Basic Information
BIRATO 250 ABIRATERONE ACETATE TABLET USP 250MG
TABLET
Regulatory Information
SIN16916P
December 18, 2023
Prescription Only
Therapeutic
ORAL
January 24, 2024
June 3, 2025
XL02BX03
Company Information
Active Ingredients
Strength: 250mg
Detailed Information
Contraindications
**Contraindications** - Hypersensitivity to the active substance or to any of the excipients listed in section 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 section Fertility, pregnancy and lactation – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Severe hepatic impairment \[Child-Pugh Class C (see sections Posology and method of administration, Special warnings and precautions for use and Pharmacokinetic properties – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_)\].
Indication Information
**Therapeutic indications** Abiraterone Acetate is indicated with prednisone or prednisolone for: - The treatment of metastatic castration resistant prostate cancer 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 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 in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.