Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 3 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.
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Summary
- Mulpleta (lusutrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease scheduled to undergo a procedure.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Primary Efficacy Outcomes: Lusutrombopag demonstrated a higher treatment response rate (RR 6.39; 95% CI 3.69, 11.07; p < 0.0001) and a greater proportion of patients avoiding platelet transfusion and rescue therapy for at least 7 days post-procedure compared to placebo (RR 3.42; 95% CI 1.86, 6.26; p = 0.0001).
- Secondary Effectiveness Outcomes: The risk of any bleeding event was significantly lower with lusutrombopag compared to placebo (RR 0.55; 95% CI 0.32, 0.95; p = 0.03).
- Effectiveness in Specific Populations: The efficacy data primarily pertains to patients with severe thrombocytopenia and chronic liver disease undergoing planned invasive procedures.
- Thrombosis Events: Thrombosis event rates were similar between lusutrombopag and placebo (RR 0.79; 95% CI 0.19, 3.24; p = 0.74).
- The reviewed studies provided no subgroup-specific information beyond the general population of patients with severe thrombocytopenia and chronic liver disease undergoing planned invasive procedures.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Mulpleta (lusutrombopag) Prescribing Information. | 2020 | Shionogi Inc., Florham Park, NJ |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
NCCN Guidelines® insights: Hematopoietic growth factors, Version 1.2022. | 2022 | Journal of the National Comprehensive Cancer Network |
Practice guidelines of the central european hepatologic collaboration (CEHC) on the use of thrombopoietin receptor agonists in patients with chronic liver disease undergoing invasive procedures. | 2021 | Journal of Clinical Medicine |
ACG clinical guideline: Disorders of the hepatic and mesenteric circulation. | 2020 | American Journal of Gastroenterology |
Lusutrombopag for treating thrombocytopenia in people with chronic liver disease needing a planned invasive procedure. | 2020 | National Institute for Health and Care Excellence |