Inotuzumab ozogamicin

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Information about Inotuzumab ozogamicin

Inotuzumab ozogamicin is a humanized monoclonal antibody-cytotoxin conjugate which is used in the therapy of refractory or relapsed acute lymphoblastic leukemia.

Liver safety of Inotuzumab ozogamicin

Inotuzumab ozogamicin has been linked to frequent serum enzyme elevations during therapy and with instances of clinically apparent acute liver injury, including acute sinusoidal obstruction syndrome which can be severe and even fatal.

Mechanism of action of Inotuzumab ozogamicin

Inotuzumab (in" oh tooz' ue mab) ozogamicin (oh" zoe ga mye' sin) is a humanized monoclonal antibody to the human CD24 cell surface marker which is highly expressed on malignant lymphoblastic leukemia cells. The monoclonal antibody is conjugated to a cytotoxic agent from a class of calicheamicins called ozogamicin. When inotuzumab binds to CD24, it is internalized and the ozogamicin is released by the action of lysosomal enzymes on the linker molecule that joins it to the monoclonal antibody. The released intracellular ozogamicin causes breaks in double stranded DNA that leads to apoptotic cell death.

FDA approval information for Inotuzumab ozogamicin

This monoclonal antibody conjugate has been shown to be effective in inducing remissions in refractory acute lymphoblastic leukemia and was given accelerated approval for this indication in the United States in 2017.

Brand name for Inotuzumab ozogamicin

Inotuzumab ozogamicin is available as 0.9 mg of lyophilized powder in single dose vials under the brand name Besponsa.

Dosage and administration for Inotuzumab ozogamicin

The recommended dose regimen varies by body weight, day of therapy and whether treating refractory vs relapsed acute lymphoblastic leukemia.

Side effects of Inotuzumab ozogamicin

Common side effects include bone marrow suppression, infections, fatigue, fever, nausea, headache, abdominal pain and hemorrhage. Less common but potentially serious side effects include severe myelosuppression, severe infections, clinically significant bleeding and hemorrhage, infusion related reactions, QTc interval prolongation and embryo-fetal toxicity.


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