Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abiraterone Acetate
DUOPHARMA HAPI SDN. BHD.
Abiraterone Acetate
120 Tablets
Natco Pharma Limited
_ _ _ _ _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_) 1 ARTESTO (ABIRATERONE ACETATE TABLETS USP 250MG) Abiraterone Acetate Tablet (250 mg) WHAT IS IN THE LEAFLET 1. What ARTESTO is used for 2. How ARTESTO works 3. Before you use ARTESTO 4. How to use ARTESTO 5. While you are using it 6. Side effects 7. Storage and Disposal of ARTESTO 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ARTESTO IS USED FOR This medicine is used with prednisone or prednisolone for the treatment of prostate cancer that has spread to other parts of the body. HOW ARTESTO WORKS ARTESTO contains the active ingredient called abiraterone acetate. ARTESTO works by stopping the body from making testosterone; this can slow the growth of prostate cancer. When ARTESTO is prescribed for the early stage of disease where it is still responding to hormone therapy, it is used with a treatment that lowers testosterone (androgen deprivation therapy). When you take this medicine your doctor will also prescribe another medicine called prednisone or prednisolone. This is to lower your chances of getting high blood pressure, having too much water in your body (fluid retention), or having reduced levels of a mineral known as potassium in your blood. BEFORE YOU USE ARTESTO - _When you must not take it_ _ _ _ _ Do not take this medicine if you have an allergy to: • abiraterone acetate • any of the other ingredients listed at the end of this leaflet Do not take this medicine if you are a woman, especially if pregnant. ARTESTO is for use in male patients only. Do not take this medicine if you have severe liver damage Do not take this medicine in combination with Ra-223 (which is used to treat prostate cancer). - _Before you start to use it _ Talk to your doctor before taking ARTESTO if you have: • Liver problems • High blood pressure or heart failure or low potassium (low blood potassium may increase risk of heart rhythm problems) • Experienced heart or blood vessel problems. • An Baca dokumen lengkap
Page 1 of 13 [REVISION DATE: 1059.092.2021] [DUOPHARMA HAPI SDN BHD] ARTESTO (ABIRATERONE ACETATE TABLETS USP 250MG)TABLET 250MG DESCRIPTION: White to off-white, oval shaped tablets debossed with “NA250” on one side and plain on other side. COMPOSITION: Each tablet contains 250 mg of abiraterone acetate. Excipients with known effect: Each tablet contains 198.65 mg of lactose and sodium. PHARMACODYNAMICS: Pharmacotherapeutic group: endocrine therapy, other hormone antagonists and related agents, ATC code: L02BX03 Mechanism of action Abiraterone acetate converted in vivo to abiraterone, an androgen biosynthesis inhibitor. Specifically, abiraterone selectively inhibits the enzyme 17α- hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is required for androgen biosynthesis in testicular, adrenal and prostatic tumour tissues. CYP17 catalyses the conversion of pregnenolone and progesterone into testosterone precursors, DHEA and androstenedione, respectively, by 17α- hydroxylation and cleavage of the C17,20 bond. CYP17 inhibition also results in increased mineralocorticoid production by the adrenals (see Warnings & Precautions). Androgen-sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with LHRH analogues or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumour. Treatment with abiraterone acetate tablets decreases serum testosterone to undetectable levels (using commercial assays) when given with LHRH analogues (or orchiectomy). Pharmacodynamic effects Abiraterone acetate tablets decrease serum testosterone and other androgens to levels lower than those achieved by the use of LHRH analogues alone or by orchiectomy. This results from the selective inhibition of the CYP17 enzyme required for androgen biosynthesis. PSA serves as a biomarker in patients with prostate cancer. In a Phase 3 clinical study of patients who failed prior chemotherapy with Baca dokumen lengkap