Abiraxen

Adults:

Recommended Dose for Metastatic CRPC: The recommended dose of Abiraterone Acetate is 1,000 mg (two 500 mg tablets or four 250 mg tablets) taken by mouth once daily along with Prednisone 5 mg taken by mouth twice daily. Recommended Dose for Metastatic High Risk CSPC: The recommended dose of Abiraterone Acetate is 1,000 mg (two 500 mg tablets or four 250 mg tablets) taken by mouth once daily along with Prednisone 5 mg taken by mouth once daily. Patients receiving Abiraterone Acetate should also receive a gonadotropin releasing hormone (GnRH) analog at the same time or should have had bilateral orchiectomy. Abiraterone Acetate must be taken on an empty stomach, at least one hour before or at least two hours after a meal. The tablets should be swallowed whole with water. Do not crush or chew the tablets. Dose Modification: For patients with baseline moderate hepatic impairment (Child Pugh Class B), the Abiraterone Acetate starting dose should be reduced to 250 mg once daily. For patients who develop hepatotoxicity during treatment, Abiraterone Acetate should be held until recovery, and retreatment may then be started at a reduced dose. Abiraterone Acetate should be discontinued if patients develop severe hepatotoxicity. Concomitant use of strong CYP3A4 inducers, such as Phenytoin, Carbamazepine, Rifampin, Rifabutin, Rifapentine, and Phenobarbital, should be avoided during Abiraterone Acetate treatment. If a strong CYP3A4 inducer must be given at the same time, the Abiraterone Acetate dosing frequency should be increased to twice a day only during the period of co administration, for example, from 1,000 mg once daily to 1,000 mg twice a day. Once the concomitant strong CYP3A4 inducer is stopped, the dose should be reduced back to the previous dose and frequency. Or, as directed by the registered physician. Pediatric Use: The safety and effectiveness of Abiraterone Acetate in pediatric patients have not been established.