Zuellig Pharma
Concise Prescribing Info
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.
Dosage/Direction for Use
May be taken with or without food: Swallow whole.
Hypersensitivity. Women of childbearing potential. Pregnancy.
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. Ischaemic heart disease & ischaemic cerebrovascular disorders. 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. Observe for signs & symptoms suggestive of SJS/TEN. 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. Not recommended in women of childbearing potential. Men w/ female partners of reproductive potential should use effective contraception. Not to be used during pregnancy & lactation.
Adverse Reactions
Decreased appetite; hot flush, HTN; diarrhoea; skin rash; fracture, arthralgia; fatigue; decreased wt; fall. Hypothyroidism; hypercholesterolaemia, hypertriglyceridaemia; dysgeusia, ichaemic cerebrovascular disorders; ischaemic heart disease; pruritus, alopecia; muscle spasm.
Drug Interactions
Decreased Cmax & increased AUC w/ strong CYP2C8 inhibitors. Decreased Cmax 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.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BB05 - apalutamide ; Belongs to the class of anti-androgens. Used in treatment of neoplastic diseases.
Erleada FC tab 60 mg
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