البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Abiraterone Acetate
JOHNSON & JOHNSON SDN BHD
Abiraterone Acetate
120tablet Tablets
PATHEON INC
ZYTIGA ® Abiraterone Acetate (250 mg; 500 mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What ZYTIGA ® is used for 2. How ZYTIGA ® works 3. Before you use ZYTIGA ® 4. How to use ZYTIGA ® 5. While you are using ZYTIGA ® 6. Side effects 7. Storage and disposal of ZYTIGA ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT ZYTIGA ® IS USED FOR ZYTIGA ® is indicated with prednisone or prednisolone for the treatment of prostate cancer that has spread to other parts of the body. HOW ZYTIGA ® WORKS ZYTIGA ® stops your body from making testosterone. Research has shown that testosterone helps to fuel the tumor. Reducing the production of testosterone is important to manage your illness. BEFORE YOU USE ZYTIGA ® - _When you must not use it _ _Pregnancy and lactation _ ZYTIGA ® must not be taken by women who are pregnant or breast- feeding or might be pregnant since ZYTIGA ® may affect the baby. If you are pregnant or might be pregnant, wear gloves if you need to touch or handle ZYTIGA ® 250 mg uncoated tablets. _Women, infants and children _ ZYTIGA ® is not for use in women and children. _ _ _ _ _Kidney disease _ ZYTIGA ® may be used in patients with kidney disease. _Liver disease _ You should not take ZYTIGA ® if you have severe liver disease. Your doctor will decide whether ZYTIGA ® can be used if you have mild or moderate liver problems. _ _ - _Before you start to use it _ ZYTIGA ® can make high blood pressure or heart failure or low blood potassium worse. Taking prednisone or prednisolone with ZYTIGA ® helps to avoid worsening of these conditions. If you have these conditions, or other heart or blood vessel problems, discuss them with your doctor. QT prolongation and Torsades de Pointes have been observed in patients who develop hypokalemia while taking ZYTIGA. Your blood pressure, serum potassium and signs and symptoms of fluid retention will be monitored clinically at least monthly. If you are having sex with a pregn اقرأ الوثيقة كاملة
1 1. PRODUCT NAME ZYTIGA ® (abiraterone acetate) 250 mg tablets ZYTIGA ® (abiraterone acetate) 500 mg film-coated tablets 2. DOSAGE FORMS AND STRENGTHS ZYTIGA tablet contains 250 mg of abiraterone acetate. ZYTIGA film coated tablets contain 500 mg of abiraterone acetate. 3. PHARMACEUTICAL FORM 250 MG UNCOATED TABLETS White to off-white oval tablets, debossed with “AA250” on one side. 500 MG FILM-COATED TABLETS Purple, oval shaped, film coated tablets, debossed with “AA” on one side and “500” on the other. For excipients, see PHARMACEUTICAL INFORMATION – List of Excipients. 4. CLINICAL INFORMATION 4.1 INDICATIONS ZYTIGA is indicated with prednisone or prednisolone for • the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). • the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. ZYTIGA is also indicated in combination with prednisone or prednisolone and androgen deprivation therapy (ADT) for the treatment of patients with newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) who may have received up to 3 months of prior ADT. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 1000 mg (two 500 mg tablets or four 250 mg tablets) as a single daily dose that must not be taken with food (see information on the method of administration). Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2). _Dosage of prednisone or prednisolone _ For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily. For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily. Medical castration with LHRH analogue should be continued during treatment in patients not surgically castrated. _Recommended monitoring _ Serum transaminases should be measured prior to starti اقرأ الوثيقة كاملة