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Nilandron Generic Name & Formulations
Legal Class
Rx
General Description
Nilutamide 150mg; tabs.
Pharmacological Class
Antiandrogen.
How Supplied
Tabs—30
Manufacturer
Nilandron Indications
Indications
Metastatic prostate cancer (Stage D2), as an adjunct to surgical castration.
Nilandron Dosage and Administration
Adult
300mg once daily for 30 days then 150mg once daily, starting day of or day after surgical castration.
Children
Not applicable.
Nilandron Contraindications
Contraindications
Severe hepatic impairment or respiratory insufficiency.
Nilandron Boxed Warnings
Boxed Warning
Interstitial pneumonitis.
Nilandron Warnings/Precautions
Warnings/Precautions
Obtain baseline liver and pulmonary function tests, routine chest X-ray. Monitor for interstitial pneumonitis; discontinue if symptoms occur. Monitor liver function for first 4 months then periodically; discontinue if ALT > 2xULN or jaundice occurs. May discolor urine or sclera. Pregnancy (not for use in women). Nursing mothers.
Nilandron Pharmacokinetics
See Literature
Nilandron Interactions
Interactions
Monitor drugs metabolized by CYP450 (eg, Vit. K antagonists, theophylline, phenytoin); may need to adjust dose. May cause alcohol intolerance.
Nilandron Adverse Reactions
Adverse Reactions
Hot flushes, impaired night vision, GI upset, increased liver enzymes, constipation, dizziness, abnormal vision, hypertension, hepatitis, interstitial pneumonitis.
Nilandron Clinical Trials
See Literature
Nilandron Note
Not Applicable
Nilandron Patient Counseling
See Literature
