abiraterone acetate 250 MG Oral Tablet
1 INDICATIONS AND USAGE Abiraterone acetate tablets are indicated in combination with prednisone for the treatment of patients with Metastatic castration-resistant prostate cancer (CRPC) Metastatic high-risk castration-sensitive prostate cancer (CSPC) Abiraterone acetate tablets are a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). ( 1 ) metastatic high-risk castration-sensitive prostate cancer (CSPC). ( 1 )
apotex corp.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ABIRATERONE ACETATE 250 mg tablets, USP are white to off-white, oval, biconvex uncoated tablets. Engraved "A250" on one side, "APO" on the other side.
ABIRATERONE ACETATE 250 mg tablets, USP are available in high-density polyethylene bottles of 120. Bottle of 120 tablets NDC Number 60505-4327-1 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Based on its mechanism of action,
ABIRATERONE ACETATE may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle
ABIRATERONE ACETATE 250 mg uncoated tablets or other
ABIRATERONE ACETATE tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations ( 8.1 )] .
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