Difference between revisions of "Tositumomab and I-131 (Bexxar)"

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'''Note: GlaxoSmithKline has discontinued the manufacture and sale of the BEXXAR therapeutic regimen (tositumomab and iodine I 131 tositumomab) as of February 2014.'''
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==General information==
 
==General information==
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Class/mechanism: <ref name="insert">[http://us.gsk.com/products/assets/us_bexxar.pdf Tositumomab & I-131 (Bexxar) package insert]</ref><ref>[http://hemonc.org/docs/packageinsert/tositumomabI131.pdf Tositumomab & I-131 (Bexxar) package insert (locally hosted backup)]</ref>
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Class/mechanism: Radioimmunotherapy; treatment regimen that includes two separate steps: first, a dosimetric dose with an anti-CD20 antibody (tositumomab) alone, and second, a therapeutic dose with tositumomab bound to a radioactive isotope, iodone-131 (I-131).  Tositumomab binds to the extracellular domain of the CD20 molecule expressed on B-cells and may induce complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC).  The I-131 that is bound to tositumomab emits ionizing radiation, leading to cell death.<ref name="insert">[http://us.gsk.com/products/assets/us_bexxar.pdf Tositumomab and I-131 (Bexxar) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/tositumomabI131.pdf Tositumomab and I-131 (Bexxar) package insert (locally hosted backup)]</ref>
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<br>Route: TBD
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<br>Route: IV
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<br>Extravasation: TBD
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<br>Extravasation: no information
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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 Micromedex, 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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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 was used==
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*[[Transformed lymphoma]]
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*[[Follicular lymphoma]]
  
 
==Patient drug information==
 
==Patient drug information==
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*[http://chemocare.com/bio/tositumomab.asp Tositumomab & I-131 (Bexxar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/tositumomab.asp Tositumomab & I-131 (Bexxar) patient drug information (Chemocare)]</ref>
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*[http://chemocare.com/bio/tositumomab.asp Tositumomab and I-131 (Bexxar) patient drug information (Chemocare)]<ref>[http://chemocare.com/bio/tositumomab.asp Tositumomab and I-131 (Bexxar) patient drug information (Chemocare)]</ref>
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*[http://www.uptodate.com/contents/tositumomabI131-patient-drug-information Tositumomab & I-131 (Bexxar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/tositumomabI131-patient-drug-information Tositumomab & I-131 (Bexxar) patient drug information (UpToDate)]</ref>
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*[http://www.uptodate.com/contents/tositumomab-radioconjugate-patient-drug-information Tositumomab and I-131 (Bexxar) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/tositumomab-radioconjugate-patient-drug-information Tositumomab and I-131 (Bexxar) patient drug information (UpToDate)]</ref>
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==History of changes in FDA indication - '''PARTIALLY WITHDRAWN'''==
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*2003-06-27: Granted accelerated approval for the treatment of patients with [[Biomarkers#CD20|CD20]] [[Biomarkers#Expression|positive]], [[Follicular lymphoma|follicular, non-Hodgkin's lymphoma]], with and without transformation, whose disease is refractory to [[Rituximab (Rituxan)]] and has relapsed following chemotherapy. ''(Based on CP-97-012 & RIT-II-004)''
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*2004-12-22: Accelerated approval for patients with relapsed or refractory, [[:Category:Indolent_lymphomas|low grade]], [[Follicular lymphoma|follicular]] or [[Transformed lymphoma|transformed]] [[Biomarkers#CD20|CD20]] [[Biomarkers#Expression|positive]] non-Hodgkin's lymphoma who have not received [[Rituximab (Rituxan)]]. ''(No supporting studies are cited)''
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**2013-10-23: Accelerated approval for rituximab-naive patients withdrawn. ''(failure to complete confirmatory study)''
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==Also known as==
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*'''Generic names:''' tositumomab and I 131 tositumomab, tositumomab and iodine-131 tositumomab
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*'''Brand name:''' Bexxar
  
 
==References==
 
==References==
 
<references/>
 
<references/>
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[[Category:Drugs]]
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[[Category:Intravenous medications]]
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[[Category:Protein expression-specific medications]]
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[[Category:Anti-CD20 radioimmunoconjugates]]
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[[Category:Radiotherapy medications]]
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[[Category:Follicular lymphoma medications (historic)]]
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[[Category:Transformed lymphoma medications (historic)]]
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[[Category:FDA approved in 2003]]
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[[Category:FDA withdrawn in 2013]]

Latest revision as of 12:01, 29 June 2024

Note: GlaxoSmithKline has discontinued the manufacture and sale of the BEXXAR therapeutic regimen (tositumomab and iodine I 131 tositumomab) as of February 2014.

General information

Class/mechanism: Radioimmunotherapy; treatment regimen that includes two separate steps: first, a dosimetric dose with an anti-CD20 antibody (tositumomab) alone, and second, a therapeutic dose with tositumomab bound to a radioactive isotope, iodone-131 (I-131). Tositumomab binds to the extracellular domain of the CD20 molecule expressed on B-cells and may induce complement-dependent cytotoxicity (CDC) and/or antibody-dependent cell mediated cytotoxicity (ADCC). The I-131 that is bound to tositumomab emits ionizing radiation, leading to cell death.[1][2]
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 was used

Patient drug information

History of changes in FDA indication - PARTIALLY WITHDRAWN

Also known as

  • Generic names: tositumomab and I 131 tositumomab, tositumomab and iodine-131 tositumomab
  • Brand name: Bexxar

References

  1. ↑ 1.0 1.1 Tositumomab and I-131 (Bexxar) package insert
  2. ↑ Tositumomab and I-131 (Bexxar) package insert (locally hosted backup)
  3. ↑ Tositumomab and I-131 (Bexxar) patient drug information (Chemocare)
  4. ↑ Tositumomab and I-131 (Bexxar) patient drug information (UpToDate)
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