Inotuzumab Ozogamicin (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: POWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER.
Brand Names
- BESPONSA
Indications and Usage
BESPONSA is indicated for the treatment of relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) in adult and pediatric patients 1 year and older.
Contraindications
None.
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label: •Hepatotoxicity, including hepatic VOD (also known as SOS) [see Warnings and Precautions (5.1)] •Increased risk of post-transplant non-relapse mortality [see Warnings and Precautions (5.2)] •Myelosuppression [see Warnings and Precautions (5.3)] •Infusion related reactions [see Warnings and Precautions (5.4)] •QT interval prolongation [see Warnings and Precautions (5.5)]
Mechanism of Action
Inotuzumab ozogamicin is a CD22-directed antibody drug conjugate (ADC). Inotuzumab recognizes human CD22. The small molecule, N-acetyl-gamma-calicheamicin, is a cytotoxic agent that is covalently attached to the antibody via a linker. Nonclinical data suggest that the anticancer activity of inotuzumab ozogamicin is due to the binding of the ADC to CD22-expressing tumor cells, followed by internalization of the ADC-CD22 complex, and the intracellular release of N-acetyl-gamma-calicheamicin dimethylhydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl-gamma-calicheamicin dimethylhydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.