Erleada 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

Apalutamide

Indications/Uses

Non-metastatic castration-resistant prostate cancer in adult men who are at high risk of developing metastatic disease. Metastatic hormone-sensitive prostate cancer in adult men in combination w/ androgen deprivation therapy.

Click to view Erleada detailed prescribing information

Dosage/Direction for Use

240 mg daily as single dose.

Click to view Erleada detailed prescribing information

Overdosage

View Erleada overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Hypersensitivity. Women of childbearing potential. Pregnancy.

Click to view Erleada detailed prescribing information

Special Precautions

Not recommended in patients w/ history of seizures or other predisposing factors eg, underlying brain injury, recent stroke (w/in 1 yr), primary brain tumours or brain metastases. Clinically significant CV disease w/in past 6 mth eg, severe/unstable angina, MI, symptomatic CHF, arterial or venous thromboembolic events or ventricular arrhythmias. History of or risk factors for QT prolongation. Evaluate & monitor for fractures or fall risk prior to & during therapy. Avoid concomitant use w/ warfarin & coumarin-like anticoagulants. Concomitant use w/ QT interval-prolonging drugs. May affect ability to drive & use machines. Severe renal impairment. Not recommended in severe hepatic impairment. Women & men of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation.

Click to view Erleada detailed prescribing information

Use In Pregnancy & Lactation

Click to view Erleada detailed prescribing information

Adverse Reactions

Skin rash; fracture; arthralgia; fatigue; decreased wt; fall. Hypothyroidism; hypercholesterolaemia; hypertriglyceridaemia; pruritus, alopecia.

Click to view Erleada detailed prescribing information

Drug Interactions

Decreased C_max & increased AUC w/ strong CYP2C8 inhibitors. Decreased C_max w/ strong CYP3A4 inhibitors. Monitor for AR w/ CYP2B6 substrates. Decreased AUC of midazolam, omeprazole, warfarin, fexofenadine, rosuvastatin. Lowered exposure to darunavir, felodipine, simvastatin, diazepam, phenytoin, l-thyroxine, valproic acid. Lowered exposure of colchicine, dabigatran etexilate, digoxin, lapatinib, MTX, repaglinide. QT interval-prolonging drugs or Torsade de pointes-inducing drugs eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics eg, haloperidol.

Click to view Erleada detailed prescribing information

Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Erleada detailed prescribing information

Storage

View Erleada storage conditions for details to ensure optimal shelf-life.

Description

View Erleada description for details of the chemical structure and excipients (inactive components).

Action

View Erleada mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class

Cancer Hormone Therapy

ATC Classification

L02BB05 - apalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.

Regulatory Classification

Presentation/Packing

Form

Erleada FC tab 60 mg

Packing/Price

120's

Erleada

apalutamide

Manufacturer:

Janssen

Distributor:

Zuellig Pharma