Rigel announced the launch of Tavalisse (fostamatinib disodium hexahydrate) tablets for the the treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had insufficient response to previous treatment.
Tavalisse, an oral spleen tyrosine kinase (SYK) inhibitor, was initially approved by the Food and Drug Administration (FDA) in April 2018. The approval was based on Phase 3 data from Study FIT-1, FIT-2, and FIT-3 as well as an initial proof of concept study. Tavalisse targets the underlying autoimmune cause through its major metabolite, R406, that inhibits signal transduction of Fc-activating receptors and B-cell receptor and ultimately reduces antibody-mediated destruction of platelets.
Treatment with Tavalisse should be discontinued after 12 weeks if the platelet count does not increase to a level sufficient to avoid clinically important bleeding. The most common adverse reactions include diarrhea, hypertension, nausea, respiratory infection, dizziness, ALT/AST increase, rash, abdominal pain, fatigue, chest pain, and neutropenia. Management of some adverse reactions (i.e., hypertension, hepatotoxicity, diarrhea, neutropenia) may require dose-interruption, reduction, or discontinuation.
Tavalisse is available as 100mg and 150mg strength tablets in 60-count bottles. The Company has also introduced a support center (Rigel ONECARE) to help patients and clinicians navigate through insurance coverage requirements and provide financial assistance when needed.
For more information call (800) 983-1329 or visit Tavalisse.com.