Classifications: antineoplastic agent; antiandrogen; Therapeutic: antineoplastic; antiandrogen
Pregnancy Category: C
150 mg tablets
Nonsteroidal with antiandrogen activity. Blocks the effects of testosterone at the androgen receptor sites, thus preventing
the normal androgenic response.
Effective in blocking testosterone in treatment of metastatic prostate carcinoma.
Use with surgical castration for metastatic prostate cancer.
Severe hepatic impairment; severe respiratory insufficiency; hypersensitivity to nilutamide; pregnancy (category C), lactation.
Asian patients relative to causing interstitial pneumonitis; alcoholics. Safety and effectiveness in children are not established.
Route & Dosage
|Metastatic Prostate Cancer
Adult: PO 300 mg q.d. x 30 d, then 150 mg q.d.
- Give first dose on the day of or day after surgical castration.
- Store below 15°30° C (59°86° F) and protect from light.
Adverse Effects (≥1%)Body as a Whole: Hot flushes, impotence, decreased libido, malaise,
edema, weight loss, arthritis
Nervousness, paresthesias. CV:
Angina, heart failure, syncope. GI: Diarrhea
, GI hemorrhage, melena, dry mouth. Respiratory:
lung disease, rhinitis. Skin:
Pruritus. Other: Alcohol
intolerance. Special Senses:
InteractionsDrug: Carbamazepine, rifampin, phenytoin
may decrease level; fluconazole, gemfibrozil, omeprazole
may increase levels. Herbal: St. John's wort
may decrease levels.
Rapidly from GI tract. Metabolism:
In the liver (CYP2C19). Elimination:
In urine. Half-Life:
Assessment & Drug Effects
- Obtain baseline chest x-ray before treatment and periodically thereafter.
- Closely monitor for S&S of pneumonitis; at the first sign of adverse pulmonary effects, withhold drug and notify physician.
Abnormal ABGs may indicate need to discontinue drug.
- Lab tests: Monitor liver function before beginning treatment and at 3-mo intervals; if serum transaminases increase >23
times upper limit of normal, discontinue treatment.
- Monitor patients taking phenytoin, theophylline, or warfarin closely for toxic levels of these drugs.
Patient & Family Education
- Report following S&S of adverse effects on lungs to physician immediately: Development of chest pain, dyspnea, and cough
- Report S&S of liver injury to physician: Jaundice, dark urine, fatigue, or signs of GI distress including nausea, vomiting,
- Use caution when moving from lighted to dark areas because the drug may slow visual adaptation to darkness. Tinted glasses
may partially alleviate the problem.