutic use as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01FB01 | Inotuzumab ozogamicin | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01F Monoclonal antibodies and antibody drug conjugates → L01FB CD22 (Clusters of Differentiation 22) inhibitors |
Competent medicine agencies globally have authorized commercialization of this active ingredient according to these medication package inserts (MPIs):
| Title | Information Source | Document Type | |
|---|---|---|---|
| BESPONSA Powder for concentrate for solution for infusion | European Medicines Agency (EU) | MPI, EU: SmPC |
Inotuzumab ozogamicin is an active ingredient of these brands:
United States (US)Australia (AU)Austria (AT)Brazil (BR)Canada (CA)Croatia (HR)Estonia (EE)Finland (FI)France (FR)Hong Kong (HK)Ireland (IE)Israel (IL)Japan (JP)Lithuania (LT)Netherlands (NL)New Zealand (NZ)Poland (PL)Romania (RO)Singapore (SG)Spain (ES)Turkey (TR)United Kingdom (UK)Note the following: The list of brand names is continuously updated, and thus does not include the total of products circulating worldwide. |
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