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Precautions of Avatrombopag

1.Thrombotic/Thromboembolic Complications

Avatrombopag is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic immune thrombocytopenia. In patients with chronic liver disease, thromboembolic events (portal vein thrombosis) occurred in 0.4% (1/274) of patients receiving Avatrombopag. In patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% (9/128) of patients receiving Avatrombopag.

Consider the potential increased thrombotic risk when administering Avatrombopag to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (e.g., Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

Avatrombopag should not be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts. Monitor platelet counts and follow the dosing guidelines to achieve target platelet counts. Monitor patients receiving Avatrombopag for signs and symptoms of thromboembolic events and institute treatment promptly. 

from FDA，2021.06