Abirone

Abirone

abiraterone

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Abiraterone acetate
Indications/Uses
In combination w/ prednisone or prednisolone for metastatic castration resistant prostate cancer (mCRPC) in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy; have received prior chemotherapy containing taxane. In combination w/ androgen deprivation therapy (ADT) & prednisone/prednisolone in adult men w/ newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC).
Dosage/Direction for Use
mCRPC 1,000 mg as single daily dose w/ prednisone or prednisolone 10 mg daily. mHSPC 1,000 mg as single daily dose w/ prednisone or prednisolone 5 mg daily.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Severe hepatic impairment. Women of childbearing potential.
Special Precautions
Discontinue use if severe hepatotoxicity develops. HTN, hypokalaemia, fluid retention; heart failure, recent MI or ventricular arrhythmia; history of CV disease. Measure serum transaminases prior to, every 2 wk for 1st 3 mth & mthly thereafter. Monitor BP, serum K & fluid retention at least mthly; adrenocortical insufficiency. Measure blood sugar in diabetic patients frequently. Concomitant use w/ cytotoxic chemotherapy. Not recommended in combination w/ radium 223 dichloride. Closely monitor liver function if ALT or AST rises >5x ULN or bilirubin rises >3x ULN. Moderate hepatic impairment. Not to be used in severe hepatic impairment. Patient should use effective contraceptive method. Not to be used in women of childbearing potential. Pregnancy & lactation.
Adverse Reactions
UTI; hypokalemia; HTN; diarrhea; peripheral oedema. Sepsis; hypertriglyceridemia; cardiac failure including CHF, left ventricular dysfunction & decreased ejection fraction, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; increased ALT &/or AST, abnormal hepatic function; rash; haematuria; fractures including all fractures w/ exception of pathological fracture.
Drug Interactions
Increased absorption w/ food. Avoid use w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb. CYP2D6 & CYP2C8 inhibitors. CYP2D6-metabolized drugs particularly drugs w/ narrow therapeutic index. Increased hyperglycaemia w/ glucocorticoids. Lowered response rate in patients previously treated w/ ketoconazole.
MIMS Class
Cancer Hormone Therapy
ATC Classification
L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.
Presentation/Packing
Form
Abirone tab 250 mg
Packing/Price
120's
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