Concise Prescribing Info
Listed in Dosage.
Dosage/Direction for Use
Adult: PO Palliation of advanced prostate cancer 50 mg once daily, w/ gonadotropin-releasing hormone (GnRH) agonist or surgical castration. Monotherapy or adjuvant therapy to surgery or radiotherapy in locally advanced prostatic cancer 150 mg once daily.
May be taken with or without food.
Females, childn. Pregnancy and lactation. Concomitant use of terfenadine, astemizole or cisapride.
Special Precautions
Patient w/ decreased bone density, history of or risk factors for QT prolongation, diabetes, Moderate to severe hepatic and severe renal impairment (CrCl <30 mL/min). Patient CounsellingThis drug may cause somnolence, if affected, do not drive or operate machinery. Monitoring Parameters Perform LFT at baseline and regularly (particularly during the 1st 6 mth of therapy), then periodically thereafter. Monitor CBC, ECG, echocardiograms, serum testosterones, LH and serum prostate specific antigen.
Adverse Reactions
Anaemia; angioedema, urticaria; decreased appetite, DM, wt gain, dehydration, gout; decreased libido, depression, anxiety, hypertonia, confusion, neuropathy, nervousness, dizziness, somnolence; hot flush; abdominal pain, constipation, nausea, dyspepsia, flatulence, anorexia, rectal haemorrhage, dry mouth, melaena; hepatotoxicity, jaundice, hypertransaminasaemia; alopecia, hirsutism, dry skin, pruritus/rash, photosensitivity; haematuria, dysuria, urinary retention, impaired urination, urinary frequency; gynaecomastia, breast tenderness, erectile dysfunction; asthenia, oedema, chest pain, neck pain, fever, sepsis, chills, neoplasm; cough, pharyngitis, bronchitis, pneumonia, rhinitis.
Potentially Fatal: MI, cardiac failure, QT prolongation, interstitial lung disease, hepatic failure.
Drug Interactions
May induce torsade de pointes or QT prolongation if co-administered w/ class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmic agents, methadone, antipsychotics, moxifloxacin. Enhanced anticoagulant effect of warfarin. Increased adverse effects when used w/ drugs that may inhibit oxidation (e.g. cimetidine, ketoconazole). May increase serum levels of ciclosporin and Ca channel blockers.
ATC Classification
L02BB03 - bicalutamide ; Belongs to the class of anti-androgens.
Disclaimer: This information is independently developed by CIMS based on bicalutamide from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in