Difference between revisions of "Ibritumomab tiuxetan (Zevalin)"

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==General information==
 
==General information==
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Class/mechanism: Zevalin is a CD20-directed radiotherapeutic antibody administered as part of
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Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).<ref name="insert">[https://zevalin.com/wp-content/uploads/2019/04/PI-ZEVALIN-092019.pdf Ibritumomab tiuxetan (Zevalin) package insert]</ref><ref>[[:File:Ibritumomab.pdf | Ibritumomab tiuxetan (Zevalin) package insert (locally hosted backup)]]</ref><ref>[http://www.zevalin.com/ Zevalin manufacturer's website]</ref>
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the Zevalin therapeutic regimen indicated for the treatment of patients with:
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<br>Route: IV
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<br>Extravasation: potential [[vesicant]]
  
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Ibritumomab tiuxetan binds specifically to the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35). The apparent affinity (KD) of ibritumomab tiuxetan for the CD20 antigen ranges between approximately 14 to 18 nM. The CD20 antigen is expressed on pre-B and mature B lymphocytes and on > 90% of B-cell non-Hodgkin’s lymphomas (NHL). The CD20 antigen is not shed from the cell surface and does not internalize upon antibody binding. The chelate tiuxetan, which tightly binds In-111 or Y-90, is covalently linked to ibritumomab. The beta emission from Y- 90 induces cellular damage by the formation of free radicals in the target and neighboring cells. Ibritumomab tiuxetan binding was observed in vitro on lymphoid cells of the bone marrow, lymph node, thymus, red and white pulp of the spleen, and lymphoid follicles of the tonsil, as well as lymphoid nodules of other organs such as the large and small intestines.
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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], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
  
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<ref name="insert">[http://www.zevalin.com/v3/pdf/Zevalin_PI_Website.pdf Ibritumomab (Zevalin) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/ibritumomab.pdf Ibritumomab (Zevalin) package insert (locally hosted backup)]</ref>
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==Diseases for which it is established ''(work in progress)''==
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<br>Route: TBD
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*[[Follicular lymphoma]]
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<br>Extravasation: TBD
 
  
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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], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the package insert<ref name="insert"></ref>.
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==Diseases for which it is used==
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*[[Diffuse large B-cell lymphoma]]
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*[[Mantle cell lymphoma]]
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*[[Marginal zone lymphoma]]
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/bio/ibritumomab.asp Ibritumomab (Zevalin) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/ibritumomab.asp Ibritumomab (Zevalin) patient drug information (Chemocare)]</ref>
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*[https://zevalin.com/wp-content/uploads/2019/04/PI-ZEVALIN-092019.pdf Ibritumomab tiuxetan (Zevalin) package insert]<ref name="insert"></ref>
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*[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab (Zevalin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab (Zevalin) patient drug information (UpToDate)]</ref>
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*[https://chemocare.com/druginfo/ibritumomab.aspx Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/ibritumomab.aspx Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)]</ref>
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*[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/ibritumomab-patient-drug-information Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication==
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*2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory [[:Category:Indolent lymphomas|low-grade]], [[Follicular lymphoma |follicular]], or [[Transformed lymphoma|transformed]] B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. ''(Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)''
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**2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated [[Follicular lymphoma | follicular NHL]] in patients who achieve a partial or complete response to first-line chemotherapy. ''(Based on FIT)''
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==History of changes in EMA indication==
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*2004-01-16: Initial authorization
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*Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with [[follicular lymphoma]]. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
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*Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ [[Follicular lymphoma|follicular B-cell non-Hodgkin's lymphoma (NHL)]].
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==History of changes in PMDA indication==
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*2008-01-25: Initial approval for the treatment of relapsed or refractory, CD20-positive lymphomas of the following: [[:Category:Indolent lymphomas|low-grade B-cell non-Hodgkin’s lymphoma]] and [[mantle cell lymphoma]].
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==Also known as==
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*'''Brand name:''' Zevalin
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Intravenous medications]]
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[[Category:Anti-CD20 radioimmunoconjugates]]
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[[Category:Radiotherapy medications]]
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[[Category:Diffuse large B-cell lymphoma medications]]
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[[Category:Follicular lymphoma medications]]
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[[Category:Mantle cell lymphoma medications]]
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[[Category:Marginal zone lymphoma medications]]
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[[Category:FDA approved in 2002]]
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[[Category:EMA approved in 2004]]
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[[Category:PMDA approved in 2008]]

Latest revision as of 23:32, 2 September 2023

General information

Class/mechanism: Anti-CD20 antibody chelated by tiuxetan to a radioactive agent (Y-90, yttrium-90; or In-111, indium-111). Y-90 emits beta radiation, which causes cellular damage via free radicals. This results in damage to cells which express the CD20 antigen (human B-lymphocyte-restricted differentiation antigen, Bp35).[1][2][3]
Route: IV
Extravasation: potential vesicant

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 established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2002-02-19: Granted FDA accelerated approval for the treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin’s lymphoma. (Based on Wiseman et al. 2002, Witzig et al. 2002a, Witzig et al. 2002b)
    • 2009-09-03: Granted FDA full approval; label expanded for the treatment of previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy. (Based on FIT)

History of changes in EMA indication

  • 2004-01-16: Initial authorization
  • Uncertain date: [90Y]-radiolabelled Zevalin is indicated in adults as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established.
  • Uncertain date: [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsed or refractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).

History of changes in PMDA indication

Also known as

  • Brand name: Zevalin

References

  1. ↑ 1.0 1.1 1.2 Ibritumomab tiuxetan (Zevalin) package insert
  2. ↑ Ibritumomab tiuxetan (Zevalin) package insert (locally hosted backup)
  3. ↑ Zevalin manufacturer's website
  4. ↑ Ibritumomab tiuxetan (Zevalin) patient drug information (Chemocare)
  5. ↑ Ibritumomab tiuxetan (Zevalin) patient drug information (UpToDate)
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