Drug updated on 5/17/2024
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
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Summary
- Fostamatinib disodium hexahydrate (Tavalisse) is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments.
- Three studies provided insights into Tavalisse's safety and effectiveness compared to other drugs such as HMPL-523, rilzabrutinib, avatrombopag, eltrombopag, and romiplostim.
- In clinical trials involving 255 adult patients with relapsed/refractory ITP, where 101 were treated with fostamatinib, the overall response rate was 42.5%, the stable response rate was 17.8%, while serious adverse events occurred at low rates of 1%-2% including dizziness, hypertension, diarrhea, and neutropenia.
- A network meta-analysis found that fostamatinib showed statistically significant improvements versus placebo in durable platelet response and incidence of any bleeding events, but no between-treatment differences were observed against eltrombopag or romiplostim specifically regarding bleeding incidents.
- Another study aimed to rank the efficacy and safety of ITP medications suggested romiplostim as most suitable followed by avatrombopag, then eltrombopag before fostamatinib, which indicates its comparable safety profile among second-line treatments despite a lower efficacy ranking.
- The focus on adults suffering from chronic ITP who haven't responded adequately to prior treatments underlines this drug's target patient population, indicating it may be considered for cases of relapsed or refractory ITP due to its challenging nature when treating this subgroup.
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 |