Guidelines for Use
Approval requires a diagnosis of metastatic castration-resistant prostate cancer (CRPC) or metastatic high-risk castration-sensitive prostate cancer (CSPC). In addition, the requested medication must be used in combination with prednisone.
Rationale
To ensure appropriate use of Zytiga consistent with FDA approved indication.
Indications for Use
Zytiga is indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer CRPC) and metastatic high-risk castration-sensitive prostate cancer (CSPC).
Dosage and Administration
Metastatic castration-resistant prostate cancer: The recommended dose of Zytiga is 1,000 mg (two 500 mg tablets or four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily.
Metastatic high-risk castration-sensitive prostate cancer: The recommended dose of Zytiga is 1,000 mg (two 500 mg tablets or four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally once daily.
Patients receiving ZYTIGA should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. ZYTIGA must be taken on an empty stomach, either one hour before or two hours after a meal [see Clinical Pharmacology (12.3)]. The tablets should be swallowed whole with water. Do not crush or chew tab.
If a strong CYP3A4 inducer must be co-administered, increase the Zytiga dosing frequency to twice a day only during the co-administration period (e.g., from 1,000 mg once daily to 1,000 mg twice a day).