Zytix 250 mg Tablet

Metastatic castration-resistant prostate cancer: Abiraterone 1,000 mg orally once daily with prednisone 5 mg orally twice daily.

Metastatic castration-sensitive prostate cancer: Abiraterone 1,000 mg orally once daily with prednisone 5 mg orally once daily.

Patients receiving Abiraterone should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone must be taken on an empty stomach with water at least 1 hour before or 2 hours after a meal. Do not crush or chew tablets.

Dose Modification:

• For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the Abiraterone starting dose to 250 mg once daily.
• For patients who develop hepatotoxicity during treatment, hold Abiraterone until recovery. Retreatment may be initiated at a reduced dose. Abiraterone should be discontinued if patients develop severe hepatotoxicity.