Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
abiraterone acetate
Janssen-Cilag International N.V.
L02BX03
abiraterone
Endocrine therapy
Prostatic Neoplasms
Zytiga is indicated with prednisone or prednisolone for:the treatment of metastatic castration resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicatedthe treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.
Revision: 26
Authorised
2011-09-05
63 B. PACKAGE LEAFLET 64 PACKAGE LEAFLET: INFORMATION FOR THE USER ZYTIGA 250 MG TABLETS abiraterone acetate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What ZYTIGA is and what it is used for 2. What you need to know before you take ZYTIGA 3. How to take ZYTIGA 4. Possible side effects 5. How to store ZYTIGA 6. Contents of the pack and other information 1. WHAT ZYTIGA IS AND WHAT IT IS USED FOR ZYTIGA contains a medicine called abiraterone acetate. It is used to treat prostate cancer in adult men that has spread to other parts of the body. ZYTIGA stops your body from making testosterone; this can slow the growth of prostate cancer. When ZYTIGA 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 chemical known as potassium in your blood. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYTIGA DO NOT TAKE ZYTIGA - if you are allergic to abiraterone acetate or any of the other ingredients of this medicine (listed in section 6). - if you are a woman, especially if pregnant. ZYTIGA is for use in male patients only. - if you have severe liver damage. - in combination with Ra-223 (which is used to treat prostate cancer). Do not take Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ZYTIGA 250 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 250 mg of abiraterone acetate equivalent to 223 mg of abiraterone. Excipients with known effect Each tablet contains 198.65 mg of lactose monohydrate and 6.8 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to off-white oval tablets (15.9 mm long x 9.5 mm wide), debossed with AA250 on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZYTIGA is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1) 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product should be prescribed by an appropriate healthcare professional. Posology The recommended dose is 1 000 mg (four 250 mg tablets) as a single daily dose that must not be taken with food (see “Method of administration” below). Taking the tablets with food increases systemic exposure to abiraterone (see sections 4.5 and 5.2). _Dosage of prednisone or prednisolone_ For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily. For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily. Medical castration with luteinising hormone releasing hormone (LHRH) analogue should be continued during treatment in patients not surgically castrated. _Recommended monitoring_ Serum transaminases should be measured prior to starting treatment, every two weeks for the first three months of tre Прочетете целия документ