药物信息为CASODEX (bicalutamide) TABLETS (AstraZeneca Pharnaceuticals LP): ADVERSE REACTIONS

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  • In patients with advanced prostate cancer treated with CASODEX in combination with an LHRH analogue, the most frequent adverse experience was hot flashes (53%).

    In the multicenter, double-blind, controlled clinical trial comparing CASODEX 50 mg once daily with flutamide 250 mg three times a day, each in combination with an LHRH analogue, the following adverse experiences with an incidence of 5% or greater, regardless of causality, have been reported.

    Table 2 Incidence of Adverse Events (≥ 5% in Either Treatment Group) Regardless of Causality

    Body System

    Adverse Event

    Treatment Group

    Number of Patients (%)

    CASODEX Plus

    LHRH Analogue

    (n=401)

    Flutamide Plus

    LHRH Analogue

    (n=407)

    Body as a Whole

    Pain (General)

    142(35)

    127(31)

    Back Pain

    102(25)

    105(26)

    Asthenia

    89(22)

    87(21)

    Pelvic Pain

    85(21)

    70(17)

    Infection

    71(18)

    57(14)

    Abdominal Pain

    46(11)

    46(11)

    Chest Pain

    34(8)

    34(8)

    Headache

    29(7)

    27(7)

    Flu Syndrome

    28(7)

    30(7)

    Cardiovascular

    Hot Flashes

    211(53)

    217(53)

    Hypertension

    34(8)

    29(7)

    Digestive

    Constipation

    87(22)

    69(17)

    Nausea

    62(15)

    58(14)

    Diarrhea

    49(12)

    107(26)

    Increased Liver Enzyme TestIncreased liver enzyme test includes increases in AST, ALT or both.

    30(7)

    46(11)

    Dyspepsia

    30(7)

    23(6)

    Flatulence

    26(6)

    22(5)

    Anorexia

    25(6)

    29(7)

    Vomiting

    24(6)

    32(8)

    Hemic and Lymphatic

    AnemiaAnemia includes anemia, hypochronic- and iron deficiency anemia.

    45(11)

    53(13)

    Metabolic and

    Nutritional

    Peripheral Edema

    53(13)

    42(10)

    Weight Loss

    30(7)

    39(10)

    Hyperglycemia

    26(6)

    27(7)

    Alkaline Phosphatase Increased

    22(5)

    24(6)

    Weight Gain

    22(5)

    18(4)

    Muscoloskeletal

    Bone Pain

    37(9)

    43(11)

    Myasthenia

    27(7)

    19(5)

    Arthritis

    21(5)

    29(7)

    Pathological Fracture

    17(4)

    32(8)

    Nervous System

    Dizziness

    41(10)

    35(9)

    Paresthesia

    31(8)

    40(10)

    Insomnia

    27(7)

    39(10)

    Anxiety

    20(5)

    9(2)

    Depression

    16(4)

    33(8)

    Respiratory System

    Dyspnea

    51(13)

    32(8)

    Cough Increased

    33(8)

    24(6)

    Pharyngitis

    32(8)

    23(6)

    Bronchitis

    24(6)

    22(3)

    Pneumonia

    18(4)

    19(5)

    Rhinitis

    15(4)

    22(5)

    Skin and Appendages

    Rash

    35(9)

    30(7)

    Sweating

    25(6)

    20(5)

    Urogenital

    Nocturia

    49(12)

    55(14)

    Hematuria

    48(12)

    26(6)

    Urinary Tract Infection

    35(9)

    36(9)

    Gynecomastia

    36(9)

    30(7)

    Impotence

    27(7)

    35(9)

    Breast Pain

    23(6)

    15(4)

    Urinary Frequency

    23(6)

    29(7)

    Urinary

    Retention

    20(5)

    14(3)

    Urinary

    Impaired

    19(5)

    15(4)

    Urinary

    Incontinence

    15(4)

    32(8)

    Other adverse experiences (greater than or equal to 2%, but less than 5%) reported in the CASODEX-LHRH analogue treatment group are listed below by body system and are in order of decreasing frequency within each body system regardless of causality.

    Body as a Whole: Neoplasm; Neck pain; Fever; Chills; Sepsis; Hernia; Cyst

    Cardiovascular: Angina pectoris; Congestive heart failure; Myocardial infarct; Heart arrest; Coronary artery disorder; Syncope

    Digestive: Melena; Rectal hemorrhage; Dry mouth; Dysphagia; Gastrointestinal disorder; Periodontal abscess; Gastrointestinal carcinoma

    Metabolic and Nutritional: Edema; Bun increased; Creatinine increased; Dehydration; Gout; Hypercholesteremia

    Musculoskeletal: Myalgia; Leg cramps

    Nervous: Hypertonia; Confusion; Somnolence; Libido decreased; Neuropathy; Nervousness

    Respiratory: Lung disorder; Asthma; Epistaxis; Sinusitis

    Skin and Appendages: Dry skin; Alopecia; Pruritus; Herpes zoster; Skin carcinoma; Skin disorder

    Special Senses: Cataract specified

    Urogenital: Dysuria; Urinary urgency; Hydronephrosis; Urinary tract disorder

  • Abnormal Laboratory Test Values:

  • Laboratory abnormalities including elevated AST, ALT, bilirubin, BUN, and creatinine and decreased hemoglobin and white cell count have been reported in both CASODEX-LHRH analogue treated and flutamide-LHRH analogue treated patients.

  • Postmarketing Experience:

  • Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria, and uncommon cases of interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, have been reported with CASODEX.

  • Drug Information Provided by National Library of Medicine (NLM).
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