Your Health, We Care
Another NameDOPTELET、阿伐曲泊帕、阿伐曲泊帕、苏可欣
IndicationsThrombocytopenia in patients with chronic liver disease and chronic immune disorders.
Reg No.04 L 0959/23
Inspection NO.
Avatrombopag is an orally bioavailable small molecule TPO receptor agonist, initially developed and produced by Eisai Corporation in Japan. The Lucius version of Avatrombopag has a drug specification of 20mg * 28 tablets.
Avatrapexostat was approved for marketing by the US Food and Drug Administration (FDA) in May 2018 for the treatment of adult chronic liver disease (CLD) associated thrombocytopenia and immune thrombocytopenia (ITP) that require selective diagnostic procedures or surgery.
Avatrombopag is an oral, small molecule, non peptide thrombopoietin receptor agonist (TPO-RA). Its main function is to stimulate the proliferation, differentiation, and platelet production of megakaryocytes in the bone marrow, and increase the number of platelets in the blood.
Avatrombopag
Adult patients with thrombocytopenia.
The available data on Avatrombopag in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
Due to the potential for serious adverse reactions in a breastfed child from Avatrombopag, breastfeeding is not recommended during treatment with Avatrombopag and for at least 2 weeks after the last dose.
Safety and effectiveness in pediatric patients have not been established.
Not identified differences in responses between the elderly and younger.
Closely monitor the patient and platelet count. Treat thrombotic complications in accordance with standard of care.
No antidote for Avatrombopag overdose is known.
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store tablets in the original package.
The median time to maximal concentration (Tmax) occurred at 5 to 6 hours post-dose.
from FDA，2021.06
