Abiraterone STELLA 250 mg

Rx

Indications

Treatment of hormone-sensitive metastatic prostate cancer (mHSPC) in adult men, in combination with androgen deprivation therapy (ADT) in the following cases:

• No symptoms or very mild symptoms after androgen deprivation therapy and prior clinical chemotherapy.
• During the disease’s progression or after a course of chemotherapy containing docetaxel.

Typically, abiraterone is used in combination with prednisone or prednisolone to enhance treatment efficacy.

Dosage

• Recommended dose: 4 tablets (1000 mg)/day, taken once daily.
• For hormone-sensitive metastatic prostate cancer (mHSPC): Use Abiraterone STELLA 250 mg in combination with 0.5 mg prednisone or prednisolone daily.
• For metastatic castration-resistant prostate cancer (mCRPC): Use Abiraterone STELLA 250 mg in combination with 0.10 mg prednisone or prednisolone daily.
• Oral function suppression therapy with LHRH agonists should be continued during treatment in patients who have not undergone orchiectomy.
• If a dose is missed, take it the next day at the usual daily dose.
• Do not use this medication in children.
• No dose adjustment is needed for patients with hepatic or renal impairment.

Administration

• Take Abiraterone STELLA 250 mg tablets whole with water, once daily on an empty stomach. Taking Abiraterone STELLA 250 mg with food increases the systemic effects of the drug.
• It is recommended to take Abiraterone STELLA 250 mg at least 2 hours after a meal. Do not eat for at least 1 hour after taking the medication.

• Individuals with a history of hypersensitivity to abiraterone  or to any ingredient of the drug.
• Abiraterone is strictly for men and can harm an unborn baby. Women who are pregnant or may become pregnant should not handle the tablets without protection (e.g., gloves).
• Patients with severe hepatic impairment.
• Abiraterone in combination with prednisone or prednisolone is contraindicated for use with radium Ra-223 due to an increased risk of fractures and mortality.

Possible adverse reactions:

Very common:

• Urinary tract infection,
• Hypokalaemia,
• Hypertension,diarrhea,
• Alanine aminotransferase increased and/or aspartate aminotransferase increased,
• Oedema peripheral.

Common:

• Sepsis,
• Hypertriglyceridaemia,
• Cardilac failure,
• Angina pectoris,
• Atrial fibrillation,
• Tachycardia,
• Dyspepsia,
• Rash,
• Haematuria,
• Fractures.

• Abiraterone acetate carries the risk of causing hypertension, hypokalemia, fluid retention, etc., so caution is needed when using it in patients with a history of cardiovascular disease, heart failure, severe kidney failure, angina pectoris, or myocardial infarction, and these indicators should be monitored throughout the duration of treatment.
• Before starting drug therapy, patients need to have their liver function and the degree of liver failure assessed. In cases of severe liver toxicity, the use of abiraterone acetate should be discontinued.
• Caution is advised and monitoring for adrenocortical insufficiency should occur if patients are withdrawn from prednisone or prednisolone. If abiraterone acetate is continued after corticosteroids are withdrawn, patients should be monitored for symptoms of mineralocorticoid excess.
• Decreased bone density may occur in men with metastatic advanced prostate cancer. The use of abiraterone acetate in combination with a glucocorticoid could increase this effect.
• Lower rates of response might be expected in patients previously treated with ketoconazole for prostate cancer.
• The use of glucocorticoids could increase hyperglycaemia, therefore blood sugar should be measured frequently in patients with diabetes.
• Cases of hypoglycaemia have been reported when abiraterone acetate plus prednisone/prednisolone was administered to patients with pre-existing diabetes receiving pioglitazone or repaglinide; therefore, blood sugar should be monitored in patients with diabetes.
• The safety and efficacy of concomitant use of abiraterone acetate with cytotoxic chemotherapy has not been established
• Anaemia and sexual dysfunction may occur in men with metastatic prostate cancer including those undergoing treatment with abiraterone acetate.
• Cases of myopathy and rhabdomyolysis have been reported in patients treated with abiraterone acetate. Most cases developed within the first 6 months of treatment and recovered after abiraterone acetate withdrawal. Caution is recommended in patients concomitantly treated with medicinal products known to be associated with myopathy/rhabdomyolysis.
• Strong inducers of CYP3A4 during treatment are to be avoided unless there is no therapeutic alternative, due to risk of decreased exposure to abiraterone.
• Abiraterone acetate should not be used by pregnant women, women who may become pregnant, or women who are breastfeeding.
• Abiraterone acetate has no or negligible influence on the ability to drive and use machines.