A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Casodex Side Effects, and Drug Interactions - Bicalutamide
Casodex Side Effects, and Drug Interactions - Bicalutamide
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 (%) |
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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