Generic Name and Formulations:
Nilutamide 150mg; tabs.
Covis Pharmaceuticals, Inc.
Indications for NILANDRON:
Metastatic prostate cancer (Stage D2), as an adjunct to surgical castration.
300mg once daily for 30 days then 150mg once daily, starting day of or day after surgical castration.
Severe hepatic impairment or respiratory insufficiency.
Obtain baseline liver and pulmonary function tests and chest X-ray. Monitor for interstitial pneumonitis; discontinue if occurs. Monitor liver function for first 4 months then periodically; discontinue if ALT > 2xULN or jaundice occurs. May discolor urine or sclera. Pregnancy (Cat.C): not for use in women. Nursing mothers.
Monitor drugs metabolized by CYP450 (eg, Vit. K antagonists, theophylline, phenytoin); may need to adjust dose. May cause alcohol intolerance.
Hot flushes, impaired night vision, GI upset, increased liver enzymes, constipation, dizziness, abnormal vision, hypertension, hepatitis, interstitial pneumonitis.
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