Bicalutamide

DEA Class; Rx

Common Brand Names; Casodex

Oral nonsteroidal antiandrogen
Used for the treatment of metastatic prostatic carcinoma
Can cause hepatotoxicity; monitor liver function tests

Hypersensitivity

Female patients (esp pregnant-may harm fetus)

• 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%)
• 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%)

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

Antiandrogen therapy may cause morphological changes in spermatozoa; based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after administering final dose administered

Based on animal studies, therapy can lead to inhibition of spermatogenesis and may impair fertility in males of reproductive potential; long-term effects on male fertility not studied

Contraindicated for use in pregnant women because it can cause fetal harm; not indicated for use in females; there are no human data on use in pregnant women

Not indicated for use in pregnant women