Eltrombopag tablets are indicated for:

• Management of thrombocytopenia in patients with chronic or persistent immune thrombocytopenia.
• Treatment of thrombocytopenia associated with hepatitis C infection.
• Treatment of severe aplastic anemia.

Limitations of Use: Eltrombopag is not recommended for patients with myelodysplastic syndromes (MDS). Its safety and effectiveness have not been established when used with direct-acting antiviral agents without interferon in the treatment of chronic hepatitis C.

Eltrombopag olamine is a small-molecule thrombopoietin (TPO) receptor agonist. It binds to the transmembrane domain of the human TPO receptor and activates intracellular signaling pathways that stimulate the proliferation and differentiation of bone marrow progenitor cells, ultimately leading to increased platelet production.

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.

Drug interaction with medication: Eltrombopag should be taken at least 2 hours before or 4 hours after medications or supplements containing polyvalent cations such as antacids, iron, calcium, aluminum, magnesium, selenium, or zinc.

Drug interaction with food and others: Eltrombopag should be administered at least 2 hours before or 4 hours after consuming calcium-rich foods.

Eltrombopag is contraindicated in patients with known hypersensitivity to eltrombopag or any of its components.

Common adverse effects include anemia, nausea, fever (pyrexia), increased ALT levels, cough, fatigue, headache, and diarrhea.

There is insufficient information to determine the risk of major birth defects, miscarriage, or other adverse outcomes associated with eltrombopag use during pregnancy. It is also unknown whether eltrombopag or its metabolites are present in human milk or affect the breastfed infant or milk production. Due to the potential risk of serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment.

In patients with chronic hepatitis C, the use of eltrombopag in combination with interferon and ribavirin may increase the risk of hepatic decompensation. Liver function should be monitored before and during treatment. There is also an increased risk of progression from myelodysplastic syndromes to acute myeloid leukemia and risk of death. Portal vein thrombosis has been reported in patients with chronic liver disease receiving eltrombopag. Regular monitoring of platelet counts is recommended.

Use in children and adolescents: Safety and effectiveness in children below 1 year of age with immune thrombocytopenia have not been established. Similarly, safety and efficacy in pediatric patients with thrombocytopenia due to chronic hepatitis C or severe aplastic anemia are not established.

In cases of overdose, platelet counts may rise excessively, increasing the risk of thrombotic or thromboembolic events. Administration of metal cation-containing preparations (such as calcium, aluminum, or magnesium) may help reduce absorption by binding eltrombopag.

Cytotoxic chemotherapy, haemostatic agent.

Store below 25°C in a cool, dry place, protected from light. Keep out of reach of children.