Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Astellas Pharma (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS ENZALUTAMIDE 40,0 mg
Registered
2018-06-09
Xtandi 40 mg Soft gelatine capsule 1.3.2 Final PIL November 2023 Astellas Page 1 of 10 SCHEDULING STATUS: S4 XTANDI 40 MG (ENZALUTAMIDE) soft gelatine capsules contains Sugar: Each capsule contains 57,8 mg Sorbitol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING XTANDI • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • XTANDI has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What XTANDI is and what it is used for 2. What you need to know before you take XTANDI 3. How to take XTANDI 4. Possible side effects 5. How to store XTANDI 6. Contents of the pack and other information 1. WHAT XTANDI IS AND WHAT IT IS USED FOR The active substance in Xtandi is enzalutamide. XTANDI is used to treat adult men with prostate cancer that: - No longer responds to hormone therapy or surgical treatment to lower testosterone Or Xtandi 40 mg Soft gelatine capsule 1.3.2 Final PIL November 2023 Astellas Page 2 of 10 - Has spread to other parts of the body and responds to hormone therapy or surgical treatment to lower testosterone. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XTANDI DO NOT TAKE XTANDI: • if you are hypersensitive (allergic) to the active ingredient, enzalutamide or to any of the other ingredients. • if you have poorly controlled seizures. • XTANDI is not for use by women._ _ WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or other healthcare professional before taking XTANDI: • If you are taking any medicines to prevent blood clots (e.g. warfarin) • If you use chemotherapy like docetaxel. • If you have problems with your liver. • If you have problems with your kidneys. • If you had or are at risk of having a seizure (fit). _Seizures _ XTANDI has been shown to cause seizures. Some situations in which you may have a higher risk of seizures include: - If you had earlier epi Đọc toàn bộ tài liệu
Xtandi 40 mg Soft gelatine capsule 1.3.1.1 Final PI November 2023 Astellas Page 1 of 19 SCHEDULING STATUS S4 1 NAME OF THE MEDICINE XTANDI 40 mg soft gelatine capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each soft capsule contains 40 mg of enzalutamide. Contains sugar: Each capsule contains 57,8 mg sorbitol. For the full list of excipients, (see section 6.1). 3 PHARMACEUTICAL FORM Soft capsule. Opaque white to off-white oblong soft gel capsule, printed with “ENZ” in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xtandi is indicated for - the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT). - the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC). - the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. - the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. Xtandi 40 mg Soft gelatine capsule 1.3.1.1 Final PI November 2023 Astellas Page 2 of 19 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The recommended dose of Xtandi is 160 mg (four 40 mg capsules) as a single oral daily dose. Medical castration with a luteinising hormone-releasing hormone (LHRH) analogue should be continued during treatment of patients not surgically castrated. If a patient misses taking Xtandi at the usual time, the prescribed dose should be taken as close as possible to the usual time. If a patient misses a dose for a whole day, treatment should be resumed the following day with the usual daily dose. If a patient experiences a ≥ Grade 3 toxicity or an intolerable adverse reaction, dosing should be withheld for one week or until symptoms improve to ≤ Grade 2, then resumed at a reduced dose (120 mg or 80 mg) if warranted._ _The patient then requires frequent monitoring for the return of that Đọc toàn bộ tài liệu