Firma Chun Cheong
Concise Prescribing Info
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination w/ androgen deprivation therapy in adult men. High-risk non-metastatic castration-resistant prostate cancer (CRPC) in adult men. Metastatic CRPC in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. Metastatic CRPC in adult men whose disease has progressed on or after docetaxel therapy.
Dosage/Direction for Use
160 mg (four 40-mg cap) as a single oral daily dose.
May be taken with or without food: Swallow whole, do not chew/dissolve/open
Special Precautions
Hypersensitivity reactions. Reports of severe cutaneous adverse reactions. Associated w/ seizure. Discontinue in patients who develop posterior reversible encephalopathy syndrome. Reports of 2nd primary malignancies. Promptly seek attention if signs of GI bleeding, macroscopic haematuria, dysuria or urinary urgency develop during treatment. Patients w/ recent CV disease. May prolong QT interval. Avoid co-administration w/ medicinal products that are sensitive substrates of many metabolising enzymes or transporters; warfarin & coumarin-like anticoagulants; strong CYP2C8 inhibitors. Concomitant use w/ cytotoxic chemotherapy. Possible increase in occurrence of docetaxel-induced neutropenia. Should not be taken by patients w/ rare hereditary problems of fructose intolerance. May have moderate influence on the ability to drive & use machines. Patients w/ severe hepatic impairment; severe renal impairment or ESRD. Use contraception during & for 3 mth after treatment if engaging in sexual activity w/ pregnant woman or woman of childbearing potential. Not for use in women. No relevant use in paed population.
Adverse Reactions
Hot flush, HTN; fractures; asthenia, fatigue; fall. Anxiety; headache, memory impairment, amnesia, disturbance in attention, dysgeusia, restless legs syndrome; ischemic heart disease; dry skin, pruritus; gynaecomastia.
Drug Interactions
Increased AUC w/ strong CYP2C8 inhibitors (eg, gemfibrozil). Potential loss or reduction of clinical effect or increased risk of active metabolite formation of analgesics (eg, fentanyl, tramadol); antibiotics (eg, clarithromycin, doxycycline); anticancer agents (eg, cabazitaxel); antiepileptics (eg, carbamazepine, clonazepam, phenytoin, primidone, valproic acid); antipsychotics (eg, haloperidol); antithrombotics (eg, acenocoumarol, warfarin, clopidogrel); β-blockers (eg, bisoprolol, propranolol); Ca channel blockers (eg, diltiazem, felodipine, nicardipine, nifedipine, verapamil); cardiac glycosides (eg, digoxin); corticosteroids (eg, dexamethasone, prednisolone); HIV antivirals (eg, indinavir, ritonavir); hypnotics (eg, diazepam, midazolam, zolpidem); immunosuppressants (eg, tacrolimus); PPIs (eg, omeprazole); statins metabolised by CYP3A4 (eg, atorvastatin, simvastatin); thyroid agents (eg, levothyroxine). Caution w/ concomitant use of P-gp substrates w/ narrow therapeutic range (eg, colchicine, dabigatran etexilate, digoxin). Additive effect w/ medicinal products known to prolong QT interval (eg, quinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide, methadone, moxifloxacin, antipsychotics).
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB04 - enzalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Xtandi cap 40 mg
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