Brand and Other Names:Nilandron
- Classes: Antineoplastics, Antiandrogen
Dosing & Uses
Dosage Forms & Strengths
300 mg PO qDay for 30 days, THEN
150 mg PO qDay
Begin treatment on same day as or day after surgical castration
Chest X-ray, pulmonary function tests, LFTs before starting
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Hot flushes (28%)
Testicular atrophy (16%)
Altered adaptation to dark (13%)
Abdominal pain (10%)
Angina, heart failure
Black Box Warnings
Interstitial pneumonitis has been reported in 2% of patients exposed to nilutamide. Reports of interstitial changes including pulmonary fibrosis leading to hospitalization and death rarely reported in post marketing surveillance. Most cases were reversible with discontinuation and occurred within first 3 months of therapy
Hypersensitivity; severe hepatic, and/or respiratory impairment
Delay in vision adaptation to dark
Pregnancy & Lactation
Pregnancy Category: C
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Nonsteroidal antiandrogen, competitively binds androgen receptors and inhibits testosterone stimulation of cell growth in prostate cancer
Half-Life: 41-49 hr
Protein Bound: 84%
Excretion: urine (62%); feces (4%)
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