Elpack 25 mg (Eltrombopag Olamine)

Adult dose

1. Chronic immune (idiopathic) thrombocytopenia Initial dose: Administer this drug 25mg once daily. Do not exceed 50mg per day. If the platelet count is less than 50×109/L after treatment with this drug for at least 2 weeks: Increase the daily dose by 25mg, up to a maximum of 50mg/day. For patients whose dose was reduced to 25mg every other day, consider increasing the dose to 25mg/day. If the platelet count is 200×109/L or higher～400×109/L or lower: Reduce the daily dose by 25mg. Reassess after 2 weeks and adjust the dose according to the results. For patients receiving 25mg/day, consider reducing the dose to 25mg every other day. If the platelet count is greater than 400×109/L: Discontinue this drug. When the platelet count falls below 150×109/L, restart treatment; consider restarting at 25mg or 25mg every other day. If the platelet count is greater than 400×109/L after 2 weeks of treatment at the lowest dose of this drug: Discontinue this drug. The standard dose adjustment for increasing or decreasing the dose of this drug is to increase or decrease it by 25mg once daily. Some patients may need different doses on alternating days or less frequent administration. If, after 4 weeks of treatment at the maximum daily dose of 50mg, the platelet count has not increased to a level sufficient to prevent clinically significant bleeding, discontinue this drug. For patients with hepatic impairment (Child-Pugh class A, B, or C), administer an initial dose of 25mg every other day. For patients with hepatic impairment (Child-Pugh class A, B, or C), after the initial dose or any subsequent dose increase, it is recommended that the next dose increase be made no sooner than 3 weeks later. 2. Thrombocytopenia associated with chronic hepatitis C Initial dose: Administer this drug 25mg once daily. Adjust the dose by 25mg every 2 weeks to achieve the target platelet count for initiating antiviral therapy. Do not exceed 75mg per day. If the platelet count is less than 50×109/L after treatment with this drug for at least 2 weeks: Increase the daily dose by 25mg, up to a maximum of 75mg/day. If the platelet count is 200×109/L or higher～400×109/L or lower: Reduce the daily dose by 25mg. Reassess after 2 weeks and adjust the dose according to the results. For patients receiving 25mg once daily, consider reducing the dose to 25mg every other day. If the platelet count is greater than 400×109/L: Discontinue this drug. When the platelet count falls below 150×109/L, restart treatment at a daily dose reduced by 25mg. For patients receiving 25mg once daily, restart treatment at 25mg every other day. If the platelet count is greater than 400×109/L after 2 weeks of treatment at the lowest dose of this drug: Discontinue this drug. If antiviral therapy is discontinued, this drug must also be discontinued. 3. Severe aplastic anemia First-line treatment of severe aplastic anemia in pediatric patients aged 2 years and older and adults, in combination with immunosuppressive therapy Initial dose: Adults: Administer this drug 75 mg once daily for 6 months. For first-line treatment of severe aplastic anemia, if the platelet count is greater than 200×109/L～400×109/L or lower: Reduce the daily dose by 25mg every 2 weeks to the lowest dose that maintains a platelet count of at least 50×109/L. For patients receiving 25mg once daily, reduce the dose by administering 25mg every other day. If the platelet count is greater than 400×109/L: Discontinue this drug for 1 week. When the platelet count falls below 200×109/L, restart treatment; consider restarting at a dose reduced by 25mg. Abnormal liver function tests: If ALT increases to greater than 6 times the upper limit of normal, discontinue this drug. If ALT is less than 5 times the upper limit of normal, resume this drug at the same dose. If ALT increases to greater than 6 times the upper limit of normal after resuming treatment, discontinue this drug. If ALT is less than 5 times the upper limit of normal, resume once-daily treatment with this drug at a daily dose reduced by 25mg from the previous dose. If ALT increases again to greater than 6 times the upper limit of normal while receiving the reduced dose, reduce the daily dose of this drug by 25mg until ALT is less than 5 times the upper limit of normal. The total treatment duration with this drug is 6 months. Treatment of severe aplastic anemia with an inadequate response to immunosuppressive therapy Initial dose: Administer this drug 25mg once daily. Adjust the dose by 25mg every 2 weeks to achieve and maintain the required platelet count (at least 50×109/L). Do not exceed 100mg per day. If the platelet count is less than 50×109/L after treatment with this drug for at least 2 weeks: Increase the daily dose by 25mg, up to a maximum of 100mg/day. If the platelet count is 200×109/L or higher～400×109/L or lower: Reduce the daily dose by 25mg. Reassess after 2 weeks and adjust the dose according to the results. If the platelet count is greater than 400×109/L: Discontinue this drug for 1 week. When the platelet count falls below 150×109/L, restart treatment; consider restarting at a dose reduced by 25mg. If the platelet count is greater than 400×109/L after 2 weeks of treatment at the lowest dose of this drug: Discontinue this drug. For patients whose platelet count is greater than 50×109/L, hemoglobin level is greater than 10 g/dL without red blood cell transfusions, and absolute neutrophil count (ANC) is greater than 1×109/L for 8 weeks or longer, reduce the dose of this drug by up to 50%. If the platelet count remains stable after 8 weeks at the reduced dose, discontinue this drug and monitor blood counts. If the platelet count falls below 30×109/L, the hemoglobin level falls below 9g/dL, or the absolute neutrophil count (ANC) falls below 0.5×109/L, this drug may be restarted at the previous dose. If no hematologic response occurs after 16 weeks of treatment with this drug, discontinue this drug.

Child dose

3. Severe aplastic anemia First-line treatment, in combination with immunosuppressive therapy, for patients with severe aplastic anemia aged 2 years and older Initial dose Adolescents aged 12-17 years: Administer 75 mg of this medicine once daily for 6 months. Children aged 6-11 years: Administer 37.5 mg of this medicine once daily for 6 months. To administer 37.5 mg of this medicine once daily, 25 mg and 50 mg of this medicine may be administered on alternate days. Children aged 2-5 years: Administer 1.25mg/kg of this medicine once daily for 6 months. If the platelet count is >200×109/L to ≤400×109/L: Reduce the dose for children under 12 years of age to 25mg on alternate days. If the platelet count is >400×109/L: Once the platelet count is <200×109/L, restart treatment; for children under 12 years of age, consider restarting treatment at a dose of 25mg on alternate days.

This medication can potentially cause liver damage, hence liver function tests should be conducted frequently before and during treatment. Special caution is required for patients of East Asian descent or with chronic liver disease, as their risk of liver damage is higher. If there is a significant increase in liver function tests or symptoms of liver damage arise, administration must be stopped immediately. While this medication increases platelet counts in the blood, excessive levels may lead to thrombus formation; therefore, platelet counts should be monitored regularly. Patients at risk of thrombosis or with significant liver disease should use this drug with increased caution. There is a possibility of developing bone marrow fibrosis, so blood cell counts or symptoms warranting a bone marrow examination should be considered. Women who are pregnant or may become pregnant should consult a doctor before use, as it may affect the fetus. This medication can interact with other drugs, thus patients should inform their doctors of any medications being taken. Blood test results can be influenced by the color of this medication, so caution is required in interpreting test results. Children, elderly individuals, and patients with impaired kidney or liver function should consult a doctor before use and be closely monitored during treatment. In case of overdose, excessively elevated platelet counts may increase the risk of thrombosis, thus adherence to the specified dosage is crucial.

• Abnormal liver and bile duct tests
• severe hepatotoxicity
• liver damage
• cholestatic disorders
• elevated bilirubin
• abnormal liver function
• thrombotic microangiopathy
• thromboembolic events
• pulmonary embolism
• deep vein thrombosis

This medication should be stored in a tightly sealed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance

White, round, biconvex film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP X 4]