Abiraterone acetate

Indications & Dose:

Metastatic castration-resistant prostate cancer in patients whose disease has progressed during or after treatment with a docetaxel-containing chemotherapy regimen (in combination with prednisone or prednisolone) | Metastatic castration-resistant prostate cancer in patients who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (in combination with prednisone or prednisolone).

BY MOUTH

Adult: 1 g once daily for dose of concurrent prednisone or prednisolone-consult product literature

Contraindications:

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Side Effects:

Common or very common Angina . arrhythmia . atrial fibrillation . diarrhoea . dyspepsia . fractures . haematuria . heart failure . hepatotoxicity . hypertension . hypertriglyceridaemia . hypokalaemia . peripheral oedema .rash . sepsis .tachycardia . urinary tract infection

Uncommon Adrenal insufficiency . myopathy . rhabdomyolysis Rare Allergic alveolitis

CONCEPTION AND CONTRACEPTION Men should use condoms if their partner is pregnant and use condoms in combination with another effective contraceptive method if their partner is of child-bearing potential.

HEPATIC IMPAIRMENT Use with caution in moderate impairment and only if benefit clearly outweighs risk. Avoid in severe impairment.

RENAL IMPAIRMENT Use with caution in severe impairment .

MONITORING REQUIREMENTS

Monitor blood pressure, serum potassium concentration and fluid balance before treatment and at least monthly during treatment-consult product literature for management of hypertension, hypokalaemia and oedema. Monitor liver function before treatment then every 2 weeks for the first 3 months of treatment then monthly thereafter-interrupt treatment if serum alanine aminotransferase or aspartate aminotransferase greater than 5 times the upper limit (consult product literature for details of restarting treatment at a lower dose) and discontinue permanently if 20 times the upper limit. 842 Hormone responsive malignancy. Immune system and malignant disease.

Cautions:

Diabetes (increased risk of hyperglycaemia-monitor blood sugar frequently). history of cardiovascular disease

Cardiovascular disease Correct hypertension and hypokalaemia before treatment (if significant risk of congestive heart failure such as history of cardiac failure, uncontrolled hypertension or cardiac events, consult product literature for management and increased monitoring).

Precautions:

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Interaction:

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Warnings:

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Adverse Effects:

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Lactations:

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Special Precautions:

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Counselling:

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Side Effects Or Adverse Reactions:

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Patient And Carer Advice:

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