Bicalutamide


Generic Medicine Info
Administration
May be taken with or without food.
Contraindications
Females. Children. Pregnancy and lactation. Concomitant use of terfenadine, astemizole, or cisapride.
Special Precautions
Patient with history of or risk factors for QT prolongation, heart failure, frequent electrolyte abnormalities; alcohol abuse, family history or risk factors for osteoporosis; diabetes. Moderate to severe hepatic impairment. Patient Counselling Avoid excessive exposure to sunlight or UV light and utilise adequate sun protection (e.g. wear protective clothing, use of sunscreen). Monitoring Parameters Monitor LFT at baseline and regularly during the 1st 4 months of therapy, then periodically thereafter; CBC, electrolyte, ECG, echocardiograms, LH, prostate specific antigen, serum testosterone periodically; blood glucose (in diabetic patients), PT and INR (in patients receiving warfarin). Monitor for signs and symptoms of liver dysfunction.
Adverse Reactions
Significant: QT prolongation, gynaecomastia, breast pain, anaemia, hepatitis, increased liver enzymes, hypersensitivity reactions (e.g. angioneurotic oedema, urticaria); decreased bone mineral density (prolonged use); loss of glycaemic control and decreased glucose tolerance (in combination with LHRH agonists in diabetic patients). Rarely, photosensitivity reactions. Cardiac disorders: Cardiac failure, chest pain. Gastrointestinal disorders: Abdominal pain, constipation, nausea, dyspepsia, flatulence, diarrhoea. General disorders and administration site conditions: Asthenia. Investigations: Increased weight. Metabolism and nutrition disorders: Decreased appetite, oedema. Nervous system disorders: Dizziness, somnolence. Psychiatric disorders: Depression. Renal and urinary disorders: Haematuria. Reproductive system and breast disorders: Erectile dysfunction, decreased libido. Skin and subcutaneous tissue disorders: Dry skin, alopecia, hirsutism or hair regrowth, pruritus, rash. Vascular disorders: Hot flush.
Potentially Fatal: Severe liver injury. Rarely, interstitial lung disease.
Drug Interactions
Increased risk of haemorrhage with anticoagulants e.g. coumarin. Increased risk of QT interval prolongation or torsade de pointes with class IA (e.g. quinidine, disopyramide) or class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic drugs, methadone, moxifloxacin, or antipsychotics. May increase serum levels of ciclosporin and Ca channel blockers.
CIMS Class
Hormonal Chemotherapy
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 © 2022 CIMS. All rights reserved. Powered by CIMSAsia.com
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