Inotuzumab ozogamicin (Besponsa)
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General information
Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. [1][2][3][4]
Route: IV
Extravasation: No information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information[1].
Diseases for which it is used
Diseases for which it was used
Patient drug information
- Inotuzumab ozogamicin (Besponsa) package insert[1]
- Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)[5]
History of changes in FDA indication
- 2017-08-17: FDA approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on INO-VATE ALL)
History of changes in EMA indication
- 2017-06-28: Initial authorization
Also known as
- Code name: CMC-544
- Brand name: Besponsa
References
- ↑ 1.0 1.1 1.2 Inotuzumab ozogamicin (Besponsa) package insert
- ↑ Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)
- ↑ Besponsa manufacturer's website
- ↑ [https://clinicaltrials.gov/ct2/show/NCT01363297 Clinical Trial Registry ClinicalTrials.Gov website]
- ↑ Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)