Precautions of Lusutrombopag

Thrombosis/Thromboembolic Complications

Lusutrombopag is a thrombopoietin receptor agonist, and thrombopoietin receptor agonists are associated with thrombosis and thromboembolic complications in patients with chronic liver disease. There have been reports of portal vein thrombosis in patients with chronic liver disease treated with TPO receptor agonists. In three randomized, double-blind trials, portal vein thrombosis was reported in 1% of patients in the lusutrombopag treatment group (2 out of 171 cases) and 1% of patients in the placebo group (2 out of 170 cases); these thromboses were detected postoperatively during protocol-specified imaging examinations. Thrombosis was not associated with a significant increase in platelet count.

When using lusutrombopag in patients with known risk factors for thromboembolism (including hereditary thrombophilia such as factor V Leiden, prothrombin 20210A, antithrombin deficiency, or protein C or S deficiency), the potential increased risk of thrombosis should be considered. For patients with a current or past history of thrombosis or absence of hepatic blood inflow, lusutrombopag should be used only when the potential benefits to the patient outweigh the potential risks.

Lusutrombopag should not be used in patients with chronic liver disease for the purpose of normalizing platelet counts.

FDA，2018.07