Xtandi Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Enzalutamide

Indications/Uses

Adult men w/ high-risk non-metastatic castration-resistant prostate cancer (CRPC). Adult men w/ metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated & whose disease has progressed on or after docetaxel therapy.

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Dosage/Direction for Use

160 mg as single daily dose.

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Overdosage

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Administration

May be taken with or without food: Swallow whole w/ water, do not chew/dissolve/open cap.

Contraindications

Hypersensitivity. Pregnancy.

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Special Precautions

Discontinue use if posterior reversible encephalopathy syndrome develops. Hypersensitivity reactions. Risk of seizures; second primary malignancies; recent CV disease. Fructose intolerance. Avoid concomitant use w/ strong CYP2C8 inhibitors; warfarin, coumarin-like anticoagulants. Concomitant use w/ cytotoxic chemotherapy. May affect ability to drive & use machines. ESRD; severe renal & hepatic impairment. Not to be used in women of childbearing potential. Not to be used during pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hot flush, HTN; fractures; asthenia, fatigue; fall. Anxiety; headache, memory impairment, amnesia, attention disturbance, dysgeusia, restless legs syndrome; ischaemic heart disease; dry skin, pruritus; gynaecomastia.

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Drug Interactions

Increased AUC & decreased C_max w/ strong CYP2C8 inhibitors eg, gemfibrozil. Decreased AUC of midazolam, S-warfarin, omeprazole. 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), CYP3A4-metabolized statins (eg, atorvastatin, simvastatin), thyroid agents (eg, levothyroxine); P-gp substrates eg, colchicine, dabigatran etexilate, digoxin.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BB04 - enzalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Xtandi softcap 40 mg

Packing/Price

112's

Xtandi

enzalutamide

Manufacturer:

Astellas Pharma

Distributor:

DKSH