Classifications: antineoplastic; antiandrogen; Therapeutic: antineoplastic
Pregnancy Category: D
125 mg capsules
Nonsteroidal, nonhormonal, antiandrogenic drug that inhibits androgen uptake or binding of androgen to target tissues (i.e.,
prostatic cancer cells).
Interferes with the binding of both testosterone and dihydrotestosterone to target tissue (i.e., prostate cancer cells).
In combination with luteinizing hormone-releasing hormone agonists (i.e., leuprolide) or castration for early stage and metastatic
Hypersensitivity to flutamide; severe liver impairment if ALT is equal to twice the normal value; females; pregnancy (category
Route & Dosage
Adult: PO 250 mg (2 caps) q8h
- Use with caution in patients with severe hepatic impairment.
- Store at 2°30° C (36°86° F) in a tightly closed, light-resistant container.
Adverse Effects (≥1%)CNS:
Drowsiness, confusion, depression
, anxiety, nervousness. GI: Diarrhea
, nausea, vomiting, anorexia, hepatitis
, cholestatic jaundice
, encephalopathy, hepatic
necrosis, acute hepatic failure
, may increase ALT, AST, bilirubin
. Urogenital: Hot flashes, loss of libido, impotence
. Hematologic: Anemia
Rash. Body as a Whole:
may increase INR in patients on warfarin.
Readily absorbed from GI tract. Onset:
Antiandrogenic activity 2.2 h; symptomatic relief 24 wk. Duration:
3 mo2.5 y, with an average of 10.5 mo. Metabolism:
Metabolized in liver to at least 10 different metabolites; the major metabolite
, 2-hydroxyflutamide (SCH-16423), is an alpha-hydroxylated
derivative that is biologically active. Elimination:
98% in urine. Half-Life:
Assessment & Drug Effects
- Monitor therapeutic response with acid and alkaline phosphatase tests, bone and liver scans, chest x-ray, and physical exam.
- Monitor for symptomatic relief of bone pain.
- Assess for development of gynecomastia and galactorrhea; if these become bothersome, dosage reduction may be warranted.
- Lab tests: Monitor liver function and serum bilirubin periodically.
- Monitor for and report development of a lupus-like syndrome.
Patient & Family Education
- Be aware of potential adverse effects of therapy.
- Notify physician immediately of the following: Pain in upper abdomen, yellowing of skin and eyes, dark urine, respiratory
problems, rashes on face, difficulty urinating, sore throat, fever, chills.