Take XTANDI 160 mg administered orally once daily with or without food. • Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. ( 2.1 , 5.7 ) • Patients receiving XTANDI for castration-resistant prostate cancer, or metastatic castration sensitive prostate cancer should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy. • Patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis may be treated with or without a GnRH analog. 2.1 Recommended Dosage The recommended dosage of XTANDI is 160 mg administered orally once daily with or without food until disease progression or unacceptable toxicity. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Do NOT chew, dissolve, or open the capsules. Do NOT cut, crush, or chew the tablets.
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