This page summarizes important prescribing information. It is not a replacement for the complete official product label.
Indications
Current U.S. labeling identifies abiraterone acetate with prednisone for:
- Metastatic castration-resistant prostate cancer.
- Metastatic high-risk castration-sensitive prostate cancer.
Dosage
Current U.S. regimens are:
- mCRPC: 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.
Administration
Take once daily on an empty stomach. Do not eat for two hours before or one hour after the dose. Swallow tablets whole.
Contraindications
The cited current generic U.S. labeling lists no contraindications, while reproductive warnings and other major precautions remain applicable.
Major warnings
Important warnings and precautions include:
- Mineralocorticoid excess
- Hypertension
- Hypokalemia
- Fluid retention
- Cardiovascular adverse reactions
- Adrenocortical insufficiency
- Hepatotoxicity
- Drug interactions
- Fracture and mortality concerns with radium Ra 223 combination
Complete label
For prescribing decisions, clinicians should consult the current official label applicable to the exact product and jurisdiction.