Dosage of Eltrombopag

Persistent or Chronic Immune Thrombocytopenia

Use the lowest dose of Eltrombopag to achieve and maintain a platelet count greater than or equal to 50 x 109 /L as necessary to reduce the risk for bleeding. Dose adjustments are based upon the platelet count response. Do not use Eltrombopag to normalize platelet counts. In clinical trials, platelet counts generally increased within 1 to 2 weeks after starting Eltrombopag and decreased within 1 to 2 weeks after discontinuing Eltrombopag.

Initial Dose Regimen: Adult and Pediatric Patients 6 Years and Older with ITP: Initiate Eltrombopag at a dose of 50 mg once daily, except in patients who are of East-/Southeast-Asian ancestry or who have mild to severe hepatic impairment (Child-Pugh Class A, B, C).

For patients of East-/Southeast-Asian ancestry with ITP, initiate Eltrombopag at a reduced dose of 25 mg once daily.

For patients with ITP and mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, C), initiate Eltrombopag at a reduced dose of 25 mg once daily.

For patients of East-/Southeast-Asian ancestry with ITP and hepatic impairment (Child-Pugh Class A, B, C), consider initiating Eltrombopag at a reduced dose of 12.5 mg once daily.

Pediatric Patients with ITP Aged 1 to 5 Years: Initiate Eltrombopag at a dose of 25 mg once daily.

Monitoring and Dose Adjustment: After initiating Eltrombopag, adjust the dose to achieve and maintain a platelet count greater than or equal to 50 x 109 /L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily. Monitor clinical hematology and liver tests regularly throughout therapy with Eltrombopag and modify the dosage regimen of Eltrombopag based on platelet counts as outlined in Table 1. During therapy with Eltrombopag, assess complete blood counts (CBCs) with differentials, including platelet counts, weekly until a stable platelet count has been achieved. Obtain CBCs with differentials, including platelet counts, monthly thereafter.

When switching between the oral suspension and tablet, assess platelet counts weekly for 2 weeks, and then follow standard monthly monitoring. 

from FDA，2021.10