Casodex

SIDE EFFECTS

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 (³5% In Either Treatment Group) Regardless of Causality

Body System / Adverse Event	Treatment Group Number of Patients (%)
	Treatment Group Number of Patients (%)
	CASODEX Plus LHRH Analogue	Flutamide Plus LHRH Analogue
	(n= 401)	(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 Test ^†	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
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	22 (5)	24 (6)
Increased Weight Gain	22 (5)	18 (4)
Musculoskeletal
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)
Urination Impaired	19 (5)	15 (4)
Urinary Incontinence	15 (4)	32 (8)

† Increased liver enzyme test includes increases in AST, ALT or both.

‡ Anemia includes anemia, hypochromic-and iron deficiency anemia

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.

DRUG INTERACTIONS

In vitro studies have shown CASODEX can displace coumarin anticoagulants, such as warfarin, from their protein-binding sites. It is recommended that if CASODEX is started in patients already receiving coumarin anticoagulants, prothrombin times should be closely monitored and adjustment of the anticoagulant dose may be necessary (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions).

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