Treatment of metastatic prostate carcinoma in conjunction with luteinizing hormone–releasing hormone (LHRH) analogues (goserelin, leuprolide).
PO (Adults): 50 mg once daily (must be given concurrently with LHRH analogue or following surgical castration).
Bicalutamide inhibits the action of androgens.
Women; pregnancy; hypersensitivity to the drug or any of the tablet components.
CV: Hot flashes (53%); hypertension (8%); angina pectoris, CHF, coronary artery disease, heart arrest, MI, syncope (2% to 5%).
CNS: Asthenia (22%); dizziness (10%); paresthesia (8%); headache, insomnia (7%); anxiety (5%); depression (4%); confusion, hypertonia, libido decreased, nervousness, neuropathy, somnolence (2% to 5%).
DERM: Rash (9%); sweating (6%); alopecia, dry skin, herpes zoster, pruritus, skin carcinoma, skin disorder (2% to 5%).
GI: Constipation (22%); nausea (15%); diarrhea (12%); abdominal pain (11%); dyspepsia, liver enzymes increased (7%); anorexia, flatulence, vomiting (6%); dry mouth, dysphagia, GI carcinoma, GI disorder, melena, periodontal abscess, rectal hemorrhage (2% to 5%).
GU: Hematuria, nocturia (12%); gynecomastia, UTI (9%); impotence (7%); breast pain, urinary frequency (6%); impaired urination, urinary retention (5%); urinary incontinence (4%); dysuria, hydronephrosis, urinary tract disorder, urinary urgency (2% to 5%).
M/N: Peripheral edema (13%); weight loss (7%); hyperglycemia (6%); alkaline phosphatase increased, weight gain (5%); BUN increased, creatinine increased, dehydration, edema, gout, hypercholesterolemia (2% to 5%).
MUSC: Back pain (25%); bone pain (9%); myasthenia (7%); arthritis (5%); pathological fracture (4%); leg cramps, myalgia (2% to 5%).
RESP: Dyspnea (13%); cough increased, pharyngitis (8%); bronchitis (6%); pneumonia, rhinitis (4%); asthma, epistaxis, lung disorder, sinusitis (2% to 5%); interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis (postmarketing).
OTHER: General pain (35%); pelvic pain (21%); infection (18%); anemia (11%); chest pain (8%); flu syndrome (7%); cataract specified, chills, cyst, fever, hernia, neck pain, neoplasm, sepsis (2% to 5%).
CYP3A4 substrates (eg, midazolam)
Mean midazolam Cmax increased 1.5-fold and AUC increased 1.9-fold when given with bicalutamide. Use caution when coadministered with CYP3A4 substrates.
PT may increase when bicalutamide is initiated in patients stabilized on long-term warfarin therapy.
Therapeutic Classification: antineoplastics
Pharmacologic Classification: antiandrogens
Absorption: Well absorbed after oral administration.
Protein Binding: 96%.
Metabolism/Excretion: Mostly metabolized by the liver.
Half-life: 5.8 days.
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