Gemtuzumab Ozogamicin (1 brand name, 1 dosage form, 1 route)
Available dosage forms: VIAL.
Routes of administration: SINGLE-DOSE.
Brand Names
- MYLOTARG
Boxed Warning
Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of MYLOTARG as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with MYLOTARG. (5.1 and 6.1)
Contraindications
MYLOTARG is contraindicated in patients with a history of hypersensitivity to the active substance in MYLOTARG or any of its components or to any of the excipients. Reactions have included anaphylaxis [see Warnings and Precautions (5.2), Adverse Reactions (6)].
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: •Hepatotoxicity, including VOD [see Warnings and Precautions (5.1)] •Infusion-related reactions [see Warnings and Precautions (5.2)] •Hemorrhage [see Warnings and Precautions (5.3)]
Mechanism of Action
Gemtuzumab ozogamicin is a CD33-directed antibody-drug conjugate (ADC). The antibody portion (hP67.6) recognizes human CD33 antigen. 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 gemtuzumab ozogamicin is due to the binding of the ADC to CD33-expressing tumor cells, followed by internalization of the ADC-CD33 complex, and the intracellular release of N-acetyl gamma calicheamicin dimethyl hydrazide via hydrolytic cleavage of the linker. Activation of N-acetyl gamma calicheamicin dimethyl hydrazide induces double-strand DNA breaks, subsequently inducing cell cycle arrest and apoptotic cell death.