The following is a summary of current U.S. prescribing information and is not an individualized dosing recommendation.
| Treatment setting | Labeled abiraterone regimen |
|---|---|
| Metastatic CRPC | 1,000 mg once daily with prednisone 5 mg twice daily |
| Metastatic high-risk CSPC | 1,000 mg once daily with prednisone 5 mg once daily |
The 1,000 mg dose can be supplied as four 250 mg tablets or two 500 mg tablets, depending on the product.
Administration
Abiraterone acetate must be taken once daily on an empty stomach. Do not eat for two hours before administration and for one hour afterward. Tablets should be swallowed whole with water and should not be crushed or chewed.
Hepatic impairment
For patients with baseline moderate hepatic impairment, current U.S. labeling specifies a reduced starting dose of 250 mg once daily. Abiraterone should not be used in patients with baseline severe hepatic impairment under the cited U.S. labeling.
Hepatotoxicity during treatment
If clinically significant hepatotoxicity develops, treatment may need to be interrupted and subsequently restarted at a reduced dose when appropriate. Severe hepatotoxicity can require permanent discontinuation.
Renal impairment
No clinically meaningful increase in abiraterone exposure was observed in the cited pharmacokinetic study involving patients with end-stage renal disease on dialysis after a single dose. Treatment decisions nevertheless require review of the complete prescribing information and the patient’s clinical condition.
Important limitation
Dosing can differ by jurisdiction, formulation and treatment setting. The prescribing information applicable to the patient’s product and country takes priority.