GSK Eltrombopag_ Revolade 25mg*14 tablets/bottle (box)ThrombocytopeniaApplicable during treatment with this drug

【Indications】

• This product is suitable for adults (≥18 years old) with chronic immune (idiopathic) thrombocytopenia (ITP) who have previously had poor response to glucocorticoids, immunoglobulins, etc., to increase platelet count and reduce or prevent Bleeding.
• This product should only be used in patients with ITP due to thrombocytopenia and clinical conditions that increase the risk of bleeding.

【Dosage】

• The lowest dose that achieves and maintains a platelet count of ≥50,000/µL should be used. Individualize dosage adjustments based on platelet count response. This product should not be used to normalize a patient's platelet count. In clinical studies, platelet counts generally increased within 1 to 2 weeks after the initiation of treatment with this product and decreased within 1 to 2 weeks after the discontinuation of treatment.
• This product should be taken on an empty stomach (1 hour before meals or 2 hours after meals), and should be taken at least 2 hours before or 4 hours after the following products, including antacids, dairy products, or products containing polyvalent Mineral supplements for cations such as aluminum, calcium, iron, magnesium, selenium and zinc. This product should not be crushed and mixed with food or liquids.

Initial dosing regimen

Adult patients

• After starting treatment with this product, adjust the dose if necessary to achieve and maintain a platelet count of ≥50,000/µL to reduce the risk of bleeding. Dosage should not exceed 75 mg daily. After 4 weeks of once-daily dosing, if the platelet count has not increased to a level sufficient to avoid clinically significant bleeding, treatment with this product should be discontinued.
• If obvious liver function abnormalities occur, discontinuation of this product should also be considered. Routine blood tests, including platelet counts, should continue to be monitored once weekly for at least 4 weeks after discontinuation of treatment.

other people

• Renal Impairment: No dosage adjustment is required in patients with renal impairment. However, due to limited clinical experience, this product should be used with caution and close monitoring in patients with renal impairment.
• Hepatic Impairment: ITP patients with cirrhosis (hepatic impairment, Child-Pugh score ≥5) should use this product with caution and monitor closely.

elderly

• There are limited data on the use of this product in patients aged ≥65 years, and there is no experience in patients over 85 years of age. In clinical studies of this product, there were overall no clinically significant differences in the safety of this product between subjects aged ≥65 years and younger subjects. Other reported clinical experiences have also found no difference in efficacy between older and younger patients, but it cannot be ruled out that individual older patients may be more sensitive to the drug.

【Adverse reactions】

• In the ITP studies, the most important serious adverse reactions identified were hepatotoxicity and thrombosis/thrombotic events.
• In ITP studies, the most common adverse reactions of all grades (occurring in at least 10% of patients) include: headache, anemia, decreased appetite, insomnia, cough, nausea, diarrhea, alopecia, pruritus, myalgia, pyrexia, fatigue, influenza disease, weakness, chills, and peripheral edema.

【Storage】

• Store below 30°C and keep out of reach of children.