DOPTELET

What it is

DOPTELET contains avatrombopag maleate . Each tablet contains 23.6 mg avatrombopag maleate (equivalent to 20 mg of avatrombopag) . Avatrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets .

Approved indications

— Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure . — Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment .

Dosing overview

Dosing differs by indication. For chronic liver disease, DOPTELET should be taken orally once daily for 5 consecutive days with food, beginning 10 to 13 days prior to the scheduled procedure . The recommended dose is based on platelet count prior to the scheduled procedure: 60 mg once daily for 5 days if platelet count is less than 40 × 10⁹/L, or 40 mg once daily for 5 days if platelet count is 40 to less than 50 × 10⁹/L . For chronic immune thrombocytopenia, the lowest dose of DOPTELET needed to achieve and maintain a platelet count greater than or equal to 50 × 10⁹/L should be used, beginning at a starting dose of 20 mg once daily with food . Dose adjustments are based on platelet count response, with a maximum daily dose of 40 mg .

Key safety warnings

DOPTELET 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% of patients receiving DOPTELET, whilst in patients with chronic immune thrombocytopenia, thromboembolic events (arterial or venous) occurred in 7% of patients receiving DOPTELET . Monitor patients receiving DOPTELET for signs and symptoms of thromboembolic events and institute treatment promptly . Thrombocytopenia is likely to reoccur in ITP patients upon discontinuation of treatment with avatrombopag, with platelet counts returning to baseline levels within 2 weeks in the majority of patients, which increases the bleeding risk and in some cases may lead to bleeding . Patients should be closely monitored for a decrease in platelet count and medically managed to avoid bleeding upon discontinuation of treatment with avatrombopag . This medicinal product is subject to additional monitoring in Australia to allow quick identification of new safety information .

Contraindications

Known hypersensitivity to avatrombopag or to any of the inactive ingredients .

PBS listing

The 20 mg tablet is listed on the PBS as 2 items with authority required restriction at an ex-manufacturer price of A$2601.06 .

Regulatory history

DOPTELET was first approved on 16 January 2023 . ARTG registration 375471 for DOPTELET avatrombopag 20 mg film-coated tablets was first listed on 2023-01-16 . In November 2022, the PBAC recommended DOPTELET for chronic immune thrombocytopenia purpura in patients with severe disease who had inadequate response or intolerance to corticosteroids and intravenous immunoglobulin .