Active ingredients: Abiraterone
Product Name and Form
ZYTIGA 250 mg tablets.
White to off-white oval tablets, debossed with AA250 on one side.
Qualitative and Quantitative Composition
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect: Each tablet contains 189 mg of lactose and 6.8 mg of sodium.
For the full list of excipients, see section 6.1.
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals.
Silica, colloidal anhydrous
Pack sizes and Marketing
Round white HDPE bottles fitted with a polypropylene child-resistant closure containing 120 tablets. Each pack contains one bottle.
Janssen-Cilag International NV
Date of first authorisation: 5 September 2011