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Another NamePROMACTA、艾曲波帕、艾曲博帕、瑞弗兰、艾曲泊帕乙醇胺片
IndicationsTreat thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.
Reg No.05 L 0969/23
Inspection NO.
Eltrombopag is a thrombopoietin receptor agonist developed and produced by Novartis in Switzerland. It was launched in the United States on November 20, 2008.
Eltrombopa is suitable for patients with various types of thrombocytopenia. The Lucius version of Eltrombopa comes in two sizes: 25mg * 28tablets and 50mg * 28tablets. Patients can choose according to their specific situation.
Eltrombopag promotes platelet production and increases platelet count by stimulating the thrombopoietin receptor in the bone marrow. This mechanism of action helps prevent or alleviate bleeding symptoms caused by platelet deficiency.
Eltrombopag
Patients with advanced renal cell carcinoma, differentiated thyroid carcinoma, advanced non-small cell lung cancer, liver cancer, and advanced prostate cancer.
Available data from a small number of published case reports and postmarketing experience with PROMACTA use in pregnant women are insufficient to assess any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes.
There are no data regarding the presence of eltrombopag or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
PROMACTA can cause fetal harm when administered to a pregnant woman. Sexually-active females of reproductive potential should use effective contraception when using PROMACTA during treatment and for at least 7 days after stopping treatment with PROMACTA
Safety and efficacy in pediatric patients below the age of 1 year with ITP have not been established. Safety and efficacy in pediatric patients with thrombocytopenia associated with chronic hepatitis C and refractory severe aplastic anemia have not been established.
No overall differences in safety or effectiveness were observed between these patients and younger patients.
If a patient with hepatic impairment (Child-Pugh Class A, B, C) initiates therapy with PROMACTA for the firstline treatment of severe aplastic anemia, reduce the initial dose.
No dosage adjustment is recommended in patients with chronic hepatitis C and hepatic impairment.
Reduce the initial dose of PROMACTA for patients of East-/Southeast-Asian ancestry with ITP or severe aplastic anemia，No reduction in the initial dose of PROMACTA is recommended in patients of East-/Southeast-Asian ethnicity with chronic hepatitis C
In the event of overdose, platelet counts may increase excessively and result in thrombotic/thromboembolic.
complications.
Store at room temperature between 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).Following reconstitution, the product should be administered immediately but may be stored for a maximum period of 30 minutes between 20°C to 25°C.excursions permitted between 15°C and 30°C (59°F and 86°F).Throw away (discard) the mixture if not used within 30 minutes.
Eltrombopag is absorbed with a peak concentration occurring 2 to 6 hours after oral administration. Oral absorption of drug-related material following administration of a single 75-mg solution dose was estimated to be at least 52%.
from FDA，2021.10
