Birato 250 Dosage/Direction for Use

Recommended Dose: Recommended Dose For Metastatic CRPC: The recommended dose of abiraterone acetate tablets is 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.
For Metastatic HSPC: The recommended dose of abiraterone acetate tablets is 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg orally once daily.
Important Administration Instructions: Patients receiving abiraterone acetate tablets should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. Abiraterone acetate tablets must be taken on an empty stomach, either one hour before or two hours after a meal [see Pharmacology: Pharmacokinetics under Actions]. The tablets should be swallowed whole with water. Do not crush or chew tablets.
Dose Modification Guidelines in Hepatic Impairment and Hepatotoxicity: Hepatic Impairment: In patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the recommended dose of abiraterone acetate tablets to 250 mg once daily. In patients with moderate hepatic impairment monitor ALT, 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 tablets and do not re-treat patients with abiraterone acetate tablets [see Patients with Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].
Do not use abiraterone acetate tablets in patients with baseline severe hepatic impairment (Child- Pugh Class C).
Hepatotoxicity: For patients who develop hepatotoxicity during treatment with abiraterone acetate tablets (ALT and/or AST greater than 5X ULN or total bilirubin greater than 3X ULN), interrupt treatment with abiraterone acetate tablets [see Hepatotoxicity under Precautions]. Treatment may be restarted at a reduced dose of 750 mg once daily following return of liver function tests to the patient's baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN. For patients who resume treatment monitor, serum transaminases and bilirubin at a minimum of every two weeks for three months and monthly thereafter.
If hepatotoxicity recurs at the dose of 750 mg once daily, re-treatment may be restarted at a reduced dose of 500 mg once daily following return of liver function tests to the patient's baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN.
If hepatotoxicity recurs at the reduced dose of 500 mg once daily, discontinue treatment with abiraterone acetate tablets.
Permanently discontinue abiraterone acetate tablets for patients who develop a concurrent elevation of ALT greater than 3x ULN and total bilirubin greater than 2x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation [see Hepatoxicity under Precautions].
Dose Modification Guidelines for Strong CYP3A4 Inducers: Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during abiraterone acetate tablet treatment.
If a strong CYP3A4 inducer must be coadministered, increase the abiraterone acetate tablets dosing frequency to twice a day only during the coadministration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day). Reduce the dose back to the previous dose and frequency, if the concomitant strong CYP3A4 inducer is discontinued [see Drugs that Inhibit or Induce CYP3A4 under Interactions and Pharmacology: Pharmacokinetics under Actions].
Mode of Administration: Oral use.