Adult: In combination with LH-releasing hormone (LHRH) agonist, as initial or as adjunctive treatment in patients already receiving LHRH agonist or in surgically castrated patients: 250 mg 8 hourly, started at the same time or ≥24 hours before the LHRH agonist. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
Oral Metastatic prostate cancer
Adult: In combination with an LHRH agonist for locally confined Stage B2 to C cases: 250 mg 8 hourly, started 8 weeks before radiation therapy and continued during radiation therapy. In combination with an LHRH agonist for Stage D2 cases: 250 mg 8 hourly, continue until disease progression. Treatment recommendations may vary among individual products and between countries (refer to specific product guidelines).
What are the brands available for Flutamide in Hong Kong?
Apo-Flutamide
Fluta-cell 250
Hepatic Impairment
Severe: Contraindicated.
Administration
Flutamide May be taken with or without food.
Contraindications
Severe hepatic impairment, serum transaminase levels >2-3 times the ULN.
Special Precautions
Patient with CV disease; history of or risk factors for QT prolongation and those receiving drugs that may prolong QT interval; risk factors for aniline toxicity (e.g. G6PD deficiency, haemoglobin M disease, smokers); diabetes. Not indicated for use in women. Renal and mild to moderate hepatic impairment.
Adverse Reactions
Significant: Elevated serum transaminase levels, hepatic necrosis, hepatic encephalopathy; aniline toxicity (e.g. haemolytic anaemia, methaemoglobinaemia, cholestatic jaundice); elevated plasma testosterone and estradiol levels which may lead to fluid retention; gynaecomastia, decreased glucose tolerance; reduced BMD and increased risk of osteoporotic fractures; interstitial pneumonitis. Gastrointestinal disorders: Nausea, vomiting, diarrhoea. General disorders and administration site conditions: Tiredness, asthenia. Metabolism and nutrition disorders: Increased appetite. Nervous system disorders: Drowsiness, somnolence. Psychiatric disorders: Insomnia. Renal and urinary disorders: Amber or yellow-green urine discolouration. Reproductive system and breast disorders: Breast pain and tenderness, galactorrhoea, impotence, decreased libido. Vascular disorders: Hot flushes, hypertension. Potentially Fatal: Hepatotoxicity, liver failure.
This drug may cause dizziness and confusion, if affected, do not drive or operate machinery. Men with female partners of childbearing potential must use effective contraception during therapy.
Monitoring Parameters
Monitor serum transaminase levels at baseline, monthly during the 1st 4 months, and periodically thereafter; ECG at baseline and regularly during treatment (particularly in patients at risk of QT prolongation); BMD at baseline and regularly as indicated (particularly in patients at higher risk for fractures); PSA. Monitor for respiratory symptoms during the 1st few weeks of treatment. Assess for signs and symptoms of liver failure (e.g. jaundice, dark urine, severe abdominal pain, loss of appetite).
Overdosage
Symptoms: Gynaecomastia, breast sensitivity, increased AST, cyanosis. Management: Supportive treatment. Induce vomiting if it has not occurred spontaneously and if the patient is alert. May consider gastric lavage. Frequently monitor vital signs and observe closely.
Drug Interactions
Increased risk of QT prolongation and torsades de pointes with class Ia (e.g. disopyramide, quinidine) or class III (e.g. sotalol, dofetilide, ibutilide, amiodarone) antiarrhythmics, antipsychotics (e.g. chlorpromazine), opioids (e.g. methadone), macrolide antibiotics (e.g. erythromycin, clarithromycin, azithromycin), quinolone antibiotics (e.g. moxifloxacin), antimalarials (e.g. quinine), beta-2 adrenoceptor agonists (e.g. salbutamol). Increased prothrombin time with oral anticoagulants (e.g. warfarin). May increase plasma concentrations of theophylline.
Food Interaction
Increased risk of toxicities with alcohol.
Action
Description: Mechanism of Action: Flutamide is a nonsteroidal antiandrogen which acts by inhibiting the uptake and/or binding of androgens in the target tissues. This action results in growth arrest or transient tumour regression through inhibition of androgen-dependent DNA and protein synthesis. Pharmacokinetics: Absorption: Rapidly and completely absorbed from the gastrointestinal tract. Time to peak plasma concentration: Approx 2 hours (2-hydroxyflutamide). Distribution: Plasma protein binding: 94-96% (flutamide); 92-94% (2-hydroxyflutamide). Metabolism: Rapidly and extensively metabolised in the liver mainly into 2-hydroxyflutamide (major active metabolite) and other metabolites. Excretion: Mainly via urine (as flutamide and metabolites); faeces (approx 4%). Elimination half-life: Approx 6 hours (2-hydroxyflutamide).
Chemical Structure
Flutamide Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3397, Flutamide. https://pubchem.ncbi.nlm.nih.gov/compound/Flutamide. Accessed July 28, 2025.
Storage
Store between 20-25°C. Protect from light. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal.
L02BB01 - flutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
References
Brayfield A, Cadart C (eds). Flutamide. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/06/2025.Eulexin Capsule (Waylis Therapeutics LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 10/06/2025.Eumide Tablet 250 mg (Duopharma [M] Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 10/06/2025.Flutamide 250 mg Tablets (Generics [UK] Limited t/a Mylan). MHRA. https://products.mhra.gov.uk. Accessed 10/06/2025.Flutamide. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/06/2025.Flutamide. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 10/06/2025.Joint Formulary Committee. Flutamide. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 10/06/2025.Viatris Ltd. Flutamin 250 mg Tablet data sheet 7 November 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 10/06/2025.
Sign Out
Continue with Google