Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
enzalutamide
Astellas Pharma Europe B.V.
L02BB04
enzalutamide
Endocrine therapy
Prostatic Neoplasms
Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).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 (see section 5.1).the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Revision: 21
Authorised
2013-06-21
71 B. PACKAGE LEAFLET 72 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XTANDI 40 MG SOFT CAPSULES enzalutamide 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. 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 Xtandi contains the active substance enzalutamide. Xtandi is used to treat adult men with prostate cancer that: - No longer responds to a hormone therapy or surgical treatment to lower testosterone Or - Has spread to other parts of the body and responds to a hormone therapy or surgical treatment to lower testosterone. HOW XTANDI WORKS Xtandi is a medicine that works by blocking the activity of hormones called androgens (such as testosterone). By blocking androgens, enzalutamide stops prostate cancer cells from growing and dividing. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XTANDI DO NOT TAKE XTANDI - If you are allergic to enzalutamide or any of the other ingredients of this medicine (listed in section 6) - If you are pregnant or may become pregnant (see ‘Pregnancy, breast-feeding and fertility’) WARNINGS AND PRECAUTIONS Seizures Seizures were reported in 5 in every 1,000 people taking Xtandi, and fewer than 3 in every 1,000 people taking placebo (see ‘Other medicines and Xtandi’ below and section 4 ‘Possible side effects’). If you are taking a medicine that can cause seizures or that can increase the susceptibility for h Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Xtandi - 40 mg soft capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xtandi - 40 mg soft capsules Each soft capsule contains 40 mg of enzalutamide. Excipient(s) with known effect Each soft capsule contains 57.8 mg of sorbitol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Soft capsule. White to off-white oblong soft capsules (approximately 20 mm x 9 mm) imprinted with “ENZ” in black ink on one side. 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 (see section 5.1). • the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). • 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 (see section 5.1). • the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with enzalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology The recommended dose is 160 mg enzalutamide (four 40 mg soft 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 Aqra d-dokument sħiħ