This page summarizes important prescribing concepts. It does not reproduce an official label and should not replace the latest regulatory document.
Indications
Current U.S. labeling includes abiraterone acetate with prednisone for:
- Metastatic castration-resistant prostate cancer.
- Metastatic high-risk castration-sensitive prostate cancer.
Dose
The current U.S. labeled dose is 1,000 mg once daily. Prednisone is administered at an indication-specific dose.
Administration
The medicine is taken once daily on an empty stomach. No food should be consumed for 2 hours before or 1 hour after administration, and tablets should be swallowed whole.
Androgen deprivation
A GnRH analog should be administered concurrently unless the patient has undergone bilateral orchiectomy.
Important warnings
Major safety issues include:
- Mineralocorticoid excess
- Hepatotoxicity
- Cardiovascular effects
- Hypokalemia
- Hypertension
- Fluid retention
- Adrenocortical insufficiency
- Drug interactions
- Embryo-fetal risk
Hepatic impairment
Baseline moderate hepatic impairment requires a reduced starting dose under current U.S. labeling. Hepatotoxicity during treatment can require interruption, dose reduction or discontinuation.
Complete label
The applicable current FDA, EMA or national prescribing information should be consulted for complete requirements, including detailed adverse-reaction frequencies, laboratory monitoring, interaction information and special-population instructions.