Difference between revisions of "Fostamatinib (Tavalisse)"
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| − | = | + | ==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.<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>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.<ref name="insert"></ref> |
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Immune thrombocytopenia (ITP)]] | |
| − | [[Category: | + | ==Patient drug information== |
| − | [[Category: | + | *[http://tavalisse.com/downloads/pdf/Full-Prescribing-Information.pdf Fostamatinib (Tavalisse) package insert]<ref name="insert"></ref> |
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *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." | ||
| + | ==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== | ||
| + | <references/> | ||
| + | |||
| + | [[Category:Drugs]] | ||
| + | [[Category:Oral medications]] | ||
| + | [[Category:Hematology medications]] | ||
| + | |||
| + | [[Category:Immune thrombocytopenia medications]] | ||
| − | |||
[[Category:SYK inhibitors]] | [[Category:SYK inhibitors]] | ||
| − | + | [[Category:FDA approved in 2018]] | |
| − | [[Category: | + | [[Category:EMA approved in 2020]] |
| + | [[Category:Health Canada approved in 2020]] | ||
| + | [[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
- 2018-04-17: 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
- 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
- ↑ 1.0 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