Difference between revisions of "Fostamatinib (Tavalisse)"
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
*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|immune thrombocytopenia (ITP)]] who have had an insufficient response to a previous treatment." | *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|immune thrombocytopenia (ITP)]] who have had an insufficient response to a previous treatment." | ||
| − | + | ==History of changes in EMA indication== | |
| + | *1/9/2020: Initial authorization | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' R788, R935788 | *'''Code names:''' R788, R935788 | ||
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[[Category:SYK inhibitors]] | [[Category:SYK inhibitors]] | ||
[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2020]] | ||
Revision as of 00:19, 1 January 2023
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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 4/17/2018: 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."
History of changes in EMA indication
- 1/9/2020: Initial authorization
Also known as
- Code names: R788, R935788
- Brand name: Tavalisse
References
- ↑ 1.0 1.1 1.2 Fostamatinib (Tavalisse) package insert
- ↑ Fostamatinib (Tavalisse) package insert (locally hosted backup)
- ↑ Tavalisse manufacturer's website
- ↑ 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
- ↑ 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