Abiraterone Krka is a cancer medicine used to treat men with metastatic prostate cancer. This is cancer that affects the prostate gland (a gland of the male reproductive system). It is used when the cancer has spread to other parts of the body (metastatic). Abiraterone Krka is used together with prednisone or prednisolone (anti-inflammatory medicines): - when the cancer is newly diagnosed, high risk and sensitive to hormones; Abiraterone Krka is then used in combination with a treatment called androgen deprivation therapy; - when medical castration (using medicines to stop the production of male hormones) with androgen deprivation therapy has not worked or no longer works in men who have either no symptoms or only mild symptoms of the disease, and who do not yet need chemotherapy (cancer medicines); - when medical or surgical castration and chemotherapy containing docetaxel have not worked or no longer work. Abiraterone Krka contains the active substance abiraterone acetate and is a ‘generic medicine’. This means that Abiraterone Krka contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Zytiga.
Therapeutic Indication
### Therapeutic indication Abiraterone Krka 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) (see section 5.1) - 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 (see section 5.1) - the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
Therapeutic Area (MeSH)
ATC Code
L02BX03
ATC Item
abiraterone
Pharmacotherapeutic Group
Endocrine therapy
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| abiraterone acetate | N/A | 阿比特龙 |
EMA Name
Abiraterone Krka
Medicine Name
Abiraterone Krka
Aliases
N/ANo risk management plan link.