XTANDI (enzalutamide)

XTANDI (enzalutamide)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• Castration-resistant prostate cancer (CRPC)

Patients must meet the following criteria for the indication(s) above:

• Must have castration resistant prostate cancer (progression after either GnRH therapy or bilateral orchiectomy)
• In those who have not had bilateral orchiectomy: Xtandi® will be used concomitantly with a GnRH analog

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P&T Committee:

• All non-FDA approved uses not listed in the approved indications
• Drug is not indicated for use in women

Dosing:

• 160 mg orally once daily
• Avoid co-administration with a strong CYP2C8 inhibitor
  • If strong CYP2C8 inhibitor cannot be avoided reduce dose to 80 mg PO daily

Warnings:

• Enzalutamide is a strong enzyme inducer, CYP3A4, CYP2C9, CYP2C19. Will reduce plasma concentrations of drug such as warfarin and omeprazole.
• Seizure risk is 0.5% in clinical trials

Approval:

6 months