CASODEX

CASODEX — bicalutamide tablet
Physicians Total Care, Inc.

1. INDICATIONS AND USAGE

CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate.

CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)].

2. DOSAGE AND ADMINISTRATION

The recommended dose for CASODEX therapy in combination with an LHRH analog is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that CASODEX be taken at the same time each day. Treatment with CASODEX should be started at the same time as treatment with an LHRH analog.

2.1. Dosage Adjustment in Renal Impairment

No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)].

2.2. Dosage Adjustment in Hepatic Impairment

No dosage adjustment is necessary for patients with mild to moderate hepatic impairment. In patients with severe liver impairment (n=4), although there was a 76% increase in the half-life (5.9 and 10.4 days for normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment is necessary [see Use in Specific Populations (8.6)].

3. DOSAGE FORMS & STRENGTHS

CASODEX® (bicalutamide) 50 mg Tablets for oral administration.

4. CONTRAINDICATIONS

4.1. Hypersensitivity

CASODEX is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet’s components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported [see Adverse Reactions (6.2)].

4.2. Women

CASODEX has no indication for women, and should not be used in this population.

4.3. Pregnancy

CASODEX may cause fetal harm when administered to a pregnant woman. CASODEX is contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using CASODEX. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be appraised of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

5. WARNINGS AND PRECAUTIONS

5.1. Hepatitis

Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported post-marketing in association with the use of CASODEX. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of CASODEX patients in controlled clinical trials.

Serum transaminase levels should be measured prior to starting treatment with CASODEX, at regular intervals for the first four months of treatment, and periodically thereafter. If clinical symptoms or signs suggestive of liver dysfunction occur (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, “flu-like” symptoms, dark urine, jaundice, or right upper quadrant tenderness), the serum transaminases, in particular the serum ALT, should be measured immediately. If at any time a patient has jaundice, or their ALT rises above two times the upper limit of normal, CASODEX should be immediately discontinued with close follow-up of liver function.

5.2. Gynecomastia and Breast Pain

In clinical trials with CASODEX 150 mg as a single agent for prostate cancer, gynecomastia and breast pain have been reported in up to 38% and 39% of patients, respectively.

5.3. Glucose Tolerance

A reduction in glucose tolerance has been observed in males receiving LHRH agonists. This may manifest as diabetes or loss of glycemic control in those with pre-existing diabetes. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX in combination with LHRH agonists.

5.4. Laboratory Tests

Regular assessments of serum Prostate Specific Antigen (PSA) may be helpful in monitoring the patient’s response. If PSA levels rise during CASODEX therapy, the patient should be evaluated for clinical progression. For patients who have objective progression of disease together with an elevated PSA, a treatment-free period of antiandrogen, while continuing the LHRH analog, may be considered.

6. ADVERSE REACTIONS

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.

6.1. Clinical Trials Experience

In patients with advanced prostate cancer treated with CASODEX 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 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-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-LHRH analog treated and flutamide-LHRH analog treated patients.

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