Difference between revisions of "Inotuzumab ozogamicin (Besponsa)"

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

Diffuse large B-cell lymphoma

Patient drug information

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

↑ ^1.0 ^1.1 ^1.2 Inotuzumab ozogamicin (Besponsa) package insert
↑ Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)
↑ Besponsa manufacturer's website
↑ NCT01363297 ClinicalTrials.Gov website]
↑ Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)

[insert-1] 1.0 ^1.1 ^1.2 Inotuzumab ozogamicin (Besponsa) package insert

[2] Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)

[3] Besponsa manufacturer's website

[4] NCT01363297 ClinicalTrials.Gov website]

[5] Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)

[1]

[2]

[3]

[4]

[5]

@@ Line 4: / Line 4: @@
 <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 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<ref name="insert"></ref>.
+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==