Abiraterone

Should be taken on an empty stomach. Take on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.

Severe hepatic impairment. Pregnancy and lactation. Women who may become pregnant. Concomitant use with radium Ra-223.

Patient with CV disease (e.g. heart failure, severe or unstable angina pectoris, recent MI, ventricular arrhythmia), diabetes. Patient subjected to unusual stress. Abiraterone formulations are not interchangeable, do not switch between products or formulations. Renal and moderate hepatic impairment. Patient Counselling Patients with female partners of childbearing potential must use effective birth control methods during therapy and for 3 weeks after stopping the treatment. Monitoring Parameters Monitor ALT, AST, and bilirubin before treatment, every 2 weeks for 3 months, and monthly thereafter. Monitor LFTs (for patient with moderate hepatic impairment) weekly for the 1st month, every 2 weeks for 2 months, and monthly thereafter. Monitor blood glucose (in patients with diabetes) during and after treatment discontinuation; serum K, blood pressure, fluid retention before treatment and monthly as necessary. Assess for signs and symptoms of adrenocorticoid insufficiency, hepatotoxicity.

Significant: Increased liver enzymes (including grade 3 and 4 events); mineralocorticoid excess, hypertension, hypokalaemia, fluid retention, hypo-hyper-glycaemia, decreased bone density, myopathy, rhabdomyolysis, anaemia, sexual dysfunction. Rarely, adrenocortical insufficiency (upon withdrawal from corticosteroid combination therapy); QT prolongation, torsades de pointes. Cardiac disorders: Tachycardia, atrial fibrillation, cardiac failure, angina pectoris. Gastrointestinal disorders: Diarrhoea, dyspepsia. General disorders and administration site conditions: Peripheral oedema. Infections and infestations: Sepsis. Injury, poisoning and procedural complications: Fractures. Metabolism and nutrition disorders: Hypertriglyceridaemia. Renal and urinary disorders: Haematuria, UTI. Skin and subcutaneous tissue disorders: Rash.
Potentially Fatal: Rarely, severe hepatotoxicity (e.g. fulminant hepatitis, acute liver failure).

Decreased serum concentration with potent CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, rifapentine, rifabutin, phenobarbital). May increase the serum concentration of drugs metabolised by CYP2D6 (e.g. dextromethorphan, thioridazine, codeine, oxycodone, tramadol, metoprolol, desipramine, venlafaxine, haloperidol, propafenone, risperidone, flecainide). Increased risk of QT prolongation with class IA antiarrhythmics (e.g. quinidine, disopyramide), class III antiarrhythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide), methadone, moxifloxacin, antipsychotics. Decreased therapeutic effect with spironolactone.

Hormonal Chemotherapy

L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.