Eltrombopag Olamine tablets are used for the treatment of thrombocytopenia (low platelet count) in the following conditions:

• Persistent or chronic immune thrombocytopenia (ITP) in patients who do not respond adequately to other treatments.
• Thrombocytopenia in patients with chronic hepatitis C infection, to help maintain platelet levels during antiviral therapy.
• Severe aplastic anemia (SAA) to help increase platelet production in patients with bone marrow failure.

Limitations of Use: Eltrombopag tablets are not indicated for the treatment of patients with myelodysplastic syndromes (MDS). The safety and effectiveness of eltrombopag in combination with direct-acting antiviral agents used without interferon for chronic hepatitis C infection have not been established.

Eltrombopag Olamine is a small-molecule thrombopoietin (TPO) receptor agonist. It binds to the transmembrane domain of the human thrombopoietin receptor and activates intracellular signaling pathways. This activation stimulates the proliferation and differentiation of bone marrow progenitor cells, which ultimately leads to increased platelet production in the blood.

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 × 10⁹/L as necessary. Do not exceed a dose of 150 mg per day.

Drug interactions with medications: Eltrombopag should be taken at least 2 hours before or 4 hours after medicines or products that contain polyvalent cations, such as antacids or mineral supplements. These include products containing iron, calcium, aluminum, magnesium, selenium, or zinc, which may reduce the absorption of eltrombopag.

Drug interactions with food and other substances: Eltrombopag should also be taken at least 2 hours before or 4 hours after consuming calcium-rich foods, as calcium may interfere with the absorption of the medicine.

Eltrombopag is contraindicated in patients who have a known hypersensitivity or allergic reaction to eltrombopag or any of the ingredients in this product.

The most commonly reported side effects include anaemia, nausea, fever (pyrexia), elevated ALT levels, cough, fatigue, headache, and diarrhoea.

There are insufficient data available to determine whether eltrombopag increases the risk of major birth defects, miscarriage, or other adverse outcomes during pregnancy. There is also no information regarding the presence of eltrombopag in human breast milk, its effect on breastfed infants, or its effect on milk production. Due to the potential risk of serious adverse reactions in nursing infants, breastfeeding is not recommended during treatment with eltrombopag.

In patients with chronic hepatitis C, the use of eltrombopag together with interferon and ribavirin may increase the risk of hepatic decompensation. Liver function tests should be monitored before starting treatment and regularly during therapy. There is also an increased risk of death and progression of myelodysplastic syndrome (MDS) to acute myeloid leukemia (AML) in certain patients. In patients with chronic liver disease, cases of portal vein thrombosis have been reported during eltrombopag therapy. Platelet counts should be monitored regularly to reduce the risk of complications.

Children and Adolescents: The safety and effectiveness of eltrombopag in children under 1 year of age with immune thrombocytopenia (ITP) have not been established. Similarly, the safety and effectiveness of eltrombopag in pediatric patients with thrombocytopenia associated with chronic hepatitis C or refractory severe aplastic anemia have not been confirmed.

In case of eltrombopag overdose, platelet counts may rise excessively, which may increase the risk of thrombosis or thromboembolic complications. If overdose occurs, oral administration of preparations containing metal cations (such as calcium, aluminum, or magnesium) may be considered. These substances may bind to eltrombopag and help reduce its absorption.

Cytotoxic Chemotherapy, Haemostatic drugs

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