abiraterone 500 mg
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 )
florida pharmaceutical products, llc
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16 HOW SUPPLIED/STORAGE AND HANDLING
ABIRATERONE ACETATE Tablets, 500 mg are purple colored, oval shaped, biconvex bevel edged film-coated tablets, debossed with “A” one side and “500” on the other side. Bottles of 60 tablets with child-resistant closure NDC 71921-177-06 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range 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 tablets may harm a developing fetus. Women who are pregnant or women who may be pregnant should not handle
ABIRATERONE ACETATE tablets if broken, crushed, or damaged without protection, e.g., gloves [see Use in Specific Populations (8.1) ] .
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