Revolade 50 mg (Eltrombopag Olamine)

Adult dose

1. Chronic immune (idiopathic) thrombocytopenia Initial dose Administer 25mg of this drug once daily. Dose adjustment Do not exceed 50mg daily. If 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 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 based on the results. ※ For patients receiving 25mg/day, consider reducing the dose to 25mg every other day. If platelet count is greater than 400×109/L Discontinue this drug. Increase the frequency of platelet count monitoring to twice per week. When the platelet count falls below 150×109/L, restart treatment; consider restarting at a dose of 25mg or 25mg every other day. If platelet count is greater than 400×109/L after 2 weeks of treatment with the lowest dose of this drug Discontinue this drug. Do not administer more than one dose of this drug within 24 hours. The standard dose adjustment for increasing or decreasing the dose of this drug is to increase or decrease the dose by 25mg once daily. However, some patients may need to combine different doses on alternating days or take the drug less frequently. 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 a subsequent dose increase, it is recommended to increase to the next dose no sooner than 3 weeks later. 2. Thrombocytopenia associated with chronic hepatitis C Initial dose Administer 25mg of this drug once daily. Dose adjustment Adjust the dose by 25mg every 2 weeks to achieve the target platelet count for initiating antiviral therapy. Do not exceed 75mg daily. If 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 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 based on the results. For patients receiving 25mg once daily, consider reducing the dose to 25mg every other day. If platelet count is greater than 400×109/L Discontinue this drug. Increase the frequency of platelet count monitoring to twice per week. When the platelet count falls below 150×109/L, restart treatment with the daily dose reduced by 25mg. For patients receiving 25mg once daily, restart treatment at 25mg every other day. If platelet count is greater than 400×109/L after 2 weeks of treatment with the lowest dose of this drug Discontinue this drug. If antiviral therapy is discontinued, this drug should also be discontinued. 3. Severe aplastic anemia [First-line treatment in patients 2 years of age and older with severe aplastic anemia, in combination with immunosuppressive therapy] Adults and adolescents aged 12-17 years: Administer 75 mg of this drug once daily for 6 months. [Treatment of severe aplastic anemia that has not responded adequately to immunosuppressive therapy] Initial dose Administer 25mg of this drug once daily. Dose adjustment Hematologic response generally requires dose titration up to 100mg and may take up to 16 weeks after treatment initiation. Adjust the dose by 25mg every 2 weeks to achieve and maintain the required platelet count (50×109/L or higher). Do not exceed 100mg daily. If 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 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 based on the results. If platelet count is greater than 400×109/L Interrupt treatment with 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 platelet count is greater than 400×109/L after 2 weeks of treatment with the lowest dose of this drug Discontinue this drug. For patients with a platelet count greater than 50×109/L, a hemoglobin level greater than 10 g/dL without red blood cell transfusions, and an absolute neutrophil count (ANC) greater than 1×109/L for more than 8 weeks, reduce the dose of this drug by 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 re-administered 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 pediatric patients 2 years of age and older and adults with severe aplastic anemia, in combination with immunosuppressive therapy] Adolescents 12-17 years of age: Administer 75 mg of this medicine once daily for 6 months. Children 6-11 years of age: 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 given on alternate days. Children 2-5 years of age: Administer 1.25mg/kg once daily for 6 months. Reduce the dose in children under 12 years of age to 25mg on alternate days. (In children under 12 years of age, consider restarting treatment at a dose of 25mg on alternate days.) There are no data on dose adjustment due to hepatic impairment in pediatric patients. Based on clinical judgment, consider dose adjustment proportionate to the dose adjustment in adults.

This medication can cause liver damage, so frequent liver function tests are necessary. The risk of liver damage is higher in East Asians, so caution is required. If liver function tests indicate poor results or there are symptoms of liver damage, the use of this medication should be discontinued. In cases of severe liver damage, re-administration is not recommended. When this medication is used with other antiviral drugs in patients with chronic hepatitis C, there is a risk of worsening liver function, hence careful monitoring of liver status is essential. This medication may increase the risk of fibrosis in the bone marrow, so if there are changes in blood cell counts or signs of marrow abnormalities, a bone marrow examination should be considered. If platelet counts rise too high, vascular issues such as thrombosis or thromboembolism may occur, so platelet levels should be monitored regularly, and dosages adjusted as needed. This medication can affect blood test results, so if test results are abnormal, consultation with a doctor is necessary. Patients with poor liver function should start this medication at a lower dosage and closely monitor liver function, and careful attention is required for patients with poor kidney function. During pregnancy, this medication may affect the fetus, so women who may become pregnant should use effective contraception during and for a certain period after treatment. Breastfeeding women should consider discontinuing breastfeeding or the medication as it may be passed into breast milk. This medication may interact with other drugs, so if taking other medications, a consultation with a doctor or pharmacist is essential. During the course of this medication, platelet counts and liver function should be regularly tested, and any unusual symptoms should be reported to healthcare professionals immediately.

Abnormal liver function tests, severe hepatotoxicity, liver damage, biliary tract disorders, elevated ALT, elevated AST, elevated bilirubin, abnormal liver function, liver focal failure, bone marrow reticulin and bone marrow fibrosis, thrombotic/thromboembolic complications, pulmonary embolism, deep vein thrombosis, transient ischemic attack, myocardial infarction, ischemic stroke, suspected PRIND symptoms, death, progression of acute myeloid leukemia, serum discoloration, interference with total bilirubin and creatinine tests, pharyngitis, cataract, thromboembolic events, thrombotic microangiopathy with acute renal failure, diarrhea, nausea, vomiting, dry mouth, increased alanine aminotransferase, increased aspartate aminotransferase, hyperbilirubinemia, drug-induced liver injury, rash, hair loss, pain in extremities, myalgia, musculoskeletal pain, anemia, loss of appetite, headache, cough, itching, fever, fatigue, influenza-like illness, weakness, chills, edema, abdominal pain, skin discoloration including hyperpigmentation, increased blood bilirubin including scleral jaundice, purpura, urticaria, gingival bleeding, oral bleeding, infections and parasitic infections, blurred vision, dizziness, oropharyngeal pain, runny nose, limb pain, arthralgia, muscle cramps

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage ensures the safety of the medication's effectiveness.

Appearance

Brown, biconvex, round film-coated tablet

Package unit

28 tablets (7 tablets / PTP package x 4)