Fostamatinib (Tavalisse)

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.
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.

Diseases for which it is used

• Immune thrombocytopenia (ITP)

Patient drug information

• Fostamatinib (Tavalisse) package insert

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