Revolade 25 mg Tablets (Eltrombopag)

Adult dose

1. Chronic immune (idiopathic) thrombocytopenia Initial dose Administer 25mg of this drug once daily. Dose adjustment Do not exceed 50mg per day. If the platelet count is <50×109/L after at least 2 weeks of treatment with this drug: 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 to ≤400×109/L: 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 >400×109/L: discontinue this drug. Increase the frequency of platelet count monitoring to twice weekly. When the platelet count is <150×109/L, restart treatment; consider restarting at 25mg or 25mg every other day. If the platelet count is >400×109/L after 2 weeks at the lowest dose of this drug: discontinue this drug. Do not administer more than a single 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 by 25mg once daily. However, some patients may require different doses on alternate days or less frequent administration. After a dose adjustment, monitor the platelet count at least once weekly for 2–3 weeks. Wait at least 2 weeks to assess the effect of the dose adjustment on the patient's platelet response before considering a further dose increase. For patients with cirrhosis (i.e., hepatic impairment), wait 3 weeks before increasing the dose. If the platelet count does not increase to a level sufficient to prevent clinically significant bleeding after 4 weeks at the maximum daily dose of 50mg, 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 wait 3 weeks before increasing to the next dose. 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 per day. If the platelet count is <50×109/L after at least 2 weeks of treatment with this drug: increase the daily dose by 25mg, up to a maximum of 75mg/day. If the platelet count is ≥200×109/L to ≤400×109/L: 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 >400×109/L: discontinue this drug. Increase the frequency of platelet count monitoring to twice weekly. When the platelet count is <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 >400×109/L after 2 weeks 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 and adolescents aged 12-17 years: Administer 75 mg of this drug once daily for 6 months. [Treatment of severe aplastic anemia with an insufficient response to immunosuppressive therapy] Initial dose Administer 25mg of this drug once daily. Dose adjustment A hematologic response generally requires dose titration up to 100mg and may take up to 16 weeks after starting treatment. Adjust the dose by 25mg every 2 weeks to achieve and maintain the required platelet count (≥50×109/L). Do not exceed 100mg per day. If the platelet count is <50×109/L after at least 2 weeks of treatment with this drug: increase the daily dose by 25mg, up to a maximum of 100mg/day. If the platelet count is ≥200×109/L to ≤400×109/L: reduce the daily dose by 25mg. Reassess after 2 weeks and adjust the dose according to the results. If the platelet count is >400×109/L: withhold this drug for 1 week. When the platelet count is <150×109/L, restart treatment; consider restarting at a dose reduced by 25mg. If the platelet count is >400×109/L after 2 weeks at the lowest dose of this drug: discontinue this drug. For patients with a platelet count >50×109/L, hemoglobin level >10 g/dL without red blood cell transfusions, and absolute neutrophil count (ANC) >1×109/L for more than 8 weeks, 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.

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. If the platelet count is >200×109/L and ≤400×109/L: Reduce the dose in children under 12 years of age to 25mg on alternate days. If the platelet count is >400×109/L: When the platelet count falls below 200×109/L, restart treatment; consider restarting at a dose reduced by 25mg (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 may burden the liver, so liver function tests must be performed before use, and regular monitoring of liver function during treatment is essential. Particularly, liver dysfunction may occur more frequently in East Asians, thus requiring increased caution. If liver enzyme levels rise above certain thresholds or symptoms of liver damage appear, this medication should be stopped immediately. In chronic hepatitis C patients with liver cirrhosis, the combination of this medication with other antiviral agents may increase the risk of liver function deterioration and requires careful observation. Increased fibrous tissue in the bone marrow may be observed, so bone marrow examination should be considered if abnormalities in blood cells are found. If platelet counts rise above the normal range, the risk of thrombosis may increase, so platelet counts should be monitored regularly and dosage adjusted if necessary. This medication should be carefully administered to patients with chronic liver disease, and patients at high risk of thrombosis require special attention. This drug may increase the risk of death and progression to acute leukemia in certain blood cancer patients, so its use in these patients should either be avoided or carefully considered. This drug may affect blood test results, so care is needed when interpreting test results. During pregnancy, it may affect the fetus, so women of childbearing potential should use effective contraception during and for a certain period after treatment. Breastfeeding women should carefully decide their breastfeeding status due to the possibility of this drug being transmitted through breast milk. Safety and efficacy in children, especially in those under 2 years old, have not been established, so caution is advised. Elderly patients can use it without specific dosage adjustments; however, care should be taken according to individual patient conditions. Patients with diminished liver or kidney function may have altered body concentrations of this drug, necessitating dosage adjustments and close monitoring. Overdose of this medication may excessively increase platelet counts, leading to a higher risk of thrombosis; therefore, if overdose occurs, immediate consultation with medical staff is required. It may interact with other medications, so patients must inform their doctor or pharmacist about any other medications being taken, particularly caution is required when combined with antacids, mineral supplements, certain antibiotics, and antivirals.

Abnormal liver and biliary tract tests, severe hepatotoxicity, liver damage, cholestatic disorders, elevated bilirubin, abnormal liver function, clinical symptoms of liver damage, evidence of target organ failure due to liver disease, liver failure, ascites, encephalopathy, thrombotic microangiopathy, thromboembolic events, pulmonary embolism, deep vein thrombosis, transient ischemic attack, myocardial infarction, ischemic stroke, symptoms suspicious for PRIND, thrombosis, death, acute myeloid leukemia, serum discoloration, interference with total bilirubin tests, interference with creatinine tests, pharyngitis, cataracts, thromboembolic events, diarrhea, nausea, vomiting, dry mouth, increased alanine aminotransferase, increased aspartate aminotransferase, hyperbilirubinemia, drug-induced liver injury, rash, alopecia, pain in the neck, myalgia, musculoskeletal pain, anemia, decreased appetite, headache, cough, pruritus, fever, fatigue, influenza-like illness, asthenia, chills, edema, abdominal pain, skin hyperpigmentation, elevated bilirubin levels, limb pain, arthralgia, muscle cramps, purpura, urticaria, gum bleeding, oral bleeding, infections and parasitic infections, herpes zoster, decreased neutrophils, thrombocytopenia, blurred vision, increased AST, abnormal liver function, bradycardia

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the drug's effectiveness and ensures safe use.

Appearance

White, biconvex, round film-coated tablet

Package unit

28 tablets (7 tablets / PTP packaging x 4)