ABIRATERONE HEATON

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance: each film-coated tablet contains 500 mg of abiraterone acetate.
Excipients: each film-coated tablet contains 241 mg of lactose and 12 mg sodium.

PHARMACEUTICAL FORM

Film-coated tablet.

THERAPEUTIC INDICATIONS

Abiraterone is indicated wit 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),
• 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.

DISPENSING AND REIMBURSEMENT

Medicinal product is subjected to medical prescription. The medicinal product is covered by public health insurance.