ETP
Generic Name:Eltrombopag Olamine
Indications
ETP is indicated for-
- Treatment of thrombocytopenia in patients with persistent or chronic immune thrombocytopenia
- Treatment of thrombocytopenia in patients with hepatitis C infection
- Treatment of severe aplastic anemia
Limitations of use: ETP is not indicated for the treatment of patients with myelodysplastic syndromes (MDS). Safety and efficacy have not been established in combination with direct-acting antiviral agents used without interferon for the treatment of chronic hepatitis C infection.
Pharmacology
Eltrombopag Olamine is a small molecule thrombopoietin (TPO) receptor agonist. Eltrombopag interacts with the transmembrane domain of the human TPO-receptor and initiates signaling cascades that induce proliferation and differentiation from bone marrow progenitor cells finally leading to increased platelet production.
Dosage & Administration
Route of administration: Eltrombopag tablet should be taken in oral route and it can be taken without a meal or with a meal low in calcium (<50 mg).
Persistent or chronic immune thrombocytopenia: Use the lowest dose of Eltrombopag to achieve and maintain a platelet count greater than or equal to 50×109/L as necessary to reduce the risk for bleeding. Do not exceed a dose of 75 mg daily.
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 Asian ancestry or who have mild to severe hepatic impairment. For patients of 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, initiate Eltrombopag at a reduced dose of 25 mg once daily. For patients of Asian ancestry with ITP and hepatic impairment, 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.
Chronic hepatitis C associated thrombocytopenia: Initiate Eltrombopag at a dose of 25 mg once daily. Adjust the dose of Eltrombopag in 25 mg increments every 2 weeks as necessary to achieve the target platelet count required to initiate antiviral therapy. Do not exceed a dose of 100 mg daily.
First line severe aplastic anemia: Initiate Eltrombopag once daily at 2.5 mg/kg (in pediatric patients aged 2 to 5 years old), 75 mg (pediatric patients aged 6 to 11 years old) or 150 mg for patients aged 12 years and older for 6 months concurrently with standard immunosuppressive therapy. For patients of Asian ancestry or those with mild, moderate or severe hepatic impairment, decrease the initial dose by 50%. Modify the dose regimen of Eltrombopag based on platelet counts, ALT or AST elevations and thromboembolic events.
Refractory severe aplastic anemia: Initiate Eltrombopag at 50 mg once daily. Hematologic response requires dose titration, generally up to 150 mg and may take up to 16 weeks after starting Eltrombopag. For patients of Asian ancestry or those with mild, moderate, or severe hepatic impairment, initiate Eltrombopag at a reduced dose of 25 mg once daily. Adjust the dose of Eltrombopag in 50 mg increments every 2 weeks as necessary to achieve the target platelet count greater than or equal to 50 x 109/L as necessary. Do not exceed a dose of 150 mg per day.
