Idiopag® tablets contain eltrombopag olamine, a small-molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl), leading to increased platelet production.

Eltrombopag olamine is a thrombopoietin receptor agonist indicated for the treatment of:

Thrombocytopenia in adult and pediatric patients (1 year and older) with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Eltrombopag should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increases the risk of bleeding.

Thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. Eltrombopag should be used only in patients with chronic hepatitis C whose degree of thrombocytopenia prevents the initiation of interferon-based therapy or limits the ability to maintain interferon-based therapy.

Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.

Take on an empty stomach (1 hour before or 2 hours after a meal).

Chronic ITP: Initiate eltrombopag at 50 mg once daily for most adult and pediatric patients aged 6 years and older and at 25 mg once daily for pediatric patients aged 1 to 5 years. Dose reductions are needed for patients with hepatic impairment. Adjust to maintain a platelet count greater than or equal to 50 × 10⁹/L. Do not exceed 75 mg per day.

Chronic Hepatitis C-associated Thrombocytopenia: Initiate eltrombopag at 25 mg once daily for all patients. Adjust to achieve the target platelet count required to initiate antiviral therapy. Do not exceed a daily dose of 100 mg.

Severe Aplastic Anemia: Initiate eltrombopag at 50 mg once daily for most patients. Reduce the initial dose in patients with hepatic impairment or patients of East Asian ancestry. Adjust to maintain a platelet count greater than 50 × 10⁹/L. Do not exceed 150 mg per day.

Hepatotoxicity: Monitor liver function before and during therapy.

Thrombotic/Thromboembolic Complications: Portal vein thrombosis has been reported in patients with chronic liver disease receiving eltrombopag. Monitor platelet counts regularly.

In adult patients with ITP, the most common adverse reactions were nausea, diarrhea, upper respiratory tract infection, vomiting, increased ALT, myalgia, and urinary tract infection.

In pediatric patients aged 1 year and older with ITP, the most common adverse reactions were upper respiratory tract infection and nasopharyngitis.

In patients with chronic hepatitis C-associated thrombocytopenia, the most common adverse reactions were anemia, pyrexia, fatigue, headache, nausea, diarrhea, decreased appetite, influenza-like illness, asthenia, insomnia, cough, pruritus, chills, myalgia, alopecia, and peripheral edema.

In patients with severe aplastic anemia, the most common adverse reactions were nausea, fatigue, cough, diarrhea, and headache.

Pregnancy: Pregnancy category C. Based on animal data, eltrombopag olamine may cause fetal harm.

Nursing Mothers: A decision should be made to discontinue eltrombopag olamine or nursing, taking into account the importance of eltrombopag olamine to the mother.

Polyvalent cations significantly reduce the absorption of eltrombopag olamine. Take eltrombopag at least 2 hours before or 4 hours after any medications or products containing polyvalent cations, such as antacids, calcium-rich foods, and mineral supplements.

In the event of an overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic complications. In case of an overdose, consideration should be given to oral administration of a metal cation-containing preparation, such as calcium, aluminum, or magnesium preparations, to chelate eltrombopag olamine and thus limit absorption. Platelet counts should be closely monitored. Treatment with eltrombopag olamine should be reinitiated in accordance with dosing and administration recommendations.

Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.

Medicine: Keep out of reach of children.