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Admatrone 250 Tablets

Generic Name– Abiraterone acetate
Drug Class– Antineoplastic agentAbiraterone acetate is a new cytochrome P450 (CYP) 17 inhibitor approved by the FDA for use in combination with prednisone for castration resistant prostate cancer. It selectively inhibits androgen biosynthesis by blocking cytochrome P450 c17 (CYP17), a critical enzyme in testosterone synthesis and highly expressed in adrenal glands, testes and within the prostate tumor.

Category

Product Description

Admatrone (Abiraterone acetate) is an anticancer drug, available in tablet form for oral administration.

Indications and Usage

• Abiraterone is indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel

Dosage and Administration

• Dosage Regimen for Prostate Cancer
Abiraterone acetate plus prednisone (AAP) Regimen
Abiraterone acetate- 1,000 mg orally once daily
Prednisone- 5 mg orally twice daily
• It should be taken on an empty stomach and no food should be consumed for at least two hours before the dose is taken and for at least one hour after the dose is taken

Dosage Forms and Strength
• Supplied as tablets for oral use
• Available in 250mg strength

Clinical Efficacy

• Prolongs overall survival among patients with metastatic castration-resistant prostate cancer who previously received chemotherapy with a low frequency of additional treatment-related toxic effects.
• Shows significant antitumor activity among both patients with progressing castration-resistant prostate cancer who had not received chemotherapy and those who had received chemotherapy.
• Improves median radiographic progression-free survival (rPFS) from 8 to 16 months and median overall survival (OS) from 30.3 to 34.7 months

Adverse Reactions
• The most common adverse reactions which occurs with administration of abiraterone are cough, diarrhea, hot flush, dyspepsia, urinary tract infections, joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, and upper respiratory tract infection

Contraindications
• It is contraindicated in women who are or may become pregnant

Special Precautions

• Consider starting dose of 250mg and further dose reduction in patients with baseline moderate hepatic impairment
• Hold abiraterone treatment in patients who develop hepatotoxicity during treatment and initiate retreatment at a reduced dose
• Discontinue use of abiraterone in patients with severe renal and hepatic impairment
• Use abiraterone with caution in patients with a history of cardiovascular disease as the safety of abiraterone is not established in patients with heart failure
• Control hypertension and correct hypokalemia before treatment and monitor blood pressure, serum potassium and symptoms of fluid retention at least once in a month
• Monitor for symptoms and signs of adrenocortical insufficiency and indicate increased dose of corticosteroids before, during and after stressful situations
• Avoid co-administration of abiraterone with CYP2D6 substrates that have a narrow therapeutic index and consider a dose reduction of the concomitant CYP2D6 substrate, if an alternative treatment cannot be used

Admatrone 250 Tablets - ADMAC Life Science