"The U.S. Food and Drug Administration today approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for"...
Metastatic Prostate Cancer
NILANDRON (nilutamide) tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D2).
For maximum benefit, NILANDRON (nilutamide) treatment must begin on the same day as or on the day after surgical castration.
DOSAGE AND ADMINISTRATION
The recommended dosage is 300 mg once a day for 30 days, followed thereafter by 150 mg once a day. NILANDRON (nilutamide) tablets can be taken with or without food.
NILANDRON (nilutamide) 150 mg tablets are supplied in boxes of 30 tablets. Each box contains 3 child-resistant, PVC, aluminum foil-backed blisters of 10 tablets (NDC 0088-1111-14). Each white, biconvex, cylindrical (10 mm in diameter) tablet has a triangular logo on one side and an internal reference number (168D) on the other.
Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.
Revised June 2006. Sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Country of Origin: France. FDA Rev date: 7/26/2004This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/14/2008
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