Each tablet contains:
Abiraterone Acetate …….. 250 mg
Mechanism of Action
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17alpha-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal and prostatic tumour tissues and is required for androgen biosynthesis.
Cytochrome (CY) P17 catalyses two sequential reactions: 1) the conversion of pregnenolone and progesterone to their 17alpha-hydroxy derivatives by 17alpha-hydroxylase activity and, 2) the subsequent formation of dehydroepiandrosterone (DHEA) and androstenedione, respectively by C17,20 lyase activity. DHEA and androstenedione are androgens and are precursors of testosterone. Inhibition of CYP17 by abiraterone can also result in increased mineralocorticoid production by the adrenals.
Zecyte Tablets manufactured by Cipla Pharma India contains Abiraterone Acetate as active ingredient in it. Abiraterone is a type of hormone therapy. It is also called abiraterone acetate, CB7630 or Zytiga. Abiraterone acetate is indicated for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer.
In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of abiraterone acetate to 250 mg once daily. A once daily dose of 250 mg in patients with moderate hepatic impairment is predicted to result in an AUC similar to the AUC seen in patients with normal hepatic function receiving 1,000 mg once daily. However, there are no clinical data at the dose of 250 mg once daily in patients with moderate hepatic impairment and caution is advised. In patients with moderate hepatic impairment monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. If elevations in ALT and/or AST greater than 5X upper limit of normal (ULN) or total bilirubin greater than 3X ULN occur in patients with baseline moderate hepatic impairment, discontinue abiraterone acetate and do not re-treat patients with abiraterone acetate.
Avoid abiraterone acetate in patients with baseline severe hepatic impairment (Child-Pugh Class C), as abiraterone acetate has not been studied in this population, and no dose adjustment can be predicted.