Prostate and other male cancers:

Indications for YONSA:

In combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (CRPC).

Adult:

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 >5×ULN or total bilirubin >3×ULN and do not re-treat. Hepatotoxicity: see full labeling. 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.

Children:

Not established.

Warnings/Precautions:

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.

Pharmacologic Class:

CYP17 inhibitor.

Interactions:

Increased fractures and mortality with radium 223 dichloride; avoid concomitant use. Antagonized by strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital); avoid (or see Adult dose). 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.

Adverse Reactions:

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).

Generic Availability:

NO

How Supplied:

Tabs—120

Pricing for YONSA

125mg tablet (Qty: 120)
Appx. price $9685
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