Avatrombopag

(Doptelet®)

Doptelet®

Drug updated on 9/4/2024

Dosage FormTablet (oral; 20 mg)
Drug ClassThrombopoietin 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
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  • 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 TitleYearSource
Doptelet (avatrombopag) Prescribing Information.2021AkaRx, Inc., Durham, NC

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Thrombopoietin receptor agonists use and risk of thrombotic events in patients with immune thrombocytopenic purpura: a systematic review and meta analysis of randomized controlled trials.2024Biomedical Reports
Efficacy and safety of thrombopoietin receptor agonists in children and adults with persistent and chronic immune thrombocytopenia: a meta-analysis.2023Expert Opinion on Pharmacotherapy
Safety of non-peptide thrombopoietin receptor agonists in patients with immune thrombocytopenia: a systematic review and meta analysis of short term double blind randomized clinical trials. 2023Experimental and Therapeutic Medicine
Risk of thrombotic events in immune thrombocytopenia patients treated with thrombopoietic agents: a systematic review and meta-analysis. 2023Thrombosis Journal
Use of thrombopoietin receptor agonists in adults with immune thrombocytopenia: a systematic review and Central European expert consensus. 2023Annals of Hematology
Efficacy and incidence of treatment-related adverse events of thrombopoietin receptor agonists in adults with immune thrombocytopenia: a systematic review and network meta-analysis of randomized controlled study.2023Acta Haematologica
Comparative efficacy of 19 drug therapies for patients with idiopathic thrombocytopenic purpura: a multiple-treatments network meta-analysis. 2022Annals of Hematology
Thrombopoietin receptor agonists for the treatment of primary immune thrombocytopenia: a meta-analysis and systematic review.2021Platelets
Efficacy and safety of avatrombopag in patients with chronic immune thrombocytopenia: a systematic literature review and network meta-analysis.2021Advances in Therapy
The efficacy and safety of thrombopoietin receptor agonists in patients with chronic liver disease undergoing elective procedures: a systematic review and meta-analysis.2021Platelets
Comparative efficacy and safety of thrombopoietin receptor agonists in adults with thrombocytopenia: a systematic review and network meta-analysis of randomized controlled trial.2021Frontiers in Pharmacology
Therapeutic options for adult patients with previously treated immune thrombocytopenia – a systematic review and network meta-analysis.2019Hematology
Efficacy and safety of avatrombopag in patients with thrombocytopenia: a systematic review and meta-analysis of randomized controlled trials.2019Frontiers in Pharmacology

Clinical Practice Guidelines