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Another NameSCEMBLIX 、asciminib、asciminibum、阿思尼布
IndicationsPhiladelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Reg No.10 L 1034/23
Inspection NO.
Asciminib was originally developed by Novartis and comes in two sizes, 20mg and 40mg, to meet the treatment needs of different patients.
Asciminib was first approved for sale in the United States in January 2021, becoming the world's first approved STAMP inhibitor.
Asciminib effectively inhibits BCR-ABL1 cancer protein kinase activity by specifically targeting ABL myristoyl pocket, reducing the proliferation and spread of leukemia cells.
Asciminib
Patients with specific types of chronic myeloid leukemia (CML).
There are no available data on Asciminib use in pregnant women to evaluate a drug associated risk.Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
There are no data on the presence of Asciminib or its metabolites in human milk, the effects on the breastfed child, or milk production.
Verify the pregnancy status of females of reproductive potential prior to starting treatment with Asciminib.
Females of reproductive potential should use effective contraception during treatment with Asciminib and for 1 week after the last dose.
The safety and efficacy of Asciminib in pediatric patients have not been established.
No differences in safety or efficacy of Asciminib were observed between patients 65 years of age or older compared to younger patients.
There is an insufficient number of patients 75 years of age or older to assess whether there are differences in safety or efficacy.
No dose adjustment is required for patients with mild to severe renal impairment and not requiring dialysis receiving Asciminib.
No dose adjustment is required for patients with mild to severe hepatic impairmentreceiving Asciminib.
Drug overdose is not yet clear.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).Dispense and store in the original container in order to protect from moisture.
The median (range) Tmax of Asciminib is 2.5 hours (2 to 3 hours).
from FDA,2021.10
