- Active ingredient
- abiraterone acetate
- Strength
- 250mg
- Form
- tablet
- Manufacturer
- hikma specialized pharmaceuticals
- Route
- oral.solid
Uses
Indicated in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer (CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC).
Do not use if
No absolute contraindications are listed in the FDA label. Use with caution in patients with severe hepatic impairment. Not approved for use in women.
Side effects
Common adverse effects include hypokalemia, fluid retention, hypertension, and cardiovascular complications due to mineralocorticoid excess. Adrenocortical insufficiency, hepatotoxicity, and increased fracture risk have also been reported.
Warnings
Closely monitor patients with cardiovascular disease for mineralocorticoid excess effects. Control hypertension and correct hypokalemia before and during treatment. Monitor liver function tests monthly for the first year. Risk of adrenocortical insufficiency increases under stress or during prednisone dose reduction.
How it works
Abiraterone acetate is converted in vivo to abiraterone, which inhibits CYP17 (17α-hydroxylase/C17,20-lyase). This enzyme is required for androgen biosynthesis in testicular, adrenal, and prostatic tumor tissues, thereby reducing testosterone and other androgen levels.
Storage
Store at controlled room temperature (20°C–25°C). Protect from moisture. Keep in the original container.
