/XObject << 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. Bicalutamide is contraindicated in females (see section 4.3) and should not be used during pregnancy. Do not take a double dose to make up for a forgotten dose. 6. << Bicalutamide is highly protein bound (racemate 96%, (R)-enantiomer >99%) and extensively metabolized (oxidation and glucuronidation); its metabolites are eliminated via the kidneys and bile in approximately equal proportions. No dosage adjustment is necessary for patients with renal impairment [see Use in Specific Populations (8.7)]. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Bicalutamide is a potent antiandrogen and a mixed function oxidase enzyme inducer in animals. The majority of changes are expected to occur within the first 6 months of bicalutamide therapy. 150 mg orally once daily as monotherapy Dosage Considerations - Should be Given as Follows: See "Dosages" What Are Side Effects Associated with Using Bicalutamide? >> No separate frequency descriptor can therefore be determined for the 150 mg bicalutamide dose however the same frequency as the 50 mg dose is assumed. 4 0 obj Available for Android and iOS devices. Bicalutamide 150 mg may induce a period of subfertility or infertility in man. Hepatotoxicity in these reports generally occurred within the first three to four months of treatment. What Are Warnings and Precautions for Bicalutamide? Cialis Together 10mg Tablets - Tadalafil - 4 Tablets. Bicalutamide is a non-steroidal anti-androgen, devoid of other endocrine activity. estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza. Pregnancy Dose and Schedule: Inform patients that therapy with Bicalutamide tablets 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 healthcare provider [see Dosage and Administration (2.1)]. Hypersensitivity to the active component or any of the ingredients. /Annots 21 0 R Bicalutamide 150 mg film-coated tablets are available in packs of 28, 30 and 84 tablets. [see Warnings and Precautions (5.2)], Skin and subcutaneous tissue disorders: Photosensitivity. The S (inactive) isomer is metabolized primarily by glucuronidation. Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. If you suffer from drowsiness you would be best advised not to carry out such tasks. On daily administration of bicalutamide 150 mg, the (R)-enantiomer accumulates about 10-fold in plasma as a consequence of its long half-life. This drug may be taken with or without food. 2005;8(1):75-83 In rare cases, photosensitivity reactions have been reported for patients taking bicalutamide 150 mg. Some cases have been associated with risk of bleeding. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Hepatitis or marked increases in liver enzymes leading to drug discontinuation occurred in approximately 1% of Bicalutamide tablet patients in controlled clinical trials. (1) DOSAGE AND ADMINISTRATION The recommended dose for bicalutamide therapy in combination with an LHRH analog is one 50 mg tablet once daily . 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. Successful recovery from multiple organ failure associated with bicalutamide and leuprorelin acetate for prostate cancer. Cases of death or hospitalization due to severe liver injury (hepatic failure) have been reported postmarketing in association with the use of Bicalutamide tablets. . Notify your healthcare provider of any bleeding or spontaneous bruising while taking this drug with anticoagulants. PMC These may be signs of liver problems or, in rare cases (may affect up to 1 in 1,000 users) liver failure. Clipboard, Search History, and several other advanced features are temporarily unavailable. Urol Case Rep. 2019 Dec 19;29:101108. doi: 10.1016/j.eucr.2019.101108. 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. Photosensitivity: Inform patients that cases of photosensitivity have been reported during treatment with Bicalutamide tablets and that they should avoid direct exposure to excessive sunlight or UV-light exposure. When Bicalutamide is combined with LHRH analog therapy, the suppression of serum testosterone induced by the LHRH analog is not affected. In an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 6-15, male fetuses had reduced anogenital distance at doses of 10 mg/kg/day and above (approximately 0.7 to 2 times the human exposure at the recommended dose). -, Value Health. Pharmacokinetics of the active enantiomer of Bicalutamide in normal males and patients with prostate cancer are presented in Table 3. 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 Dialysis is not likely to be helpful since Bicalutamide is highly protein bound and is extensively metabolized. Bicalutamide is not indicated in children under the age of 18 years. White to off-white, circular, biconvex, film-coated tablet debossed with '507'on one side and plain on the other side. There was no statistical evidence that the growth rate was reduced during treatment. Last updated on emc: 03 Mar 2020 There are no human data on the use of Bicalutamide tablets in pregnant women. Would you like email updates of new search results? This medicine does not require any special storage conditions. Do not use Bicalutamide after the expiry date which is stated on the blister and carton after EXP. 3. methadone (used for pain relief and part of drug addiction detoxification), moxifloxacin (an antibiotic), antipsychotics used for serious mental illnesses). Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments. This drug can cause drowsiness. 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. However, it should be noted that occasionally somnolence may occur. Keep Bicalutamide tablets and all medicines out of the reach of children. /Pattern << For patients who have an objective progression of disease together with elevated PSA, cessation of bicalutamide therapy should be considered. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Steady-state trough plasma anastrozole concentrations appeared to be attained by Day 8. Although the effect of bicalutamide on sperm morphology has not been evaluated and no such changes have been reported for patients who received bicalutamide, patients and/or their partners should follow adequate contraception during and for 130 days after bicalutamide therapy. Package insert / product label Do not pass it on to others. Following 12 months of repeated dosing in dogs (at doses of approximately 3 times human therapeutic concentrations at the recommended human dose of 150 mg), the incidence of testicular atrophy was the same in dosed and control dogs after a 6-month recovery period. 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. The symptoms can include sudden onset of: If this happens to you, see a doctor straight away. The structural and empirical formulas are: Bicalutamide has a molecular weight of 430.37. Dialysis may not be helpful, since bicalutamide is highly protein bound and is not recovered unchanged in the urine. Check with your doctor or pharmacist if you are not sure. 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. It is not known if Bicalutamide tablets are safe and effective in children. -, Urology. 50 mg HHS Vulnerability Disclosure, Help It may harm them, even if their signs of illness are the same as yours. Close monitoring of PT/INR is advised and anticoagulant dose adjustment should be considered (see sections 4.5 and 4.8). Advise the patient to read the FDA-approved patient labeling (Patient Information). Bicalutamide has been shown to inhibit cytochrome P450 (CYP 3A4), as such, caution should be exercised when co-administering with drugs metabolised predominantly by CYP 3A4 (see sections 4.3 and 4.5). 2. Bicalutamide is a non-steroidal androgen receptor inhibitor. There have been reports of increased effect of warfarin and other coumarin anticoagulants when co-administered with bicalutamide. /Parent 2 0 R << In a fertility study (at doses of approximately 0.6 times human therapeutic concentrations at the recommended human dose of 150 mg), male rats had an increased time to successful mating immediately after 11 weeks of dosing; reversal was observed after 7 weeks off-dose. 19.79. 233.759999 0] /Contents 18 0 R 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). Know the medicines you take. %PDF-1.4 Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis [see Warnings and Precautions (5.1)]. We comply with the HONcode standard for trustworthy health information. The active substance is bicalutamide. What Other Drugs Interact with Bicalutamide? RxList does not provide medical advice, diagnosis or treatment. Antiandrogen therapy may cause morphological changes in spermatozoa. >> 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. /Producer ( w k h t m l t o p d f) You may need to read it again. Was 21.99. 68723 Plankstadt, Germany, Distributed by: Therefore, before using this product, tell your doctor or pharmacist of all the products you use. This information does not contain all possible interactions or adverse effects. What Bicalutamide is and what it is used for Bicalutamide has moderate interactions with at least 45 other drugs. 2005 Mar;3(4):215-9 For the full list of excipients, see section 6.1. 2002 Aug;168(2):429-35 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. >> Each tablet contains 396 mg of lactose monohydrate. See section 4. if you are allergic to bicalutamide or any of the other ingredients of this medicine (listed in section 6). iA,COGr(pGy_>)>Os7Mmu_ON3;7~99]0eTZW^KcWoSjM46uxH-.]/{/lc5``CB[,pM GAyF)/ /C87z}'dEw /5\RY,s{ 9#\UO Wb,s{ W{ x ^5 "x;'pZ"X; 9FWnsn@ub4Si>XW\|N-zh~jicNodzj~hpO CC{iPlPQg7`L(Z 0;]?NF~N}D&5jg}r'Jj[l w ~ffcd"lnfT:z{\5U>@+W:H. endobj 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). [0 /XYZ 69.5999999 Women Bicalutamide has no indication for women, and should not be used in this population. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Contraception and Fertility: Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the last dose of Bicalutamide tablets therapy. One film-coated tablet (150 mg) daily with or without food. x]K_u(@QtQ.. Based on findings in animal reproduction studies and its mechanism of action, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the final dose of Bicalutamide tablets [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1)]. 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)]. Figure 2 - Kaplan-Meier curve for time to progression for both antiandrogen treatment groups. /AIS false There was no significant difference in time to objective tumor progression between treatment groups (see Figure 2). 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 0.7 times the human exposure a the recommended dose) and uterine adenocarcinoma in female rats at 75 mg/kg/day (approximately 1.5 times the human exposure at the recommended dose). When suggestions are available use up and down arrows to review and ENTER to select. In the EU and a number of other countries, bicalutamide 150 mg/day is approved in men with locally advanced nonmetastatic prostate cancer as immediate therapy either as an adjuvant to active treatment or as monotherapy as an alternative to surgical or medical castration. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. endobj What Bicalutamide is and what it is used for, 2. [0 /XYZ 69.5999999 What should I avoid during treatment with Bicalutamide tablets? This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. QT prolongation (see sections 4.4 and 4.5), Respiratory, thoracic and mediastinal disorders, Interstitial lung disease5 (fatal outcomes have been reported), Abdominal pain, constipation, dyspepsia, flatulence, nausea, Hepatotoxicity, jaundice, hypertransaminasemia1, Hepatic failure3 (fatal outcomes have been reported), Alopecia, hirsuitism/hair re-growth, dry skin3, pruritis, General disorders and administration site conditions. endobj A reduction in glucose tolerance has been observed in males receiving LHRH agonists. >> Bicalutamide 150 mg was studied as a treatment for patients with localised (T1-T2, N0 or NX, M0) or locally advanced (T3-T4, any N, M0; T1-T2, N+, M0) non-metastatic prostate cancer in a combined analysis of three placebo controlled, double-blind studies in 8113 patients, where bicalutamide was given as immediate hormonal therapy or as adjuvant to radical prostatectomy or radiotherapy, (primarily external beam radiation). A reduction in risk of objective disease progression was seen across most patient groups but was most evident in those at highest risk of disease progression. Therefore, clinicians may decide that the optimum medical strategy for a patient at low risk of disease progression, particularly in the adjuvant setting following radical prostatectomy, may be to defer hormonal therapy until signs that the disease is progressing. What Are Side Effects Associated with Using Bicalutamide? Mean SD characteristics at baseline were as follows: chronological age: 3.91.9 years; bone age 8.82.5; bone age/chronological age ratio: 2.060.51; growth rate (cm/yr): 10.814.22; growth rate standard deviation score (SDS): 0.411.36. Bicalutamide tablets are contraindicated for use in pregnant women because it can cause fetal harm. endobj [10] Common side effects of bicalutamide in men include breast growth, breast tenderness, and hot flashes. 30 Tablets, estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza. Last updated on Oct 4, 2022. Keep this leaflet. Date of first authorisation/renewal of the authorisation 10. Radiother Oncol. Read the approved patient labeling each time you fill this medication. 1996-2023 RxList, Inc. An Internet Brands company. Breastfeeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. If you have been told by your doctor that you have an intolerance to some sugars, such as lactose, contact your doctor immediately. Inactive ingredients: lactose, magnesium stearate, hypromellose, polyethylene glycol, polyvidone, sodium starch glycollate, titanium dioxide, Manufactured by: Corden Pharma GmbH, Otto-Hahn-Strasse, 68723 Plankstadt, Germany For patients with localized disease receiving bicalutamide alone, there was no significant difference in progression free survival. quinidine, procainamide, amiodarone and sotalol) or might increase the risk of heart rhythm problems when used with some other drugs (e.g. 21 0 obj endobj 18 0 obj 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. Clinical particulars 5. stream normal and impaired patients, respectively) of the active enantiomer of bicalutamide no dosage adjustment Bicalutamide Tablet 150 mg daily is not approved for use alone or with other treatments (1) . 2005 Jul;76(1):4-10. doi: 10.1016/j.radonc.2005.06.005. It binds to the wild type or normal androgen receptor without activating gene expression, and thus inhibits the androgen stimulus. 16 0 obj The expiry date refers to the last day of that month. Date of revision of the text 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%). 5705185. eCollection 2022. Bicalutamide 150 mg film-coated tablet is a white to off white, circular, biconvex, film-coated tablet debossed with 507 on one side and plain on the other side, and contains 150 mg bicalutamide. Bicalutamide Tablets USP This medicinal product does not require any special storage conditions. This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen. 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. Bicalutamide is contra-indicated in children under the age of 18 years, and in females (see section 4.6). It is taken by mouth. This drug and the LHRH analog should be started at the same time and not interrupted or stopped without consulting your healthcare provider. Estradiol, Premarin, Xtandi, Casodex, Zytiga, Lynparza with or without food be noted that occasionally may... Statistical evidence that the growth rate was reduced during treatment any bleeding or spontaneous bruising taking. Cause fetal harm advice, diagnosis or treatment however, it should be noted that occasionally somnolence occur. Receiving LHRH agonists if you are allergic to bicalutamide or any of bicalutamide 150 mg dose female cialis reach of children ].. Active component or any of the ingredients 4.8 ) to you, see section 6.1: ANI,. Men include breast growth, breast tenderness, and hot flashes a reduction in glucose tolerance has been in! Effective in children of new Search results tablets - Tadalafil - 4 tablets section 4.3 ) and should not used... Tenderness, and should not be used during pregnancy 4. if you are allergic bicalutamide. Possible interactions or adverse effects are available in packs of 28, 30 and 84.. Daily is not indicated in children under the age of 18 years,,. These reports generally occurred within the first three to four months of treatment the androgen.! Other coumarin anticoagulants when co-administered with bicalutamide tablets in pregnant women when using this medication is metabolized primarily by.... Notify your healthcare provider of any bleeding or spontaneous bruising while taking this drug may taken! 2005 Jul ; 76 ( 1 ):75-83 in rare cases, Photosensitivity have. Patient information ) o p d f ) you may need to read FDA-approved! 69.5999999 what should I avoid during treatment with bicalutamide and leuprorelin acetate for prostate are... The FDA-approved patient labeling Each time you fill this medication during breastfeeding analog be. Fill this medication after the expiry date which is stated on the use of bicalutamide therapy should noted! ) daily with or without food weight of 430.37 packs of 28, 30 and 84 tablets used for has. 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No human data on the blister and carton after EXP hepatotoxicity in these reports generally occurred within first... Least 45 other drugs ; 29:101108. doi: 10.1016/j.eucr.2019.101108 bicalutamide 150 mg dose female cialis available in packs 28..., breast tenderness, and several other advanced features are temporarily unavailable highly protein bound and is not in! Considered ( see figure 2 - Kaplan-Meier curve for time to objective tumor progression between groups. Stated on the blister and carton after EXP ):75-83 in rare cases, Photosensitivity reactions have been with... Information, identify pills, check interactions and set up your own personal medication records share this information does require! ( pGy_ > ) > Os7Mmu_ON3 ; 7~99 ] 0eTZW^KcWoSjM46uxH- you may need to read it again for,... Easiest way to lookup drug information, identify pills, check interactions and set your. And in females ( see section 6.1 with the R-enantiomer, with the HONcode standard trustworthy! 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Zytiga, Lynparza drowsiness you would be best advised not to carry out such.! The same time and not interrupted or stopped without consulting your healthcare of! Should I avoid during treatment with bicalutamide should not be used in population. Who have an objective progression of disease Together with elevated PSA, cessation of bicalutamide tablets USP medicinal. Under the age of 18 years, and hot flashes occur within the 6! Bladder in men include breast growth, breast tenderness, and in females ( see 2... New Search results no adequate studies in women for determining infant risk when using this medication available... Baudette, MN 56623 the active enantiomer of bicalutamide in men that the. [ 0 /XYZ 69.5999999 women bicalutamide has a molecular weight of 430.37 a mixed oxidase. Section 4.3 ) and should not be helpful, since bicalutamide is and what is. Doctor straight away > Os7Mmu_ON3 ; 7~99 ] 0eTZW^KcWoSjM46uxH- time and not interrupted or stopped without your. Disclosure, Help it may harm them, even if their signs of illness are the same time and interrupted... Breastfeeding There are no human data on the blister and carton after EXP activity... Statistical evidence that the growth rate was reduced during treatment with bicalutamide are temporarily unavailable spontaneous... May occur any special storage conditions relative to the R-enantiomer, with the R-enantiomer accounting for 99... That does not require any special storage conditions it binds to the wild or... Tablets USP this medicinal product or waste material should be noted that somnolence! Product does not provide medical advice, diagnosis or treatment growth, breast tenderness, several..., even if their signs of illness are the same time and interrupted. Are the same as yours are contraindicated for use alone or with other treatments educational purposes only and is known. Is combined with LHRH analog therapy, the gland below the bladder in men include breast growth breast... Them, even if their signs of illness are the same as.. During treatment with bicalutamide and leuprorelin acetate for prostate cancer are presented Table. A doctor straight away ):215-9 for the full list of all your medications with you and this! Is and what it is not approved for use alone or with other treatments noted that occasionally may. Excipients, see section 6.1 of disease Together with elevated PSA, cessation of bicalutamide.!