Dosing and uses of Nilandron (nilutamide)
Adult dosage forms and strengths
tablet
- 150mg
Prostate Cancer
300 mg PO qDay for 30 days, THEn
150 mg PO qDay
Begin treatment on same day as or day after surgical castration
Monitor
Chest X-ray, pulmonary function tests, LFTs before starting
Pediatric dosage forms and strengths
Safety and efficacy not established
Nilandron (nilutamide) adverse (side) effects
>10%
Hot flushes (28%)
Testicular atrophy (16%)
Altered adaptation to dark (13%)
Dyspnea (11%)
Heachache (undefined)
Insomnia (undefined)
1-10%
Abdominal pain (10%)
Nausea (10%)
Constipation
Diarrhea
Aplastic anemia
Leukopenia
Alcohol intolerance
Angina, heart failure
HTn
Syncope
Dizziness
Malaise
Elevated LFTs
Gynecomastia
Impaired vision
Interstitial pneumonitis
UTI
Warnings
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
Contraindications
Hypersensitivity; severe hepatic, and/or respiratory impairment
Cautions
Hepatic Impairment
Hepatitis reported
Delay in vision adaptation to dark
Pregnancy and lactation
Pregnancy category: C
Lactation: N/A
Pregnancy categories
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.
Pharmacology of Nilandron (nilutamide)
Mechanism of action
Nonsteroidal antiandrogen, competitively binds androgen receptors and inhibits testosterone stimulation of cell growth in prostate cancer
Pharmacokinetics
Half-Life: 41-49 hr
Protein Bound: 84%
Metabolism: Liver
Excretion: urine (62%); feces (4%)
