No

Androgen

In combination therapy with LHRH agonist analogues in treatment of advanced prostatic carcinoma

X

Known hypersensitivity to drug or any components of the product; pregnancy

>10%: Endocrine & metabolic: Hot flashes (49%)

greater than or equal to 2% to <5%:

Cardiovascular: Angina pectoris, congestive heart failure, edema

Central nervous system: Anxiety, depression, confusion, somnolence, nervousness, fever, chills

Dermatologic: Dry skin, pruritus, alopecia

Endocrine & metabolic: Breast pain, diabetes mellitus, decreased libido, dehydration, gout

Gastrointestinal: Anorexia, dyspepsia, rectal hemorrhage, xerostomia, melena, weight gain

Genitourinary: Polyuria, urinary impairment, dysuria, urinary retention, urinary urgency

Hepatic: Alkaline phosphatase increased

Neuromuscular & skeletal: Myasthenia, arthritis, myalgia, leg cramps, pathological fracture, neck pain, hypertonia, neuropathy

Renal: Creatinine increased

Respiratory: Cough increased, pharyngitis, bronchitis, pneumonia, rhinitis, lung disorder

Miscellaneous: Sepsis, neoplasma

<1%: Diarrhea (0.5%)

Symptoms of overdose include hypoactivity, ataxia, anorexia, vomiting, slow respiration, lacrimation

Treatment is supportive, dialysis not of benefit; induce vomiting

In vitro displacement of warfarin by bicalutamide

Store at room temperature

Pure nonsteroidal antiandrogen that binds to androgen receptors; specifically a competitive inhibitor for the binding of dihydrotestosterone and testosterone; prevents testosterone stimulation of cell growth in prostate cancer

Absorption: Rapid and complete

Protein binding: 96%

Metabolism: Extensive; stereospecific metabolism

Half-life: Up to 10 days; active enantiomer is 5.8 days

Elimination: Not yet studied

Adults: Oral: 1 tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide be taken at the same time each day; start treatment with bicalutamide at the same time as treatment with an LHRH analog.

Dosage adjustment in liver impairment: Limited data in subjects with severe hepatic impairment suggest that excretion of bicalutamide may be delayed and could lead to further accumulation. Use with caution in patients with moderate to severe hepatic impairment.

May be administered with or without food

Serum prostate-specific antigen, alkaline phosphatase, acid phosphatase, or prostatic acid phosphatase; prostate gland dimensions; skeletal survey; liver scans; chest x-rays; physical exam every 3 months; bone scan every 3-6 months; CBC, LFTs, EKG, echocardiograms, and serum testosterone and luteinizing hormone (periodically)

May produce anxiety, depression, and confusion

None reported

No information available to require special precautions

No effects or complications reported

Take as directed and do not alter dose or discontinue without consulting prescriber. Take at the same time each day with or without food. Void before taking medication. Diabetics should monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. You may lose your hair and experience impotency. May cause dizziness, confusion, or drowsiness (use caution when driving or engaging in tasks that require alertness until response to drug is known); nausea or vomiting (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or constipation (increased dietary fiber, fruit, or fluid and increased exercise may help). Report easy bruising or bleeding; yellowing of skin or eyes; change in color of urine or stool; unresolved changes in CNS (nervousness, chills, insomnia, somnolence); skin rash, redness, or irritation; chest pain or palpitations; difficulty breathing; urinary retention or inability to void; muscle weakness, tremors, or pain; persistent nausea, vomiting, diarrhea, or constipation; or other unusual signs or adverse reactions. Pregnancy precautions/breast-feeding: This drug will cause fetal abnormalities - use barrier contraceptives. Inform prescriber if breast-feeding.

Administer at the same time as treatment with LHRH analog

Tablet: 50 mg

Blackledge GR, Cockshott ID, and Furr BJ, "Casodex (Bicalutamide): Overview of a New Antiandrogen Developed for the Treatment of Prostate Cancer," Eur Urol, 1997, 31(Suppl 2):30-9.

Kennealey GT and Furr BJ, "Use of the Nonsteroidal Antiandrogen Casodex in Advanced Prostatic Carcinoma," Urol Clin North Am, 1991, 18(1):99-110.

Kolvenbag GJ and Blackledge GR, "Worldwide Activity and Safety of Bicalutamide: A Summary Review," Urology, 1996, 47(1A Suppl):70-9.

Kolvenbag GJ, Blackledge GR, and Gotting-Smith K, "Bicalutamide (Casodex) in the Treatment of Prostate Cancer: History of Clinical Development," Prostate, 1998, 34(1):61-72.

Tyrrell CJ, "Casodex: A Pure Nonsteroidal Antiandrogen Used as Monotherapy in Advanced Prostate Cancer," Prostate Suppl, 1992, 4:97-104.