Drug updated on 3/28/2024
| 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.
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 a previous treatment.
- Three systematic reviews/meta-analyses were reviewed, providing insights into the safety and efficacy of Tavalisse compared to other treatments for ITP.
- In one study involving 255 adult patients with relapsed/refractory ITP, fostamatinib was administered to 101 participants; it achieved a stable response in 17.8% and overall response in 42.5% of these patients, outperforming placebo groups significantly.
- Another review found that targeted therapies like Tavalisse increased platelet counts and decreased bleeding events without increasing toxicity when compared to placebos; this suggests its potential as a second-line treatment option for adults suffering from ITP.
- A network meta-analysis ranked romiplostim as the most suitable treatment based on overall responses among previously treated adults with ITP but noted that fostamatinib also showed promising results alongside avatrombopag and eltrombopag alternatives.
- Adverse effects associated with Tavalisse included dizziness, hypertension, diarrhea, and neutropenia according to one clinical trial report; however no dose reduction due to drug-related adverse effects was required by any patient taking rilzabrutinib or HMPL-523 during trials mentioned across studies reviewed.
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 |