Products
Inotuzumab ozogamicin was approved in many countries, in the EU, and in the United States in 2017 as a powder for a concentrate for the preparation of an infusion solution (Besponsa). See also under gemtuzumab ozogamicin.
Structure and properties
Inotuzumab ozogamicin is an antibody-drug conjugate directed against CD22. Inotuzumab is a humanized lgG4 monoclonal antibody that binds to CD22. Via an acid-cleavable linker, the antibody is linked to calicheamicin, which has cytotoxic properties.
Effects
Inotuzumab ozogamicin (ATC L01XC26) has cytotoxic properties. It binds to and is taken up by CD22-expressing tumor cells. Inside the cell, calicheamicin is released by hydrolytic cleavage of the linker. It causes double-strand breaks in DNA, which arrests the cell cycle and induces cell death by apoptosis. CD22 is a glycoprotein expressed on the surface of cancer cells.
Indications
For the treatment of CD22-positive relapsed or refractory B-precursor cell ALL (acute lymphoblastic leukemia).
Dosage
According to the SmPC. The drug is administered as an intravenous infusion.
Contraindications
Inotuzumab ozogamicin is contraindicated in cases of hypersensitivity. For complete precautions, see the drug label.
Adverse Effects
The most common possible adverse effects include:
- Thrombocytopenia, neutropenia, febrile neutropenia, anemia, leukopenia.
- Infections
- Exhaustion
- Bleeding
- Fever
- Nausea, abdominal pain, headache.
- Increased transaminases, increased gamma-glutamyltransferase, hyperbilirubinemia.