Dosing and uses of Casodex (bicalutamide)
Adult dosage forms and strengths
tablet
- 50mg
Prostate Cancer
50 mg PO qDay
Use in combination with LHRH analog
Locally Advanced Prostate Cancer
150 mg PO qDay as monotherapy
Monitor
LFTs at baseline, regular intervals for 4 months, then periodically
Pediatric dosage forms and strengths
Safety and efficacy not established
Casodex (bicalutamide) adverse (side) effects
>10%
Hot flashes (53%)
General pain (35%)
Back pain (25%)
Asthenia (22%)
Constipation (22%)
Pelvic pain (21%)
Infection (18%)
Nausea (15%)
Dyspnea (13%)
Edema (13%)
Peripheral edema (13%)
Diarrhea (12%)
Hematuria (12%)
Nocturia (12%)
Abdominal pain (11%)
Anemia (11%)
1-10%
Gynecomastia (9%)
Rash (9%)
UTI (9%)
Chest pain (8%)
Hypertension (8%)
Vomiting (8%)
Flu like symptoms (7%)
Headache (7%)
LFTs elevation (7%)
Weight loss (7%)
Anorexia (6%)
Breast pain (6%)
Anxiety (5%)
Arthritis (5%)
Postmarketing reports
Photosensitivity
Interstitial lung disease including interstitial pneumonitis and pulmonary fibrosis
Warnings
Contraindications
Hypersensitivity
Female patients (esp pregnant-may harm fetus)
Cautions
Hepatic impairment
Severe liver injury resulting in hospitalization or death reported
Spermatogenesi inhibition reported
Gynecomastia and breast pain reported during therapy when used as single agent
May reduce glucose tolerance in males when used in combination with LHRH; monitor blood glucose
Monitor prostate specific antigen (PSA) progression if PSA increases
Pregnancy and lactation
Pregnancy category: X
Lactation: Bicalutamide is not indicated for use in women.
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 Casodex (bicalutamide)
Mechanism of action
Nonsteroidal antiandrogen, competitively binds androgen receptors and inhibits testosterone stimulation of cell growth in prostate cancer
Pharmacokinetics
Half-Life: 5.8 d
Peak plasma time: 31 hr
Peak plasma concentration: 0.77 mcg/mL
Protein Bound: 96%
Metabolism: Liver
Clearance: 0.32 L/hr
Excretion: Urine (36%), feces (42%)
Dialyzable: No
