Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"
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Warner-admin (talk | contribs) m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information") |
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==General information== | ==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. <ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]</ref><ref>[[:File:Inotuzumabozogamicin.pdf | Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)]]</ref><ref>[https://www.besponsa.com/ Besponsa manufacturer's website]</ref><ref>[ | + | Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. <ref name="insert">[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]</ref><ref>[[:File:Inotuzumabozogamicin.pdf | Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)]]</ref><ref>[https://www.besponsa.com/ Besponsa manufacturer's website]</ref><ref>[https://clinicaltrials.gov/study/NCT01363297 NCT01363297] ClinicalTrials.Gov website]</ref> |
<br>Route: IV | <br>Route: IV | ||
<br>Extravasation: No information | <br>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 | + | 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 or the prescribing information<ref name="insert"></ref>. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 15: | Line 15: | ||
==Patient drug information== | ==Patient drug information== | ||
*[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]<ref name="insert"></ref> | *[http://labeling.pfizer.com/ShowLabeling.aspx?id=9503 Inotuzumab ozogamicin (Besponsa) package insert]<ref name="insert"></ref> | ||
| − | *[https://chemocare.com/ | + | *[https://chemocare.com/druginfo/inotuzumab-ozogamicin.aspx Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/inotuzumab-ozogamicin.aspx Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)]</ref> |
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2017-08-17: Approved for the treatment of adults with relapsed or refractory [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. ''(Based on INO-VATE ALL)'' |
| + | *2024-03-06: Approved for pediatric patients 1 year and older with relapsed or refractory CD22-positive [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2017-06-28: Initial authorization |
| + | ==History of changes in Health Canada indication== | ||
| + | *2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive [[B-cell acute lymphoblastic leukemia|B-cell precursor acute lymphoblastic leukemia (ALL)]]. | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia]]. | ||
| + | |||
==Also known as== | ==Also known as== | ||
*'''Code name:''' CMC-544 | *'''Code name:''' CMC-544 | ||
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[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| + | [[Category:Protein expression-specific medications]] | ||
| − | + | [[Category:Anti-CD22 antibody-drug conjugates]] | |
| − | [[Category: | ||
| − | |||
[[Category:Enediyne antibiotic]] | [[Category:Enediyne antibiotic]] | ||
| Line 43: | Line 49: | ||
[[Category:EMA approved in 2017]] | [[Category:EMA approved in 2017]] | ||
[[Category:FDA approved in 2017]] | [[Category:FDA approved in 2017]] | ||
| + | [[Category:Health Canada approved in 2018]] | ||
| + | [[Category:PMDA approved in 2018]] | ||
[[Category:Pfizer product]] | [[Category:Pfizer product]] | ||
Latest revision as of 00:59, 29 June 2024
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 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: Approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on INO-VATE ALL)
- 2024-03-06: Approved for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
History of changes in EMA indication
- 2017-06-28: Initial authorization
History of changes in Health Canada indication
- 2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
History of changes in PMDA indication
- 2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive acute lymphoblastic leukemia.
Also known as
- Code name: CMC-544
- Brand name: Besponsa
References
Categories:
- Drugs
- Intravenous medications
- Protein expression-specific medications
- Anti-CD22 antibody-drug conjugates
- Enediyne antibiotic
- B-cell acute lymphoblastic leukemia medications
- Follicular lymphoma medications
- Diffuse large B-cell lymphoma medications (historic)
- EMA approved in 2017
- FDA approved in 2017
- Health Canada approved in 2018
- PMDA approved in 2018
- Pfizer product