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Casodex

"The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications “ Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North Ameri"...

Casodex

Side Effects
Interactions

SIDE EFFECTS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

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

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

Table 1: Incidence of Adverse Reactions ( ≥ 5% in Either Treatment Group) Regardless of Causality

Body System
  Adverse Reaction
Treatment Group Number of Patients (%)
CASODEX Plus LHRH Analog
(n=401)
Flutamide Plus LHRH Analog
(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 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 reactions (greater than or equal to 2%, but less than 5%) reported in the CASODEX (bicalutamide) -LHRH analog 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 (bicalutamide) -LHRH analog treated and flutamide-LHRH analog treated patients.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of CASODEX (bicalutamide) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Uncommon cases of hypersensitivity reactions, including angioneurotic edema and urticaria [see CONTRAINDICATIONS], and uncommon cases of interstitial lung disease, including interstitial pneumonitis and pulmonary fibrosis, have been reported with CASODEX (bicalutamide) .

Reduction in glucose tolerance, manifesting as diabetes or a loss of glycemic control in those with pre-existing diabetes, has been reported during treatment with LHRH agonists.

Read the Casodex (bicalutamide) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Clinical studies have not shown any drug interactions between bicalutamide and LHRH analogs (goserelin or leuprolide). There is no evidence that bicalutamide induces hepatic enzymes.

In vitro studies have shown that R-bicalutamide is an inhibitor of CYP 3A4 with lesser inhibitory effects on CYP 2C9, 2C19 and 2D6 activity. Clinical studies have shown that with co-administration of CASODEX (bicalutamide) , mean midazolam (a CYP 3A4 substrate) levels may be increased 1.5 fold (for Cmax) and 1.9 fold (for AUC). Hence, caution should be exercised when CASODEX (bicalutamide) is co-administered with CYP 3A4 substrates.

In vitro protein-binding studies have shown that bicalutamide can displace coumarin anticoagulants from binding sites. Prothrombin times should be closely monitored in patients already receiving coumarin anticoagulants who are started on CASODEX (bicalutamide) and adjustment of the anticoagulant dose may be necessary.

Read the Casodex Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 3/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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Casodex - User Reviews

Casodex User Reviews

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