Generic Name and Formulations:
Abiraterone acetate 125mg; tabs.
Sun Pharmaceutical Industries
Indications for YONSA:
In combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (CRPC).
Swallow whole with water. 500mg once daily (in combination with methylprednisolone 4mg twice daily). Also give concurrent GnRH analog or patient should have had bilateral orchiectomy. Baseline moderate hepatic impairment (Child-Pugh Class B): 125mg once daily; monitor closely; discontinue if ALT/AST >5xULN or total bilirubin >3xULN and do not re-treat. If concomitant strong CYP3A4 inducer necessary, increase abiraterone dose frequency to twice daily during co-administration period (eg, from 500mg once daily to 500mg twice daily); reduce back to previous dose/frequency when CYP3A4 inducer is discontinued.
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. 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 >5xULN or total bilirubin >3xULN) occurs; see full labeling. Permanently discontinue if concurrent ALT elevation >3xULN and total bilirubin >2xULN develops without biliary obstruction or other causes of elevation. Baseline severe hepatic impairment (Child-Pugh Class C): not recommended. Males with female partners of reproductive potential must use effective contraception during therapy and for 3 weeks after last dose. Nursing mothers: not for use in women.
Antagonized by strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); avoid (or see Adult). Potentiates CYP2D6 substrates (eg, dextromethorphan). Avoid concomitant CYP2D6 substrates with narrow therapeutic index (eg, thioridazine); if no alternatives, use caution and consider dose reduction of substrate. Concomitant CYP2C8 substrates with narrow therapeutic index (eg, pioglitazone): monitor closely for toxicity.
Fatigue, joint swelling/discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection, contusion, anemia, elevated LFTs, dyslipidemia, lymphopenia, hyperglycemia, hypophosphatemia, hypokalemia; hepatotoxicity (may be severe).
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