Difference between revisions of "Fostamatinib (Tavalisse)"

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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==
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Class/mechanism: Spleen tyrosine kinase (SYK) inhibitor. The main metabolite of fostamatinib is R406, which reduces antibody-mediated destruction of platelets. R406 also inhibits signal transduction of Fc-activating receptors and B-cell receptor.<ref name=insert>[http://tavalisse.com/downloads/pdf/Full-Prescribing-Information.pdf Fostamatinib (Tavalisse) package insert]</ref><ref>[[Media:Fostamatinib.pdf | Fostamatinib (Tavalisse) package insert (locally hosted backup)]]</ref><ref>[http://tavalisse.com/ Tavalisse manufacturer's website]</ref>
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Class/mechanism: Spleen tyrosine kinase (SYK) inhibitor. The main metabolite of fostamatinib is R406, which reduces antibody-mediated destruction of platelets. R406 also inhibits signal transduction of Fc-activating receptors and B-cell receptor.<ref name=insert>[http://tavalisse.com/downloads/pdf/Full-Prescribing-Information.pdf Fostamatinib (Tavalisse) package insert]</ref><ref>[[:File:Fostamatinib.pdf | Fostamatinib (Tavalisse) package insert (locally hosted backup)]]</ref><ref>[http://tavalisse.com/ Tavalisse manufacturer's website]</ref><ref>Podolanczuk A, Lazarus AH, Crow AR, Grossbard E, Bussel JB. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk. Blood. 2009 Apr 2;113(14):3154-60. [https://doi.org/10.1182/blood-2008-07-166439 link to original article] [https://pubmed.ncbi.nlm.nih.gov/19096013/ PubMed]</ref><ref>Newland A, Lee EJ, McDonald V, Bussel JB. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018 Jan;10(1):9-25. [https://www.futuremedicine.com/doi/10.2217/imt-2017-0097?url_ver=Z39.88-2003 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28967793/ PubMed]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
  
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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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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==
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*[[Autoimmune thrombocytopenic purpura (ITP)]]
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*[[Immune thrombocytopenia (ITP)]]
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*[[Diffuse large B-cell lymphoma]]
 
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*[[Follicular lymphoma]]
 
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==Preliminary data==
 
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===[[Diffuse large B-cell lymphoma]]; [[Follicular lymphoma]]===
 
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# Friedberg JW, Sharman J, Sweetenham J, Johnston PB, Vose JM, Lacasce A, Schaefer-Cutillo J, De Vos S, Sinha R, Leonard JP, Cripe LD, Gregory SA, Sterba MP, Lowe AM, Levy R, Shipp MA. Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood. 2010 Apr 1;115(13):2578-85. Epub 2009 Nov 17. [http://www.bloodjournal.org/content/115/13/2578.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/19965662 PubMed]
 
  
 
==Patient drug information==
 
==Patient drug information==
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==History of changes in FDA indication==
 
==History of changes in FDA indication==
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*4/17/2018: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604956.htm Granted FDA regular approval] "for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment."
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*2018-04-17: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604956.htm Granted FDA regular approval] "for the treatment of thrombocytopenia in adult patients with chronic [[Immune_thrombocytopenia|immune thrombocytopenia (ITP)]] who have had an insufficient response to a previous treatment."
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==History of changes in EMA indication==
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*2020-01-09: Initial authorization as Tavlesse
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==History of changes in Health Canada indication==
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*2020-11-19: Initial notice of compliance
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==History of changes in PMDA indication==
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*2022-12-23: Initial approval
 
==Also known as==
 
==Also known as==
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*'''Code names:''' R788, R935788
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*'''Code names:''' R-788, R-935788
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*'''Brand name:''' Tavalisse, Tavlesse
  
 
==References==
 
==References==
 
<references/>
 
<references/>
  
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[[Category:Drug index]]
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[[Category:Drugs]]
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[[Category:Chemotherapy]]
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[[Category:Oral medications]]
 
[[Category:Hematology medications]]
 
[[Category:Hematology medications]]
  
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[[Category:Immune thrombocytopenic purpura (ITP) medications]]
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[[Category:Immune thrombocytopenia medications]]
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[[Category:Kinase inhibitors]]
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[[Category:SYK inhibitors]]
 
[[Category:SYK inhibitors]]
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[[Category:Drugs FDA approved in 2018]]
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[[Category:FDA approved in 2018]]
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[[Category:EMA approved in 2020]]
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[[Category:Health Canada approved in 2020]]
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[[Category:PMDA approved in 2022]]

Latest revision as of 01:02, 29 June 2024

General information

Class/mechanism: Spleen tyrosine kinase (SYK) inhibitor. The main metabolite of fostamatinib is R406, which reduces antibody-mediated destruction of platelets. R406 also inhibits signal transduction of Fc-activating receptors and B-cell receptor.[1][2][3][4][5]
Route: PO
Extravasation: n/a

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

Patient drug information

History of changes in FDA indication

History of changes in EMA indication

  • 2020-01-09: Initial authorization as Tavlesse

History of changes in Health Canada indication

  • 2020-11-19: Initial notice of compliance

History of changes in PMDA indication

  • 2022-12-23: Initial approval

Also known as

  • Code names: R-788, R-935788
  • Brand name: Tavalisse, Tavlesse

References

  1. ↑ 1.0 1.1 1.2 Fostamatinib (Tavalisse) package insert
  2. ↑ Fostamatinib (Tavalisse) package insert (locally hosted backup)
  3. ↑ Tavalisse manufacturer's website
  4. ↑ Podolanczuk A, Lazarus AH, Crow AR, Grossbard E, Bussel JB. Of mice and men: an open-label pilot study for treatment of immune thrombocytopenic purpura by an inhibitor of Syk. Blood. 2009 Apr 2;113(14):3154-60. link to original article PubMed
  5. ↑ Newland A, Lee EJ, McDonald V, Bussel JB. Fostamatinib for persistent/chronic adult immune thrombocytopenia. Immunotherapy. 2018 Jan;10(1):9-25. link to original article PubMed
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