Vadadustat

　　【Indications】

　　This product is a hypoxia-inducible factor prolyl hydroxylase(HIF-PH)inhibitor indicated for the treatment of anemia due to chronic kidney disease(CKD)in adult patients who have been receiving dialysis for a minimum of three months.

　　Limitations of Use:

　　-This product has not been demonstrated to improve quality of life,fatigue,or overall well-being.

　　-This product is not indicated for:

　　Use as a substitute for red blood cell transfusion in patients requiring urgent transfusion therapy.

　　Anemia due to chronic kidney disease(CKD)in patients not receiving dialysis.

　　【Recommended Dosage】

　　The recommended initial dose is 300 mg taken orally once daily.Administration may occur with or without food.

　　【Adverse Reactions】

　　The most frequently reported adverse reactions(incidence≥10%)include elevated blood pressure and diarrhea.

　　【Pharmacology】

　　This product functions as a reversible inhibitor of HIF-prolyl-4-hydroxylase enzymes PH1,PH2,and PH3,with half-maximal inhibitory concentrations(IC50)in the nanomolar(nM)range.This inhibitory activity results in the stabilization and nuclear accumulation of HIF-1αand HIF-2αtranscription factors,thereby enhancing endogenous erythropoietin(EPO)production.

　　【Storage】

　　-Store at controlled room temperature between 20°C and 25°C,with excursions permitted between 15°C and 30°C.

　　-Keep this product out of reach of children.