Abirateronedosage

Metastatic castration-resistant prostate cancer:

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

ABIRTEGA 1,000 mg orally once daily with prednisone 5 mg orally once daily. Patients receiving ABIRTEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ABIRTEGA tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking ABIRTEGA. The tablets must be swallowed whole with water. Do not crush or chew tablets. Dose Modification:

For patients with baseline moderate hepatic impairment (Child-Pugh Class B), reduce the ABIRTEGA starting dose to 250 mg once daily.

For patients who develop hepatotoxicity during treatment, hold ABIRTEGA until recovery. Retreatment may be initiated at a reduced dose. ABIRTEGA should be discontinued if patients develop severe hepatotoxicity.

2.1 Recommended

Dose for Metastatic CRPC The recommended dose of ABIRTEGA is 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg orally twice daily.

2.2 Recommended

Dose for Metastatic High-risk CSPC The recommended dose of ABIRTEGA is 1,000 mg (four 250 mg tablets) orally once daily with prednisone 5 mg administered orally once daily.

2.3 Important

Administration Instructions Patients receiving ABIRTEGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ABIRTEGA tablets must be taken as a single dose once daily on an empty stomach. Do not eat food 2 hours before and 1 hour after taking ABIRTEGA. The tablets must be swallowed whole with water. Do not crush or chew tablets.

2.4 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 ABIRTEGA 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 5 x upper limit of normal (ULN) or total bilirubin greater than 3 x ULN occur in patients with baseline moderate hepatic impairment, discontinue ABIRTEGA and do not re-treat patients with ABIRTEGA. Do not use ABIRTEGA in patients with baseline severe hepatic impairment (Child-Pugh Class C). Hepatotoxicity For patients who develop hepatotoxicity during treatment with ABIRTEGA (ALT and/or AST greater than 5 x ULN or total bilirubin greater than 3 x ULN), interrupt treatment with ABIRTEGA. 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 2.5 x ULN and total bilirubin less than or equal to 1.5 x 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 2.5 x ULN and total bilirubin less than or equal to 1.5 x ULN. If hepatotoxicity recurs at the reduced dose of 500 mg once daily, discontinue treatment with ABIRTEGA. Permanently discontinue ABIRTEGA for patients who develop a concurrent elevation of ALT greater than 3 x ULN and total bilirubin greater than 2 x ULN in the absence of biliary obstruction or other causes responsible for the concurrent elevation.

2.5 Dose Modification

Guidelines for Strong CYP3A4 Inducers Avoid concomitant strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) during ABIRTEGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ABIRTEGA dosing frequency to twice a day only during the co-administration 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.