Bicatero

Metastatic prostate cancer in combination w/ LHRH analogue therapy or surgical castration.

Adult Metastatic prostate cancer 1 tab once daily. Treatment should be started concomitantly w/ LNRH analogue.

May be taken with or without food.

Hypersensitivity. Concomitant use w/ terfenadine, astemizole or cisapride. Women & childn.

Hypersensitivity reactions, including angioneurotic edema & urticaria. Discontinue treatment immediately if patient develops jaundice or ALT rises >2x ULN. Hepatitis or marked increases in liver enzymes lead to drug discontinuation. Gynecomastia & breast pain. Reduction in glucose tolerance; monitor blood glucose in patients receiving bicalutamide in combination w/ LHRH agonist. Measure serum transaminase levels prior to starting treatment, at regular intervals for the 1st 4 mth of treatment, & periodically thereafter; particularly serum ALT if clinical signs & symptoms suggestive of liver dysfunction occur. Moderate to severe hepatic impairment. Consider periodic LFT for hepatically impaired patients on long-term therapy.

Peripheral edema; pain; hot flashes, breast pain, gynecomastia; constipation, nausea, diarrhea, abdominal pain; pelvic pain, hematuria, nocturia; anemia; back pain, weakness; dyspnea; infection. Chest pain, HTN, angina pectoris, cardiac arrest, CHF, edema, MI, CAD, syncope; dizziness, headache, insomnia, anxiety, depression, chills, confusion, fever, nervousness, somnolence; rash, alopecia, dry skin, pruritus, skin carcinoma; hyperglycemia, dehydration, gout, hypercholesterolemia, decreased libido; dyspepsia, wt loss or gain, anorexia, flatulence, vomiting, dysphagia, GI carcinoma, melena, periodontal abscess, rectal hemorrhage, xerostomia; UTI, impotence, polyuria, urinary retention, impairment, incontinence & urgency, dysuria; increased LFTs & alkaline phosphatase; bone pain, paresthesia, myasthenia, arthritis, pathological fracture, hypertonia, leg cramps, myalgia, neck pain, neuropathy; cataract; increased BUN & creatinine, hydronephrosis; cough, pharyngitis, bronchitis, pneumonia, rhinitis, asthma, epistaxis, sinusitis; flu-like syndrome, diaphoresis, cyst, hernia, herpes zoster, sepsis.

Increase C_max & AUC of midazolam. Concomitant use w/ coumarin anticoagulants eg, warfarin (closely monitor prothrombin times & adjust anticoagulant dose).

Cancer Hormone Therapy

L02BB03 - bicalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

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