Enzalutamide, sold under the brand name Xtandi, is a nonsteroidal antiandrogen medication. Enzalutamide is an androgen receptor inhibitor. The chemical name is 4-{3-[4-cyano-3-(trifluoromethyl)phenyl]-5,5- dimethyl-4-oxo-2-sulfanylideneimidazolidin-1-yl}-2-fluoro-N-methylbenzamide.
Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water.
XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
Xtandi (Enzalutamide) Indications:
XTANDI is FDA approved to treat two forms of advanced prostate cancer:
Prostate cancer that no longer responds to treatment that lowers testosterone and has not spread to other parts of the body. This is also known as non-metastatic castration-resistant prostate cancer (nmCRPC).
Prostate cancer that no longer responds to treatment that lowers testosterone and has spread to other parts of the body. This is also known as metastatic castration-resistant prostate cancer (mCRPC).