Abiraterone

Abiraterone is indicated with prednisone or prednisolone for:

• the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
• the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

Abiraterone is indicated with prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).

There are no data on the clinical safety and efficacy of multiple doses of abiraterone acetate when administered to patients with moderate or severe hepatic impairment (Child-Pugh Class B or C). Abiraterone should not be used in patients with severe hepatic impairment.

Abiraterone is not for use in women and is contraindicated in women who are or may potentially be pregnant.

Abiraterone with prednisone or prednisolone is contraindicated in combination with Ra-223.