Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 20 mg) |
Drug Class | Thrombopoietin receptor agonists |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
- Indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
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Summary
- Doptelet (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure and for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment.
- This summary is based on the review of 13 systematic review(s)/meta-analysis(es). [1-13]
- Avatrombopag demonstrated a significantly higher platelet response compared to placebo (OR: 17.71, 95% CI: 11.01-28.48) and was more effective than eltrombopag and rhTPO in network meta-analyses (OR: 7.42; 95% CI: 1.74-31.69).
- Avatrombopag showed an increase in durable platelet response rates relative to placebo, and a reduction in the need for rescue therapy and the use of concomitant ITP medication.
- In patients with chronic liver disease, avatrombopag significantly increased preoperative platelet counts and reduced platelet transfusions compared to placebo.
- Compared to eltrombopag and romiplostim, avatrombopag had a lower incidence of any bleeding events (IRR 0.38 for both comparisons).
- Avatrombopag did not exhibit a significantly higher incidence of serious adverse events compared to placebo (RR: 1.18, 95% CI: 0.72-1.93), but general adverse events were slightly higher in avatrombopag-treated patients (RR: 1.25, 95% CI: 1.05-1.49).
- No significant increase in thrombotic events was observed with avatrombopag compared to placebo (OR=4.15, 95% CI: 0.20-85.23), and a meta-analysis suggested non-peptide TPO-RAs, including avatrombopag, were relatively safe concerning thrombotic events within 6 months (RR=1.92, 95% CI: 0.55-6.66).
- Subgroup analysis indicated that ITP patients with advanced age or a history of thrombosis had an increased thrombotic risk when receiving TAs therapy.
- There is no population type or subgroup information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Doptelet (avatrombopag) Prescribing Information. | 2021 | AkaRx, Inc., Durham, NC |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Australian public assessment report for doptelet. | 2024 | Australian Government Department of Health Therapeutic Goods Administration |
EHA guidelines on management of antithrombotic treatments in thrombocytopenic patients with cancer. | 2022 | Hemasphere |
Management of adult patients with immune thrombocytopenia (itp): a review on current guidance and experience from clinical practice. | 2021 | Journal of Blood Medicine |
Updated guidelines for immune thrombocytopenic purpura: expanded management options. | 2021 | Cleveland Clinic Journal of Medicine |
Practice guidelines of the Central European Hepatologic Ccollaboration (CEHC) on the use of thrombopoietin receptor agonists in patients with chronic liver disease undergoing invasive procedures. | 2021 | Journal of Clinical Medicine |
American Society of Hematology 2019 guidelines for immune thrombocytopenia. | 2019 | Blood Advances |