FDA Approves Abiraterone Acetate (Yonsa) for Metastatic Castration-Resistant Prostate Cancer

Abiraterone acetate is a CYP17 inhibitor. It inhibits androgen biosynthesis.

Abiraterone acetate is indicated in combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

The recommended dose is 500 mg (four 125 mg tablets) orally once daily in combination with methylprednisolone 4 mg orally twice daily. Tablets must be taken as a single dose once daily with or without food, swallowed whole with water. Do not crush or chew. Patients should also receive a GnRH analog or have had bilateral orchiectomy. For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce starting dose to 125 mg once daily. For hepatotoxicity, hold treatment and may restart at reduced doses (375 mg or 250 mg once daily) after recovery. Avoid strong CYP3A4 inducers; if co-administration is necessary, increase abiraterone acetate dosing frequency to twice daily during co-administration.

The efficacy and safety of abiraterone acetate with prednisone in patients with metastatic CRPC that progressed on androgen deprivation therapy were demonstrated in two randomized, placebo-controlled international studies. Patients with prior ketoconazole treatment or adrenal/pituitary disorders were excluded. Concurrent spironolactone was not allowed. Study 1 included patients with prior docetaxel chemotherapy. Specific efficacy results are not reported in the label.

Do not use in patients with baseline severe hepatic impairment (Child-Pugh Class C). Monitor liver function tests. Discontinue if severe hepatotoxicity occurs. Avoid strong CYP3A4 inducers unless necessary.

Abiraterone acetate is indicated for metastatic CRPC in combination with methylprednisolone. It is a treatment option for patients who have progressed on androgen deprivation therapy.