Concise Prescribing Info
Adult men w/ non-metastatic castration-resistant prostate cancer (CRPC); metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; metastatic castration-resistant prostate cancer 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 w/ water, do not chew/dissolve/open.
Hypersensitivity. Pregnant women or who may become pregnant.
Special Precautions
Permanently discontinue in patients who develop seizure during therapy. Discontinue in patients who develop posterior reversible encephalopathy syndrome (PRES). Avoid in concomitant w/ drugs that are sensitive substrates of many metabolising enzymes or transporters; warfarin & coumarin-like anticoagulants; cytotoxic chemotherapy. Patients w/ recent MI (in the past 6 mth) or unstable angina (in the past 3 mth), NYHA III or IV heart failure except if left ventricular ejection fraction ≥45%, bradycardia or uncontrolled HTN. Fructose intolerance. Hypersensitivity reactions. Severe renal impairment or end-stage renal disease. Severe hepatic impairment. May impair ability to drive or operate machinery. Not for use in women & childn.
Adverse Reactions
Asthenia/fatigue; hot flush, HTN; fractures. Ischemic heart disease; anxiety; headache, memory impairment, amnesia, disturbance in attention, restless legs syndrome; gynaecomastia; dry skin, pruritus; fall.
Drug Interactions
Increased AUC & decreased Cmax w/ strong CYP2C8 inhibitor eg, gemfibrozil. May decrease AUC of midazolam, S-warfarin & omeprazole. Risk of liver injury w/ paracetamol. Potential to affect exposures 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), immunosuppressant (eg, tacrolimus), proton pump inhibitor (eg,omeprazole), statins metabolized by CYP3A4 (eg, atorvastatin, simvastatin), thyroid agents (eg, levothyroxine). Caution in concomitant w/ drugs w/ narrow therapeutic range that are substrates for P-gp (eg, colchicine, dabigatran etexilate, digoxin). May inhibit BCRP & MRP2, organic anion transporter 3 (OAT3) & organic cation transporter (OCT1).
ATC Classification
L02BB04 - enzalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Xtandi softgel cap 40 mg
112's (P224,000/box)
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