Yonsa

Not interchangeable with other abiraterone acetate products. Risk of mineralocorticoid excess; monitor BP, serum potassium, fluid retention at least monthly. Control hypertension and correct hypokalemia before and during treatment. Underlying conditions (eg, heart failure, recent MI, cardiovascular disease, ventricular arrhythmia); monitor closely. Monitor for adrenocortical insufficiency. Stress (may need higher corticosteroid dose). Monitor LFTs prior to starting treatment, every 2 weeks for the first 3 months, and monthly thereafter. Baseline moderate hepatic impairment (Child-Pugh Class B): monitor LFTs prior to initiation, weekly for the first month, every 2 weeks for the next 2 months, and monthly thereafter. Interrupt and reduce dose if hepatotoxicity (ALT/AST >5×ULN or total bilirubin >3×ULN) occurs; see full labeling. Permanently discontinue if concurrent ALT elevation >3×ULN and total bilirubin >2×ULN develops without biliary obstruction or other causes of elevation. Baseline severe hepatic impairment (Child-Pugh Class C): not recommended. Advise males with female partners of reproductive potential to use effective contraception during and for 3 weeks after the last dose. Pregnancy, nursing mothers: not established in females.