Basic Information
ABIRATERONE-AFT TABLET 250MG
TABLET
Regulatory Information
SIN16853P
September 5, 2023
Prescription Only
Therapeutic
ORAL
January 24, 2024
June 3, 2025
XL02BX03
Company Information
APEX PHARMA MARKETING PTE. LTD.
APEX PHARMA MARKETING PTE. LTD.
Active Ingredients
Strength: 250mg
Detailed Information
Contraindications
**CONTRAINDICATIONS** - Hypersensitivity to the active substance or to any of the excipients (see _**List of excipients**_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Women who are or may potentially be pregnant (see _**Pregnancy, Breast-feeding and Fertility – Pregnancy**_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - Severe hepatic impairment \[Child-Pugh Class C (see _**Dosage and Administration, Warnings and Precautions**_ and _**Pharmacokinetic properties**_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)\].
Indication Information
**Indications** ABIRATERONE-AFT TABLET 250 mg 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). - 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 _**Pharmacodynamic properties**_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.