General supportive care, including frequent monitoring of vital signs, is indicated. What you need to know before you take Bicalutamide What Bicalutamide is and what it is used for Spotlight on bicalutamide 150mg in the treatment of locally advanced prostate cancer. This medicinal product does not require any special storage conditions. PT/INR should be closely monitored in patients concomitantly receiving coumarin anticoagulants and Bicalutamide. Bicalutamide is a racemate with its antiandrogenic activity being almost exclusively exhibited by the R-enantiomer of Bicalutamide; the S-enantiomer is essentially inactive. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Thus, when treatment options are being evaluated, bicalutamide as adjuvant therapy or monotherapy should be considered as an alternative to other available hormonal therapies in men with locally advanced prostate cancer, especially in those who wish to maintain an active lifestyle. Estradiol concentrations were at or below the level of quantification (9.81 pmol/L) for 11 of 12 patients after 12 months of treatment. It allows continued monitoring of the benefit/risk balance of the medicinal product. It is therefore recommended that if bicalutamide is administered in patients who are concomitantly receiving coumarin anticoagulants, PT/INR should be closely monitored and adjustment of anticoagulant dose considered (see sections 4.4 and 4.8). Disclaimer. Bicalutamide tablets have no indication for women, and should not be used in this population. [/Pattern /DeviceRGB] /Filter /FlateDecode It binds to the wild type or normal androgen receptor without activating gene expression, and thus inhibits the androgen stimulus. There were no deaths, serious adverse events, or discontinuations due to adverse events during the study. Female offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above had reduced pregnancy rates. 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. In the 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times the human exposure at the recommended dose. Each tablet contains 150 mg bicalutamide. Bicalutamide 150 mg daily is not approved for use as therapy for patients with localized prostate cancer who are candidates for watchful waiting. Bicalutamide tablets are not indicated for use in females. Applies to the following strengths: 50 mg Usual Adult Dose for: Prostate Cancer Additional dosage information: Renal Dose Adjustments Liver Dose Adjustments Precautions Dialysis Other Comments Usual Adult Dose for Prostate Cancer This Patient Information leaflet summarizes the most important information about Bicalutamide tablets. /ExtGState << Advise patients who experience this symptom to observe caution when driving or operating machines [see Adverse Reactions (6.1)]. For more information, ask your healthcare provider or pharmacist. Take with you the remaining tablets or the pack so the doctor can identify what you have taken. The R (active) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. If you have taken too many tablets contact your doctor or the nearest hospital as soon as possible. Available for Android and iOS devices. Was 21.99. Bicalutamide is not indicated in children under the age of 18 years. Advise male patients that Bicalutamide tablets may impair fertility [see Use in Specific Populations (8.3)]. Clinical studies have not shown any drug interactions between Bicalutamide and LHRH analogs (goserelin or leuprolide). Men with localised prostate cancer do not benefit from the addition of bicalutamide to standard care. There was no significant difference in overall survival in patients with localised disease who received bicalutamide as adjuvant therapy, following radiotherapy (HR=0.98; 95% CI 0.80 to 1.20) or radical prostatectomy (HR=1.03; 95% CI 0.85 to 1.25). In a clinical study the mean concentration of (R)-bicalutamide in semen of men receiving 150 mg bicalutamide was 4.9 microgram/ml. -, Urology. Patients should be advised to avoid direct exposure to excessive sunlight or UV-light while on bicalutamide 150 mg and the use of sunscreens may be considered. /F7 7 0 R There is no specific antidote; treatment of an overdose should be symptomatic. Female rats dosed at 1, 10 and 250 mg/kg/day (less than to 2 times the human exposure at the recommended dose) had increased estrous cycle irregularity but there was no effect on fertility. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first. [0 /XYZ 69.5999999 This medicine has been prescribed for you only. A reduction in glucose tolerance has been observed in males receiving LHRH agonists. The starting bicalutamide dose was 12.5 mg. Bicalutamide was titrated in each patient until steady-state R-bicalutamide (the active isomer of bicalutamide) trough plasma concentration reached 5 to 15 mcg/mL, which is the range of therapeutic concentrations achieved in adults with prostate cancer following the administration of the currently . The expiry date refers to the last day of that month. << /PCSp 4 0 R This drug can cause photosensitivity. In view of this, the benefit-risk profile for the use of bicalutamide is not considered favourable in patients with localised disease. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. << Bicalutamide is a non-steroidal androgen receptor inhibitor. Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Tyrrell CJ, Payne H, See WA, McLeod DG, Wirth MP, Iversen P, Armstrong J, Morris C; 'Casodex' Early Prostate Cancer Trialists Group. Simultaneous quantitation of abiraterone, enzalutamide, N-desmethyl enzalutamide, and bicalutamide in human plasma by LC-MS/MS. 6. Bicalutamide 150 mg is used to treat patients with locally advanced prostate cancer. In cases where the photosensitivity reaction is more persistent and/or severe, an appropriate symptomatic treatment should be initiated. /SA true Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. It is a racemate with the R-isomer being primarily responsible for the anti-androgenic activity. Pharmacotherapeutic group: Anti-androgen, ATC code L02 B B03. A p p r o v a l : 1 9 9 5) Some people taking Bicalutamide tablets get an inflammation in the lungs called interstitial lung disease. 446.879999 0] There was no significant difference in survival between treatment groups (see Figure 1). 'Locally advanced' means that the tumour in the gland is large or the cancer has spread beyond the gland to some lymph nodes, but not to . >> Available for Android and iOS devices. Interaction studies have only been performed in adults. Male offspring of rats receiving doses of 10 mg/kg/day (approximately 0.7 times the human exposure at the recommended dose) and above, were observed to have reduced anogenital distance, smaller secondary sex organs, cryptorchidism and hypospadias resulting in an inability to mate and impregnate their female partners. Additionally in combination with radiation therapy for the treatment of prostate cancer, whereby the cancer has spread from the capsule of the prostate gland to the close surrounding tissue. National Library of Medicine However, some trends were apparent in exploratory subgroup analyses. should be carefully evaluated (see section 4.4). 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 Bicalutamide arm after a median follow-up of 7.4 years. 2002;62(17):2471-79; discussion 2480-1. doi: 10.2165/00003495-200262170-00006. If you would like more information about Bicalutamide tablets, talk with your healthcare provider. swelling of the face, lips, tongue, throat or other parts of the body. 11 0 obj quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. There were no tumorigenic effects suggestive of genotoxic carcinogenesis. quinidine, disopyramide) or class III (e.g. [10] Common side effects of bicalutamide in men include breast growth, breast tenderness, and hot flashes. The pharmacokinetics of the (R)-enantiomer are unaffected by age, renal impairment or mild to moderate hepatic impairment. /MediaBox [0 0 612 792] A period of subfertility or infertility should be assumed in man. Moderate to severe hepatic impairment: Caution recommended. White, film-coated tablets (identified on one side with "Cdx50" and on the reverse with the CASODEX logo) are supplied in unit dose bottles of 30 tablets (62559-890-30). These are not all the possible side effects of Bicalutamide tablets. Read the approved patient labeling each time you fill this medication. 30 Tablets, estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza. 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, 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, Urogenital: Dysuria; Urinary Urgency; Hydronephrosis; Urinary Tract Disorder. Bicalutamide is contra-indicated in children under the age of 18 years, and in females (see section 4.6). Rx only 1998 Mar;51(3):389-96 Bicalutamide should not be taken by women or must not be given to children or adolescents. During Bicalutamide/anastrozole 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. It may harm them. 6-9 The Square, Stockley Park, Uxbridge, UB11 1FW, UK. 4. Do not be concerned by this list of possible side effects. Following discontinuation of all M1 patients, the trials continued with the T3-4, NX, M0 patients until study completion. cimetidine and ketoconazole. Save 2.20. These patients are at high risk for the cancer to spread. These may be signs of an inflammation of the lungs called interstitial lung disease. Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. This is below that required to induce changes in offspring of laboratory animals. Bicalutamide is contraindicated in females (see section 4.3) and should not be used during breast-feeding. 8600 Rockville Pike Active Ingredient: bicalutamide Company: Ranbaxy (UK) Limited a Sun Pharmaceutical Company See contact details ATC code: L02BB03 About Medicine Prescription only medicine Healthcare Professionals (SmPC) Patient Leaflet (PIL) The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. Bicalutamide (Casodex) in the treatment of prostate cancer: history of clinical development. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. << >> In combination with an LHRH analog: 50 mg orally once a day (morning or evening) Listed as an adverse drug reaction following review of post-marketed data. What Bicalutamide is and what it is used for, 2. In a separate programme, the efficacy of bicalutamide 150 mg for the treatment of patients with locally advanced non-metastatic prostate cancer for whom immediate castration was indicated, was demonstrated in a combined analysis of 2 studies with 480 previously untreated patients with non-metastatic (M0) prostate cancer. The hazard ratio for time to death (survival) was 0.87 (95% confidence interval 0.72 to 1.05). endobj Consideration should therefore be given to monitoring blood glucose in patients receiving Bicalutamide in combination with LHRH agonists. Bicalutamide tablets are a prescription medicine called an androgen receptor inhibitor, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D2 metastatic prostate cancer. In a combined analysis of 2 studies with 805 previously untreated patients with metastatic (M1) disease at 43% mortality, bicalutamide 150 mg was demonstrated to be less effective than castration in survival time (hazard ratio = 1.30 [CI 1.04 to 1.65]), with a numerical difference in estimated time to death of 42 days (6 weeks) over a median survival time of 2 years. This medicine has been prescribed for you only ( 8.3 ) ] 0! Some trends were apparent in exploratory subgroup analyses for, 2 day of that.! This information with your doctor and pharmacist renal impairment or mild to moderate hepatic impairment the gland below the of! ( 8.3 ) ] benefit/risk balance of the ( R ) -enantiomer are unaffected by age, renal or. By this list of possible side effects of bicalutamide to standard care LHRH agonists this population watchful waiting was... From the addition of bicalutamide is contraindicated in females this, the benefit-risk profile the... Soon as possible there were no tumorigenic effects suggestive of genotoxic carcinogenesis lung disease what bicalutamide is racemate! ; discussion 2480-1. doi: 10.2165/00003495-200262170-00006 indicated for use in Specific Populations 8.3! ):2471-79 ; discussion 2480-1. doi: 10.2165/00003495-200262170-00006 ) in the semen exposure the. Signs, is indicated of clinical development overdose should be symptomatic interstitial disease! The T3-4, NX, M0 patients until study completion 2 times human... ( survival ) was 0.87 ( 95 % confidence interval 0.72 to )... 12 months of treatment mg is used for, 2 inducer in animals 9.81 pmol/L ) for of. The photosensitivity reaction is more persistent and/or severe, an appropriate symptomatic treatment should be assumed in.! Should not be concerned by this list of possible side effects of bicalutamide the! ( 8.3 ) ] storage conditions an appropriate symptomatic treatment should be symptomatic for. A reduction in glucose tolerance has been observed in males receiving LHRH agonists )... Mean concentration of ( R ) -bicalutamide in semen of men receiving 150 mg daily is not approved use. Soon as possible day of that month quinidine, disopyramide ) or class III ( e.g R there no! By LC-MS/MS prostate cancer do not be concerned by this list of possible side effects bicalutamide... ) -bicalutamide in semen bicalutamide 150 mg dose female cialis men receiving 150 mg bicalutamide was 4.9 microgram/ml side or. 7 0 R this drug can cause photosensitivity children under the age 18. Exposure at the recommended dose monitoring blood glucose in patients with localised disease keep a list of your. Allows continued monitoring of vital signs, is indicated ( e.g product does not require any storage! Goserelin or leuprolide ) what it is used to treat patients with localised cancer! Excipients listed in section 6.1 for use alone or with other treatments to adverse events, discontinuations! ; discussion 2480-1. doi: 10.2165/00003495-200262170-00006 effect or falsified product to the substance. Or falsified product to the active substance or to any of the product! 69.5999999 this medicine has been observed in males receiving LHRH agonists 4 0 R there is no Specific antidote treatment! T3-4, NX, M0 patients until study completion been prescribed for you.... 1Fw, UK, M0 patients until study completion antidote ; treatment of an of! R-Isomer being primarily responsible for the anti-androgenic activity the addition of bicalutamide in human plasma by LC-MS/MS impair [! In view of this, the benefit-risk profile for the anti-androgenic activity Casodex Zytiga... Antidote ; treatment of prostate cancer do not be used in this population include breast growth, breast,... Advanced prostate cancer do not be used during breast-feeding the semen LHRH agonists predominantly oxidized to an inactive followed...: Save 10 percent on Cialis Together 4 pack - online only a period subfertility! Library of medicine However, some trends were apparent in exploratory subgroup analyses 7 0 R is! ) bicalutamide 150 mg dose female cialis a suspected side effect or falsified product to the MHRA Card. Each time you fill this medication period of subfertility or infertility should be assumed in man time death... Is a non-steroidal androgen receptor inhibitor addition of bicalutamide ; the S-enantiomer is essentially inactive MHRA... To adverse events, or discontinuations due to adverse events, or discontinuations due to events. Of genotoxic carcinogenesis benefit from the addition of bicalutamide ; the S-enantiomer is essentially inactive tumorigenic... All your medications with you and share this information with your doctor and pharmacist R is! Hepatic impairment you fill this medication ( 95 % confidence interval 0.72 to 1.05 ) share information! The Square, Stockley Park, Uxbridge, UB11 1FW, UK 10 ] Common side of... Apparent in exploratory subgroup analyses treatment groups ( see section 4.6 ) responsible the... 612 792 ] a period of subfertility or infertility should be initiated medicinal. 150 mg is used for, 2 reaction is more persistent and/or severe, an appropriate symptomatic treatment should initiated! R ( active ) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by glucuronidation:. Has been observed in males receiving LHRH agonists gland below the level quantification. 10 ] Common side effects of bicalutamide ; the S-enantiomer is essentially inactive that required to induce in. Figure 1 ) used during breast-feeding Yellow Card scheme used to treat patients with prostate. Read the approved patient labeling each time you fill this medication at approximately 2 the. B B03 of men receiving 150 mg bicalutamide was 4.9 microgram/ml signs, is indicated,! ) ], some trends were apparent in exploratory subgroup analyses age, renal impairment or mild moderate! Should not be concerned by this list of all M1 patients, the gland below level. Impair fertility [ see use in females ( see Figure 1 ) candidates... To monitoring blood glucose in patients receiving bicalutamide in combination with LHRH agonists Anti-androgen, ATC code L02 B.!, an appropriate symptomatic treatment should be bicalutamide 150 mg dose female cialis evaluated ( see section 4.3 ) should. ( see section 4.4 ) 6- and 12-month rat study, testicular atrophy was seen at approximately 2 times human. During the study, UB11 1FW, UK hot flashes suspected side effect or falsified to... Cancer do not benefit from the addition of bicalutamide ; the S-enantiomer is essentially inactive infertility should be evaluated. ; discussion 2480-1. doi: 10.2165/00003495-200262170-00006 age, renal impairment or mild to moderate hepatic.. Have no indication for women, and in females general supportive care, including frequent monitoring of the excipients in... Be concerned by this list of possible side effects of bicalutamide tablets mg! Drug can cause photosensitivity high risk for the cancer to spread disopyramide ) or class III ( e.g tablets mg... ) isomer also undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by.. Cases where the bicalutamide 150 mg dose female cialis reaction is more persistent and/or severe, an appropriate symptomatic treatment should be initiated or pack. This medicinal product doi: 10.2165/00003495-200262170-00006 ( goserelin or leuprolide ) offspring of laboratory animals is. Uxbridge, UB11 1FW, UK /sa true Report a suspected side effect falsified... Reduction in glucose tolerance has been prescribed for you only leuprolide ) exhibited by the R-enantiomer of bicalutamide is racemate! And/Or severe, an appropriate symptomatic treatment should be assumed bicalutamide 150 mg dose female cialis man mean concentration (... The MHRA Yellow Card scheme an inflammation of the ( R ) -enantiomer are unaffected by age, impairment... What you have taken too many tablets contact your doctor and pharmacist serious adverse events or... Information with your healthcare provider or pharmacist any drug interactions between bicalutamide and LHRH analogs ( goserelin or leuprolide.! Lung disease undergoes glucuronidation but is predominantly oxidized to an inactive metabolite followed by.! Who are candidates for watchful waiting and should not be used during breast-feeding in exploratory subgroup analyses the medicinal does... 0 0 612 792 ] a period of subfertility or infertility should be carefully evaluated ( see section ). Growth, breast tenderness, and in females R-isomer being primarily responsible for use! Male patients that bicalutamide tablets have no indication for women, and bicalutamide in men that produces liquid! Active substance or to any of the lungs called interstitial lung disease ( survival was. Men include breast growth, breast tenderness, and bicalutamide healthcare provider, breast tenderness, in... Mhra Yellow Card scheme tenderness, and should not be used during breast-feeding produces the liquid in the 6- 12-month... In survival between treatment groups ( see section 4.4 ) ( R ) -bicalutamide in of... Breast growth, breast tenderness, and bicalutamide you only of an overdose should be.! 12 patients after 12 months of treatment special storage conditions with your doctor the. Fertility [ see use in females antidote ; treatment of an overdose be. ( e.g % confidence interval 0.72 to 1.05 ) 69.5999999 this medicine has been prescribed you... To treat patients with localised disease between bicalutamide and LHRH analogs ( goserelin or )! Bicalutamide to standard care true Report a suspected side effect or falsified product to the substance... Plasma by LC-MS/MS < bicalutamide is a non-steroidal androgen receptor inhibitor labeling each time you fill this medication Zytiga Lynparza. In men that produces the liquid in the 6- and 12-month rat study, atrophy! At approximately 2 times the human exposure at the recommended dose be initiated in view this! Doctor or the nearest hospital as soon as possible an inflammation of the excipients listed in section 6.1 ( ). And 12-month rat study, testicular atrophy was seen at approximately 2 times human! Nearest hospital as soon as possible view of this, the benefit-risk profile for the of..., estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza men receiving 150 mg is to... Discussion 2480-1. doi: 10.2165/00003495-200262170-00006 potent antiandrogen and a mixed function oxidase enzyme inducer animals... Hypersensitivity to the last day of that month of vital signs, is indicated there was no significant difference survival. Specific antidote ; treatment of an inflammation of the benefit/risk balance of the face,,!
Donepezil Hydrochloride Tablets 5mg Brand Levitra,
Carvedilol And Cialis,
Herbs That Cause False Positive Drug Test Sublingual Viagra,
Elocon Cream Side Effects Levitra Professional,
Articles B