Xtandi

Xtandi

enzalutamide

Manufacturer:

Astellas

Distributor:

Firma Chun Cheong
/
DKSH
Concise Prescribing Info
Contents
Enzalutamide
Indications/Uses
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.
Administration
May be taken with or without food: Swallow whole, do not chew/dissolve/open
Contraindications
Special Precautions
Hypersensitivity reactions. Associated w/ seizure. Posterior reversible encephalopathy syndrome. Recent CV disease. May prolong QT interval. Potent enzyme inducer. Concomitant use w/ anticoagulants (eg, warfarin or acenocoumarol); chemotherapy; strong CYP2C8 inhibitors. Severe renal & hepatic impairment. Rare hereditary problems of fructose intolerance. Use contraception during & for 3 mth after treatment if patient is engaged in sexual activity w/ pregnant woman or woman of childbearing potential. Not for use in women. Moderate influence on the ability to drive & use machines.
Adverse Reactions
Asthenia/fatigue; hot flush, HTN; fractures. Anxiety; headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome; ischemic heart disease; gynaecomastia; dry skin, pruritus; fall.
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); proton pump inhibitor (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, ibutulide, methadone, moxifloxacin, antipsychotics).
ATC Classification
L02BB04 - enzalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Xtandi cap 40 mg
Packing/Price
112's
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