It is a tablet containing 250 mg of abiraterone acetate.
Abiraterone acetate is a prodrug converted to abiraterone, which inhibits CYP17 and reduces androgen production.
Current U.S. labeling includes metastatic castration-resistant prostate cancer and metastatic high-risk castration-sensitive prostate cancer when used with prednisone.
Abiraterone is generally classified as hormonal or androgen-directed therapy rather than conventional cytotoxic chemotherapy.
It inhibits CYP17, reducing androgen synthesis.
CYP17 inhibition can produce mineralocorticoid excess. Corticosteroid therapy forms part of the labeled treatment regimen and helps manage this hormonal effect.
Current U.S. labeled regimens use 1,000 mg once daily.
Four 250 mg tablets contain a total of 1,000 mg of abiraterone acetate.
No. Current U.S. labeling requires administration on an empty stomach.
The cited U.S. label specifies no food for two hours before and one hour after the dose.
Tablets should be swallowed whole and should not be crushed or chewed.
Potential adverse effects include hypertension, hypokalemia, fluid retention, fatigue and laboratory abnormalities. The specific profile varies among studies and treatment populations.
Yes. Hepatotoxicity can be serious, and liver-function monitoring is part of safe treatment.
Yes. Hypertension is a recognized consequence of mineralocorticoid excess.
Yes. Hypokalemia is a recognized adverse effect.
Zytiga is a reference medicine containing abiraterone acetate.
Authorized generics contain the same active substance and must meet applicable regulatory requirements. EMA-authorized generic examples have demonstrated bioequivalence to Zytiga. Product-specific excipients, packaging and manufacturer can differ.
The development history began with androgen-synthesis research at the Institute of Cancer Research and later involved Cougar Biotechnology.
Yes. Blood pressure, potassium, fluid retention and liver function are important monitoring considerations.
Yes. Abiraterone can interact with CYP3A4-inducing medicines and can affect exposure to certain CYP2D6 substrates.
The cited U.S. labeling does not recommend combining abiraterone acetate plus prednisone/prednisolone with radium Ra 223 dichloride because of increased fracture and mortality findings.
Abiraterone can harm a developing fetus. Pregnancy-related precautions in the applicable prescribing information should be followed.
Current U.S. labeling specifies concurrent GnRH analog therapy or prior bilateral orchiectomy.