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 )
mylan pharmaceuticals inc.
OVAL WHITE M AB500
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abiraterone acetate 250 MG Oral Tablet
Mylan Pharmaceuticals Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
ABIRATERONE ACETATE Tablets, USP are available containing 250 mg or 500 mg of
ABIRATERONE ACETATE, USP. 500 mg film-coated tablets: The 500 mg tablets are white, film-coated, oval, unscored tablets debossed with M on one side of the tablet and AB500 on the other side. They are available as follows: NDC 0378-6921-91 bottles of 60 tablets 250 mg uncoated tablets: The 250 mg tablets are white to off-white, oval, unscored tablets debossed with M on one side of the tablet and AB250 on the other side. They are available as follows: NDC 0378-6920-78 bottles of 120 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F); excursions permitted in the range from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 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 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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