Bicalutamide (Casodex)
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Bicalutamide (Casodex)

CASODEX®
(bicalutamide) Tablet for Oral use

DRUG DESCRIPTION

CASODEX® (bicalutamide) Tablets contain 50 mg of bicalutamide, a non-steroidal androgen receptor inhibitor with no other known endocrine activity. The chemical name is propanamide, N [4 cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-). The structural and empirical formulas are:

CASODEX® (bicalutamide) Structural Formula Illustration

Bicalutamide has a molecular weight of 430.37. The pKa' is approximately 12. Bicalutamide is a fine white to off white powder which is practically insoluble in water at 37°C (5 mg per 1000 mL), slightly soluble in chloroform and absolute ethanol, sparingly soluble in methanol, and soluble in acetone and tetrahydrofuran.

CASODEX (bicalutamide) is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of bicalutamide; the S-enantiomer is essentially inactive.

The inactive ingredients of CASODEX (bicalutamide) Tablets are lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, and titanium dioxide.

What are the possible side effects of bicalutamide (Casodex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, cough or trouble breathing;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands or feet;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • blood in your urine; or
  • nausea, pain in your upper stomach, itching, dark urine, clay-colored...

Read All Potential Side Effects and See Pictures of Casodex »

What are the precautions when taking bicalutamide (Casodex)?

Before taking bicalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, lung/breathing problems.

When higher doses (150 milligrams per day) of this medication are used in patients with early-stage localized prostate cancer, more deaths have occurred than in patients whose doctors decided to monitor them closely before treating with this medication. Ask your doctor for more details and discuss the risks and benefits of your treatment.

This drug may make you...

Read All Potential Precautions of Casodex »

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

INDICATIONS

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

DOSAGE AND ADMINISTRATION

The recommended dose for CASODEX (bicalutamide) 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 (bicalutamide) be taken at the same time each day. Treatment with CASODEX (bicalutamide) should be started at the same time as treatment with an LHRH analog.

Dosage Adjustment in Renal Impairment

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

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].

HOW SUPPLIED

Dosage Forms And Strengths

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

White, film-coated tablets (identified on one side with "CDX50" and on the reverse with the "CASODEX (bicalutamide) logo") are supplied in unit dose blisters of 30 tablets per carton (0310-0705-39), bottles of 30 tablets (0310-0705-30) and bottles of 100 tablets (0310-0705-10).

Storage and Handling

Store at controlled room temperature, 20°-25°C (68°-77°F).

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850.

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

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.

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

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hepatitis

Rare cases of death or hospitalization due to severe liver injury have been reported post-marketing in association with the use of CASODEX (bicalutamide) . 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 (bicalutamide) patients in controlled clinical trials.

Serum transaminase levels should be measured prior to starting treatment with CASODEX (bicalutamide) , 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 (bicalutamide) should be immediately discontinued with close follow-up of liver function.

Gynecomastia and Breast Pain

In clinical trials with CASODEX (bicalutamide) 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.

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 (bicalutamide) in combination with LHRH agonists.

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 (bicalutamide) 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.

Patient Counseling Information

Patients should be informed that therapy with CASODEX (bicalutamide) and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with CASODEX (bicalutamide) , somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX (bicalutamide) in combination with LHRH agonists.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Two-year oral carcinogenicity studies were conducted in both male and female rats and mice at doses of 5, 15 or 75 mg/kg/day of bicalutamide. A variety of tumor target organ effects were identified and were attributed to the antiandrogenicity of bicalutamide, namely, testicular benign interstitial (Leydig) cell tumors in male rats at all dose levels (the steady-state plasma concentration with the 5 mg/kg/day dose is approximately 2/3 human therapeutic concentrations*) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1 1/2 times the human therapeutic concentrations*). There is no evidence of Leydig cell hyperplasia in patients; uterine tumors are not relevant to the indicated patient population.

A small increase in the incidence of hepatocellular carcinoma in male mice given 75 mg/kg/day of bicalutamide (approximately 4 times human therapeutic concentrations*) and an increased incidence of benign thyroid follicular cell adenomas in rats given 5 mg/kg/day (approximately 2/3 human therapeutic concentrations*) and above were recorded. These neoplastic changes were progressions of non-neoplastic changes related to hepatic enzyme induction observed in animal toxicity studies. Enzyme induction has not been observed following bicalutamide administration in man. There were no tumorigenic effects suggestive of genotoxic carcinogenesis.

A comprehensive battery of both in vitro and in vivo genotoxicity tests (yeast gene conversion, Ames, E. coli, CHO/HGPRT, human lymphocyte cytogenetic, mouse micronucleus, and rat bone marrow cytogenetic tests) has demonstrated that CASODEX (bicalutamide) does not have genotoxic activity.

Administration of CASODEX (bicalutamide) may lead to inhibition of spermatogenesis. The long-term effects of CASODEX (bicalutamide) on male fertility have not been studied.

In male rats dosed at 250 mg/kg/day (approximately 2 times human therapeutic concentrations*), the precoital interval and time to successful mating were increased in the first pairing but no effects on fertility following successful mating were seen. These effects were reversed by 7 weeks after the end of an 11-week period of dosing.

No effects on female rats dosed at 10, 50 and 250 mg/kg/day (approximately 2/3, 1 and 2 times human therapeutic concentrations, respectively*) or their female offspring were observed. Administration of bicalutamide to pregnant females resulted in feminization of the male offspring leading to hypospadias at all dose levels. Affected male offspring were also impotent.

Use In Specific Populations

Pregnancy

PREGNANCY CATEGORY X [see CONTRAINDICATIONS]. Based on its mechanism of action, CASODEX (bicalutamide) may cause fetal harm when administered to a pregnant woman. CASODEX (bicalutamide) is contraindicated in women, including those who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

While there are no human data on the use of CASODEX (bicalutamide) in pregnancy and CASODEX (bicalutamide) is not for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus.

In animal reproduction studies, male offspring of rats receiving doses of 10 mg/kg/day (approximately 2/3 of clinical exposure at the recommended dose) and above, were observed to have reduced anogenital distance and hypospadias. These pharmacological effects have been observed with other antiandrogens. No other teratogenic effects were observed in rabbits receiving doses up to 200 mg/kg/day (approximately 1/3 of clinical exposure at the recommended dose) or rats receiving doses up to 250 mg/kg/day (approximately 2 times the clinical exposure at the recommended dose).

Nursing Mothers

CASODEX (bicalutamide) is not indicated for use in women.

Pediatric Use

The safety and effectiveness of CASODEX (bicalutamide) in pediatric patients have not been established.

CASODEX (bicalutamide) orodispersible tablet was studied in combination with ARIMIDEX (anastrozole) orodispersible tablet in an open-label, non-comparative, multi-center study that assessed the efficacy and safety of this combination regimen over 12 months in the treatment of gonadotropin-independent precocious puberty in boys with familial male-limited precocious puberty, also known as testotoxicosis. Patients were enrolled in the study if they had a baseline age ≥ 2 years and a diagnosis of testotoxicosis based on clinical features of progressive precocious puberty, symmetrical testicular enlargement, advanced bone age, pubertal levels of serum testosterone, prepubertal pattern of gonadotropin secretion following a GnRH stimulation test, and absence of other clinical and biochemical causes of testosterone excess. Thirteen out of the 14 patients enrolled completed 12 months of combination treatment (one patient was lost to follow-up). If central precocious puberty (CPP) developed an LHRH analog was to be added. Four patients were diagnosed with CPP during the 12-month study and received LHRH analog treatment and 2 additional patients were diagnosed at the end of the 12 months and received treatment subsequently. Mean ± SD characteristics at baseline were as follows: chronological age: 3.9 ± 1.9 years; bone age 8.8 ± 2.5; bone age/chronological age ratio: 2.06 ± 0.51; growth rate (cm/yr): 10.81 ± 4.22; growth rate standard deviation score (SDS): 0.41 ± 1.36.

The starting CASODEX (bicalutamide) dose was 12.5 mg. CASODEX (bicalutamide) was titrated in each patient until steady-state R-bicalutamide (the active isomer of bicalutamide) trough plasma concentration reached 5-15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently approved CASODEX (bicalutamide) dose of 50 mg. The starting daily dose of anastrozole was 0.5 mg. Anastrozole was independently titrated in each patient until it reached at steady-state a serum estradiol concentration of < 10 pmol/L (2.7 pg/mL). The following ascending doses were used for CASODEX (bicalutamide) : 12.5 mg, 25 mg, 50 mg, and 100 mg. For anastrozole there were two ascending doses: 0.5 mg and 1 mg. At the end of the titration phase 1 patient was on 12.5 mg CASODEX (bicalutamide) , 8 patients were on 50 mg CASODEX (bicalutamide) , and 4 patients were on 100 mg CASODEX (bicalutamide) ; 10 patients were on 0.5 mg anastrozole and 3 patients were on 1 mg anastrozole. In the majority of patients, steady-state trough concentrations of R-bicalutamide appeared to be attained by Day 21 with once daily dosing. Steady-state trough plasma anastrozole concentrations appeared to be attained by Day 8.

The primary efficacy analysis of the study was to assess the change in growth rate after 12 months of treatment, relative to the growth rate during the ≥ 6 months prior to entering the study. Pre-study growth rates were obtained retrospectively. There was no statistical evidence that the growth rate was reduced during treatment. During CASODEX (bicalutamide) /ARIMIDEX treatment the mean growth rate (cm/yr) decreased by 1.6 cm/year, 95% CI (-4.7 to 1.5) p=0.28; the mean growth rate SDS decreased by 0.1 SD, 95% CI (–1.2 to 1.0) p=0.88. Table 2 shows descriptive data for growth rates for the overall population and for subgroups defined by history of previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors.

Table 2. Growth rates

Endpoint Analysis population Pre-study Mean Change from pre-study to 12 months % patients with growth reduction1
Mean Median (Min, Max)
Growth rate (cm/yr) All treated (n=13) 10.8 -1.6 -2.8 (-7.4, 8.4) 9/13 (69%)
PT2 (n=6) 10.3 -0.2 -2.6 4 (-7.2, 8.4) 4/6 (67%)
NPT3(n=7) 11.2 -2.8 -2.8 (-7.4, 1.1) 5/7 (71%)
 
Growth rate (SD units) All treated (n=13) 0.4 -0.1 -0.4 (-2.7, 3.5) 9/13 (69%)
PT 2 (n=6) -0.1 +0.7 -0.2 4 (-1.6, 3.5) 4/6 (67%)
NPT3 (n=7) 0.8 -0.7 -0.4 (-2.7, 0.5) 5/7 (71%)
1 Change compared to pre-study growth rate
2 PT = Previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrazole or other aromatase inhibitors
3 NPT = no previous treatment for testotoxicosis with ketoconazole, spironolactone, anastrozole or other aromatase inhibitors
4 Median calculated as midpoint of 3rd and 4th ranked observations

Total testosterone concentrations increased by a mean of 5 mmol/L over the 12 months of treatment from a baseline mean of 10 mmol/L. Estradiol concentrations were at or below the level of quantification (9.81 pmol/L) for 11 of 12 patients after 12 months of treatment. Six of the 12 patients started treatment at an estradiol concentration below the level of quantification.

There were no deaths, serious adverse events, or discontinuations due to adverse events during the study. Of the 14 patients exposed to study treatment, 13 (92.9%) experienced at least one adverse event. The most frequently reported ( > 3 patients) adverse events were gynecomastia (7/14, 50%), central precocious puberty (6/14, 43%), vomiting (5/14, 36%), headache (3/14, 21%), pyrexia (3/14, 21%) and upper respiratory tract infection (3/14, 21%). Adverse reactions considered possibly related to bicalutamide by investigators included gynecomastia (6/14, 43%), central precocious puberty (2/14, 14%), breast tenderness (2/14, 14%), breast pain (1/14, 7%), asthenia (1/14, 7%), increased alanine aminotransferase [ALT] (1/14, 7%), increased aspartate aminotransferase [AST] (1/14, 7%), and musculoskeletal chest pain (1/14, 7%). Headache was the only adverse reaction considered possibly related to anastrazole by investigators. For the patient who developed elevated ALT and AST, the elevation was < 3X ULN, and returned to normal without stopping treatment; there was no concomitant elevation in total bilirubin.

Geriatric Use

In two studies in patients given 50 or 150 mg daily, no significant relationship between age and steady-state levels of total bicalutamide or the active R-enantiomer has been shown.

Hepatic Impairment

CASODEX (bicalutamide) should be used with caution in patients with moderate-to-severe hepatic impairment. CASODEX (bicalutamide) is extensively metabolized by the liver. Limited data in subjects with severe hepatic impairment suggest that excretion of CASODEX (bicalutamide) may be delayed and could lead to further accumulation. Periodic liver function tests should be considered for hepatic-impaired patients on long-term therapy [see WARNINGS AND PRECAUTIONS].

No clinically significant difference in the pharmacokinetics of either enantiomer of bicalutamide was noted in patients with mild-to-moderate hepatic disease as compared to healthy controls. However, the half-life of the R-enantiomer was increased approximately 76% (5.9 and 10.4 days for normal and impaired patients, respectively) in patients with severe liver disease (n=4).

Renal Impairment

Renal impairment (as measured by creatinine clearance) had no significant effect on the elimination of total bicalutamide or the active R-enantiomer.

Women

Bicalutamide has not been studied in women.

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

OVERDOSE

Long-term clinical trials have been conducted with dosages up to 200 mg of CASODEX (bicalutamide) daily and these dosages have been well tolerated. A single dose of CASODEX (bicalutamide) that results in symptoms of an overdose considered to be life threatening has not been established.

There is no specific antidote; treatment of an overdose should be symptomatic.

In the management of an overdose with CASODEX (bicalutamide) , vomiting may be induced if the patient is alert. It should be remembered that, in this patient population, multiple drugs may have been taken. Dialysis is not likely to be helpful since CASODEX (bicalutamide) is highly protein bound and is extensively metabolized. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

CONTRAINDICATIONS

Hypersensitivity

CASODEX (bicalutamide) 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 SIDE EFFECTS].

Women

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

Pregnancy

CASODEX (bicalutamide) may cause fetal harm when administered to a pregnant woman. CASODEX (bicalutamide) is contraindicated in women, including those who are or may become pregnant. There are no studies in pregnant women using CASODEX (bicalutamide) . 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].

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

CLINICAL PHARMACOLOGY

Mechanism of Action

CASODEX (bicalutamide) is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.

When CASODEX (bicalutamide) is combined with luteinizing hormone releasing hormone (LHRH) analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. However, in clinical trials with CASODEX (bicalutamide) as a single agent for prostate cancer, rises in serum testosterone and estradiol have been noted.

In a subset of patients who have been treated with CASODEX (bicalutamide) and an LHRH agonist, and who discontinue CASODEX (bicalutamide) therapy due to progressive advanced prostate cancer, a reduction in Prostate Specific Antigen (PSA) and/or clinical improvement (antiandrogen withdrawal phenomenon) may be observed.

Pharmacokinetics

Absorption

Bicalutamide is well-absorbed following oral administration, although the absolute bioavailability is unknown. Co-administration of bicalutamide with food has no clinically significant effect on rate or extent of absorption.

Distribution

Bicalutamide is highly protein-bound (96%) [see DRUG INTERACTIONS].

Metabolism/Elimination

Bicalutamide undergoes stereospecific metabolism. The S (inactive) isomer is metabolized primarily by glucuronidation. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Both the parent and metabolite glucuronides are eliminated in the urine and feces. The S-enantiomer is rapidly cleared relative to the R-enantiomer, with the R-enantiomer accounting for about 99% of total steady-state plasma levels.

Pharmacokinetics of the active enantiomer of CASODEX (bicalutamide) in normal males and patients with prostate cancer are presented in Table 3.

Table 3

Parameter Mean Standard Deviation
Normal Males (n=30)
Apparent Oral Clearance (L/hr) 0.320 0.103
Single Dose Peak Concentration (µg/mL) 0.768 0.178
Single Dose Time to Peak Concentration (hours) 31.3 14.6
Half-life (days) 5.8 2.29
Patients with Prostate Cancer (n=40)
Css (µg/mL) 8.939 3.504

Clinical Studies

CASODEX (bicalutamide) 50 mg Daily in Combination with an LHRH-A

In a multicenter, double-blind, controlled clinical trial, 813 patients with previously untreated advanced prostate cancer were randomized to receive CASODEX (bicalutamide) 50 mg once daily (404 patients) or flutamide 250 mg (409 patients) three times a day, each in combination with LHRH analogs (either goserelin acetate implant or leuprolide acetate depot).

In an analysis conducted after a median follow-up of 160 weeks was reached, 213 (52.7%) patients treated with CASODEX (bicalutamide) -LHRH analog therapy and 235 (57.5%) patients treated with flutamide-LHRH analog therapy had died. There was no significant difference in survival between treatment groups (see Figure 1). The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05).

Figure 1 - The Kaplan-Meier probability of death for both antiandrogen treatment groups.

The Kaplan-Meier probability of death for both antiandrogen treatment groups - Illustration

There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2).

Objective tumor progression was defined as the appearance of any bone metastases or the worsening of any existing bone metastases on bone scan attributable to metastatic disease, or an increase by 25% or more of any existing measurable extraskeletal metastases. The hazard ratio for time to progression of CASODEX (bicalutamide) plus LHRH analog to that of flutamide plus LHRH analog was 0.93 (95% confidence interval, 0.79 to 1.10).

Figure 2 - Kaplan-Meier curve for time to progression for both antiandrogen treatment groups.

Kaplan-Meier curve for time to progression for both antiandrogen treatment groups - Illustration

Quality of life was assessed with self-administered patient questionnaires on pain, social functioning, emotional well being, vitality, activity limitation, bed disability, overall health, physical capacity, general symptoms, and treatment related symptoms. Assessment of the Quality of Life questionnaires did not indicate consistent significant differences between the two treatment groups.

Safety Data from Clinical Studies using CASODEX (bicalutamide) 150 mg

CASODEX (bicalutamide) 150 mg is not approved for use either alone or with other treatments.

Two identical multicenter, randomized, open-label trials comparing CASODEX (bicalutamide) 150 mg daily monotherapy to castration were conducted in patients that had locally advanced (T3-4, NX, MO) or metastatic (M1) prostate cancer.

Monotherapy — M1 Group

CASODEX (bicalutamide) 150 mg daily is not approved for use in patients with M1 cancer of the prostate. Based on an interim analysis of the two trials for survival, the Data Safety Monitoring Board recommended that CASODEX (bicalutamide) treatment be discontinued in the M1 patients because the risk of death was 25% (HR 1.25, 95% CI 0.87 to 1.81) and 31% (HR 1.31, 95% CI 0.97 to 1.77) higher in the CASODEX (bicalutamide) treated group compared to that in the castrated group, respectively.

Locally Advanced (T3-4, NX, MO) Group

CASODEX (bicalutamide) 150 mg daily is not approved for use in patients with locally advanced (T3-4, NX, M0) cancer of the prostate. Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, MO patients until study completion. In the larger trial (N=352), the risk of death was 25% (HR 1.25, 95% CI 0.92 to 1.71) higher in the CASODEX (bicalutamide) group and in the smaller trial (N=140), the risk of death was 36% (HR 0.64, 95% CI, 0.39 to 1.03) lower in the CASODEX (bicalutamide) group.

In addition to the above two studies, there are three other on-going clinical studies that provide additional safety information for CASODEX (bicalutamide) 150 mg, a dose that is not approved for use. These are three multicenter, randomized, double-blind, parallel group trials comparing CASODEX (bicalutamide) 150 mg daily monotherapy (adjuvant to previous therapy or under watchful waiting) with placebo, for death or time to disease progression, in a population of 8113 patients with localized or locally advanced prostate cancer.

CASODEX (bicalutamide) 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Data from a planned subgroup analysis of two of these trials in 1627 patients with localized prostate cancer who were under watchful waiting, revealed a trend toward decreased survival in the CASODEX (bicalutamide) arm after a median follow-up of 7.4 years. There were 294 (37.7%) deaths in the CASODEX (bicalutamide) treated patients versus 279 (32.9%) deaths in the placebo treated patients (localized watchful waiting group) for a hazard ratio of 1.16 (95% CI 0.99 to 1.37).

*Based on a maximum dose of 50 mg/day of bicalutamide for an average 70 kg patient.

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

PATIENT INFORMATION

CASODEX (bicalutamide) ®
[pronounced cas-o-dex]
(bicalutamide) Tablets

Patients should be informed that therapy with CASODEX (bicalutamide) and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with CASODEX (bicalutamide) , somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX (bicalutamide) in combination with LHRH agonists.

Read the Patient Information that comes with Casodex (bicalutamide) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Casodex (bicalutamide) ?

CASODEX (bicalutamide) is a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Casodex (bicalutamide) is safe and effective in children.

Who should not take Casodex (bicalutamide) ?

Do not take Casodex (bicalutamide) if:

  • you are a woman.
  • you are allergic to any of the ingredients in Casodex (bicalutamide) . See the end of this leaflet for a complete list of ingredients

What should I tell my healthcare provider before taking Casodex (bicalutamide) ?

Before you take Casodex (bicalutamide) , tell your healthcare provider about all your medical conditions including if you:

  • are a woman (see who should not take Casodex (bicalutamide) )
  • are pregnant or think you may be pregnant
  • have liver problems
  • take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.
  • have diabetes (poor blood sugar control has been reported in people taking Casodex (bicalutamide) in combination with LHRH medicines)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Casodex (bicalutamide) and other medicines may affect each other causing side effects. Casodex (bicalutamide) may affect the way other medicines work, and other medicines may affect how Casodex (bicalutamide) works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Casodex (bicalutamide) ?

  • Take Casodex (bicalutamide) exactly as prescribed.
  • Take Casodex (bicalutamide) at the same time everyday.
  • Your treatment with Casodex (bicalutamide) should start at the same time as your treatment with the LHRH medicine
  • If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.
  • Casodex (bicalutamide) can be taken with or without food.
  • If you take too much Casodex (bicalutamide) , call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
  • Do not stop taking Casodex (bicalutamide) unless your healthcare provider tells you.
  • Your healthcare provider may do blood tests while you take Casodex (bicalutamide)
  • Your prostate cancer may get worse while taking Casodex (bicalutamide) in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Casodex (bicalutamide) ?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Casodex (bicalutamide) affects you.

What are the possible side effects of Casodex (bicalutamide) ?

Casodex (bicalutamide) can cause serious side effects. Get medical help right away, if you have:

The most common side effects of Casodex (bicalutamide) include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Casodex (bicalutamide) . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE CASODEX (bicalutamide) ?

Store Casodex (bicalutamide) between 20°C-25°C (68°F-77°F).

Keep Casodex (bicalutamide) and all medicines out of the reach of children.

General information about the safe and effective use of Casodex (bicalutamide) .

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Casodex (bicalutamide) for a condition for which it was not prescribed. Do not give Casodex (bicalutamide) to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Casodex (bicalutamide) . If you would like more information about Casodex (bicalutamide) talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Casodex (bicalutamide) that is written for health professionals. For more information go to www.Casodex (bicalutamide) .com or call 1-800-236-9933.

What are the ingredients in Casodex?

Active ingredients include: bicalutamide

Inactive ingredients include: lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, titanium dioxide

Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

CASODEX (bicalutamide) ®
[pronounced cas-o-dex]
(bicalutamide) Tablets

Patients should be informed that therapy with CASODEX (bicalutamide) and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with CASODEX (bicalutamide) , somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving CASODEX (bicalutamide) in combination with LHRH agonists.

Read the Patient Information that comes with Casodex (bicalutamide) before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is Casodex (bicalutamide) ?

CASODEX (bicalutamide) is a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Casodex (bicalutamide) is safe and effective in children.

Who should not take Casodex (bicalutamide) ?

Do not take Casodex (bicalutamide) if:

  • you are a woman.
  • you are allergic to any of the ingredients in Casodex (bicalutamide) . See the end of this leaflet for a complete list of ingredients

What should I tell my healthcare provider before taking Casodex (bicalutamide) ?

Before you take Casodex (bicalutamide) , tell your healthcare provider about all your medical conditions including if you:

  • are a woman (see who should not take Casodex (bicalutamide) )
  • are pregnant or think you may be pregnant
  • have liver problems
  • take a medicine to thin your blood. Ask your healthcare provider or pharmacist if you are not sure if your medicine is a blood thinner.
  • have diabetes (poor blood sugar control has been reported in people taking Casodex (bicalutamide) in combination with LHRH medicines)

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Casodex (bicalutamide) and other medicines may affect each other causing side effects. Casodex (bicalutamide) may affect the way other medicines work, and other medicines may affect how Casodex (bicalutamide) works.

Know the medicines you take. Keep a list of your medicines with you to show your healthcare providers when you get a new medicine.

How should I take Casodex (bicalutamide) ?

  • Take Casodex (bicalutamide) exactly as prescribed.
  • Take Casodex (bicalutamide) at the same time everyday.
  • Your treatment with Casodex (bicalutamide) should start at the same time as your treatment with the LHRH medicine
  • If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.
  • Casodex (bicalutamide) can be taken with or without food.
  • If you take too much Casodex (bicalutamide) , call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
  • Do not stop taking Casodex (bicalutamide) unless your healthcare provider tells you.
  • Your healthcare provider may do blood tests while you take Casodex (bicalutamide)
  • Your prostate cancer may get worse while taking Casodex (bicalutamide) in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What should I avoid while taking Casodex (bicalutamide) ?

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Casodex (bicalutamide) affects you.

What are the possible side effects of Casodex (bicalutamide) ?

Casodex (bicalutamide) can cause serious side effects. Get medical help right away, if you have:

The most common side effects of Casodex (bicalutamide) include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Casodex (bicalutamide) . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

HOW SHOULD I STORE CASODEX (bicalutamide) ?

Store Casodex (bicalutamide) between 20°C-25°C (68°F-77°F).

Keep Casodex (bicalutamide) and all medicines out of the reach of children.

General information about the safe and effective use of Casodex (bicalutamide) .

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Casodex (bicalutamide) for a condition for which it was not prescribed. Do not give Casodex (bicalutamide) to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Casodex (bicalutamide) . If you would like more information about Casodex (bicalutamide) talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Casodex (bicalutamide) that is written for health professionals. For more information go to www.Casodex (bicalutamide) .com or call 1-800-236-9933.

What are the ingredients in Casodex?

Active ingredients include: bicalutamide

Inactive ingredients include: lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, titanium dioxide

Last reviewed on RxList: 2/17/2009
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Casodex Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BICALUTAMIDE - ORAL

(bye-ka-LOO-ta-mide)

COMMON BRAND NAME(S): Casodex

USES: Bicalutamide is used to treat prostate cancer that has spread to other areas of the body. It is used in combination with hormone treatment. This medication works by blocking the action of male hormones in the prostate, slowing growth of the tumors.

This medication should not be used in women or children.

HOW TO USE: Take this medication by mouth, usually once a day in the morning or evening, with or without food, or as directed by your doctor.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. The dosage is based on your medical condition and response to therapy.

Do not increase your dose or take this medication more often without your doctor's approval. Your condition will not improve any faster, and the risk of serious side effects may be increased.

Since this drug can be absorbed through the skin, women who are pregnant or who may become pregnant should not handle this medication.

Disclaimer

Casodex Consumer (continued)

SIDE EFFECTS: Flushing and sweating (hot flashes), body aches and pains, breast swelling/tenderness/pain, headache, dizziness, drowsiness, trouble sleeping, weakness, hair loss, weight changes, constipation, diarrhea, stomach upset, gas, nausea, vomiting, and loss of appetite may occur.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual ability/desire, vision changes, numbness/tingling of the hands or feet, swelling of the arms/legs, unusual or easy bleeding/bruising, change in the amount of urine, painful urination, signs of infection (e.g., fever, chills, persistent sore throat), trouble breathing, persistent cough, mental/mood changes (e.g., anxiety, depression).

Seek immediate medical attention if any of these very serious side effects occur: chest pain, jaw/left arm pain.

Rarely, bicalutamide may cause growth of other types of tumors. Consult your doctor immediately if new lumps or growths occur.

This medication may rarely cause serious (possibly fatal) liver disease. Seek immediate medical attention if any of these side effects occur: dark urine, yellowing of the eyes/skin, unusual tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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

PRECAUTIONS: Before taking bicalutamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, diabetes, lung/breathing problems.

When higher doses (150 milligrams per day) of this medication are used in patients with early-stage localized prostate cancer, more deaths have occurred than in patients whose doctors decided to monitor them closely before treating with this medication. Ask your doctor for more details and discuss the risks and benefits of your treatment.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. To minimize these effects and flushing of the face, limit alcoholic beverages.

Bicalutamide should not be used in women or children. It must not be used in a woman who may be pregnant or breast-feeding. This medication may cause harm to an unborn or breast-feeding baby.

Disclaimer

Casodex Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., prostate specific antigen-PSA levels, liver and kidney function tests, blood sugar, complete blood counts) should be performed to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best benefits, it is important to take this medication as directed. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

Information last revised March 2011. Copyright(c) 2011 First Databank, Inc.

Casodex Patient Information Including Side Effects

Brand Names: Casodex

Generic Name: bicalutamide (Pronunciation: bye ka LOO ta mide)

What is bicalutamide (Casodex)?

Bicalutamide is an anti-androgen. It works in the body by preventing the actions of androgens (male hormones).

Bicalutamide is used together with another hormone to treat prostate cancer.

Bicalutamide may also be used for purposes not listed in this medication guide.

Bicalutamide 50 mg-TEV

round, white, imprinted with 93, 220

What are the possible side effects of bicalutamide (Casodex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, cough or trouble breathing;
  • feeling short of breath, even with mild exertion;
  • swelling in your hands or feet;
  • fever, chills, body aches, flu symptoms;
  • pale skin, easy bruising or bleeding;
  • blood in your urine; or
  • nausea, pain in your upper stomach, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • hot flashes;
  • breast pain or swelling;
  • weakness, dizziness;
  • back pain, pelvic pain, joint or muscle pain;
  • increased nighttime urination;
  • upset stomach, vomiting, diarrhea or constipation;
  • weight changes;
  • impotence, loss of interest in sex, or trouble having an orgasm;
  • dizziness, headache; or
  • sore throat, runny nose or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

What is the most important information I should know about bicalutamide (Casodex)?

Before taking this medication, tell your doctor if you have liver disease, diabetes, or any other serious illness.

Bicalutamide is given as part of a combination prostate cancer treatment with another medication that prevents the testicles from producing testosterone.

Your doctor may occasionally change your dose to make sure you get the best results. Do not stop taking bicalutamide without your doctor's advice. If you stop your treatment suddenly, your condition may become worse.

To be sure this medication is helping your condition and is not causing harmful effects, your prostate and liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

Call your doctor at once if you have a serious side effect such as chest pain, shortness of breath, swelling, blood in your urine, or stomach pain with loss of appetite, dark urine, and yellowing of your skin or eyes.

Bicalutamide should never be taken by a woman or a child.

Although bicalutamide is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy.

Side Effects Centers

Casodex Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking bicalutamide (Casodex)?

You should not use this medication if you are allergic to bicalutamide.

Bicalutamide should never be taken by a woman or a child.

To make sure you can safely take bicalutamide, tell your doctor if you have liver disease, diabetes, or any other serious illness.

Although bicalutamide is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy.

How should I take bicalutamide (Casodex)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Bicalutamide is given as part of a combination prostate cancer treatment with another medication called a luteinizing (LOO-tee-in-ize-ing) hormone-releasing hormone, or LHRH. This medication prevents the testicles from producing testosterone.

Treatment with bicalutamide and LHRH is usually started at the same time. Follow your doctor's instructions.

Bicalutamide is usually taken once per day in the morning or evening. You may take the medicine with or without food. Try to take the medication at the same time each day.

LHRH is given as an injection or a tiny implant injected through a needle under the skin around your navel. LHRH injections are given at intervals such as once every 4 weeks. Follow your doctor's instructions.

Your doctor may occasionally change your dose to make sure you get the best results. Do not stop taking bicalutamide without your doctor's advice. If you stop your treatment suddenly, your condition may become worse.

To be sure this medication is helping your condition and is not causing harmful effects, your prostate and liver function will need to be checked with frequent blood tests. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers

Casodex Patient Information including If I Miss a Dose

What happens if I miss a dose (Casodex)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss an appointment for your LHRH injection.

What happens if I overdose (Casodex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking bicalutamide (Casodex)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect bicalutamide (Casodex)?

Before taking this medication, tell your doctor if you are taking a blood thinner such as warfarin (Coumadin).

There may be other drugs that can interact with bicalutamide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about bicalutamide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

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