Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 100 mg, 150 mg) |
Drug Class | Kinase inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Latest News
Summary
- Tavalisse (fostamatinib disodium hexahydrate) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
- This summary is based on the review of three systematic reviews/meta-analyses. [1-3]
- Fostamatinib (Tavalisse): Demonstrated a stable response (SR) in 17.8% (18/101) of patients and an overall response (OR) in 42.5% (43/101) of patients. In comparison, the placebo group showed an SR of 2% (1/49) and an OR of 14% (7/49).
- Comparative Effectiveness: Rilzabrutinib had a higher SR (28% vs 17.8%) compared to fostamatinib. HMPL-523 showed superior SR (25% vs 17.8%) and OR (55% vs 42.5%) compared to fostamatinib.
- Avatrombopag, Eltrombopag, Romiplostim: These drugs were associated with significant improvements in durable platelet response and a reduced need for rescue therapy, with Romiplostim ranking highest in overall and early responses.
- Fostamatinib (Tavalisse) is associated with serious adverse events including dizziness (1%), hypertension (2%), diarrhea (1%), and neutropenia (1%), whereas Rilzabrutinib and HMPL-523 did not require dose reductions due to drug-related adverse effects.
- Avatrombopag significantly reduced the incidence of any bleeding events compared to placebo, eltrombopag, and romiplostim, with no statistically significant differences in adverse events compared to other drugs.
- The reviewed studies focused on adult patients (≥18 years old) with chronic immune thrombocytopenia (ITP) who have relapsed or refractory ITP with insufficient response to prior treatment; significant efficacy (OR, SR) and safety outcomes were observed across subgroups, particularly with fostamatinib, avatrombopag, eltrombopag, and romiplostim.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Tavalisse (fostamatinib disodium hexahydrate) Prescribing Information. | 2020 | Rigel Pharmaceuticals Inc., South San Francisco, CA |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
American Society of Hematology 2019 guidelines for immune thrombocytopenia. | 2019 | American Society of Hematology |