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Another Name达普司他、达度司他
Indicationsdaprodustat is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
Reg No.06 L 1114/24
Inspection NO.
Daprodustat stabilizes hypoxia inducible factor (HIF) by inhibiting the structural domain of prolyl hydroxylase, thereby increasing endogenous erythropoietin (EPO) production, improving iron absorption, and downregulating ferritin levels, thereby promoting red blood cell synthesis and treating anemia.
Daprodustat has completed multiple phase III clinical trials and demonstrated positive efficacy in both non dialysis dependent and dialysis dependent adult patients with chronic kidney disease anemia, without increasing cardiovascular risk.
Daprodustat
daprodustat is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months.
Available data with daprodustat use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with CKD.
There are no data on the presence of daprodustat in human milk, the effects on the breastfed child, or the effects on milk production.
No other reported clinical experience has identified differences in responses between the elderly and younger patients.
Safety and effectiveness of daprodustat in pediatric patients have not been established.
No adjustment of the starting dose is required in patients with mild hepatic impairment Reduce the starting dose of daprodustat by half in patients with moderate hepatic impairment except in patients whose starting dose is already 1 mg. daprodustat has not been studied in patients with severe hepatic impairment. Therefore, daprodustat is not recommended in patients with severe hepatic impairment.
Headache and gastrointestinal adverse reactions (e.g., nausea) may be seen with acute overdose with daprodustat. There is no specific antidote. Hemodialysis will not substantially remove daprodustat because it is highly protein bound.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F).
Daprodustat exposure generally increases in a dose-proportional manner over the range of approved doses. Steady-state concentrations are achieved within 24-hours of dosing.
from FDA，2023.02
