Lusutrombopag

(Mulpleta®)

Mulpleta®

Drug updated on 10/29/2024

Dosage FormTablet (oral; 3 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.

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Summary
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  • This summary is based on the review of four systematic review(s)/meta-analysis(es). [1-4]
  • Lusutrombopag significantly increased platelet counts in patients with chronic liver disease and severe thrombocytopenia compared to placebo, with an increase in patients achieving platelet counts of at least 50 x 10^9/L and an increase of at least 20 x 10^9/L (RR 6.39; 95% CI: 3.69, 11.07; p < 0.0001). Lusutrombopag also showed a favorable response compared to other treatments, though the advantage over avatrombopag was not statistically significant (OR 1.91; 95% CI 0.52, 7.05).
  • Lusutrombopag significantly reduced the need for platelet transfusions and rescue therapy for bleeding, with 68.0% of patients with HCC and 77.0% of non-HCC patients avoiding transfusions and achieving the primary endpoint compared to 8.9% and 21.6%, respectively, on placebo (P < .0001). Additionally, lusutrombopag reduced the risk of bleeding events (RR 0.55; 95% CI 0.32, 0.95; p = 0.03).
  • Lusutrombopag demonstrated a safety profile comparable to placebo, with similar thrombosis event rates between the two groups (RR 0.79; 95% CI 0.19, 3.24; p = 0.74), and did not increase the risk of bleeding or other serious adverse events compared to placebo in patients with chronic liver disease, including those with hepatocellular carcinoma (HCC).
  • No specific adverse events were highlighted in one of the reviewed studies, but inconsistencies in data reporting were noted, suggesting the need for more detailed safety assessments in future studies.
  • Lusutrombopag was evaluated in patients with chronic liver disease, including those with hepatocellular carcinoma (HCC). It was shown to be effective in increasing platelet counts, reducing the need for platelet transfusions, and lowering bleeding risks in both HCC and non-HCC populations. In patients with HCC, 68.0% achieved the primary endpoint compared to 8.9% on placebo, while in non-HCC patients, 77.0% reached the primary endpoint compared to 21.6% on placebo, with no significant differences in safety outcomes between the two groups.

Product Monograph / Prescribing Information

Document TitleYearSource
Mulpleta (lusutrombopag) Prescribing Information.2020Shionogi Inc., Florham Park, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines