Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
apalutamide
Janssen-Cilag International NV
L02BB05
apalutamide
Endocrine therapy
Prostatic Neoplasms
Erleada is indicated:in adult men for the treatment of non metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).
Revision: 11
Authorised
2019-01-14
81 B. PACKAGE LEAFLET 82 PACKAGE LEAFLET: INFORMATION FOR THE USER ERLEADA 60 MG FILM-COATED TABLETS apalutamide 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 Erleada is and what it is used for 2. What you need to know before you take Erleada 3. How to take Erleada 4. Possible side effects 5. How to store Erleada 6. Contents of the pack and other information 1. WHAT ERLEADA IS AND WHAT IT IS USED FOR WHAT ERLEADA IS Erleada is a cancer medicine that contains the active substance ‘apalutamide’. WHAT ERLEADA IS USED FOR It is used to treat adult men with prostate cancer that: has metastasised to other parts of the body and still responds to medical or surgical treatments that lower testosterone (also called hormone-sensitive prostate cancer). has not metastasised to other parts of the body and no longer responds to medical or surgical treatment that lowers testosterone (also called castration-resistant prostate cancer). HOW ERLEADA WORKS Erleada works by blocking the activity of hormones called androgens (such as testosterone). Androgens can cause the cancer to grow. By blocking the effect of androgens, apalutamide stops prostate cancer cells from growing and dividing. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ERLEADA DO NOT TAKE ERLEADA if you are allergic to apalutamide or any of the other ingredients of this medicine (listed in section 6). if you are a woman who is pregnant or may become pregnant (see the Pregnancy and contraception section below for more informatio Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Erleada 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 60 mg of apalutamide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Slightly yellowish to greyish green, oblong-shaped, film-coated tablets (17 mm long x 9 mm wide), debossed with “AR 60” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Erleada is indicated: in adult men for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT) (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with apalutamide should be initiated and supervised by specialist physicians experienced in the medical treatment of prostate cancer. Posology The recommended dose is 240 mg (four 60 mg tablets) as an oral single daily dose. Medical castration with gonadotropin releasing hormone analogue (GnRHa) should be continued during treatment in patients not surgically castrated. If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Extra tablets should not be taken to make up the missed dose. If a ≥ Grade 3 toxicity or an intolerable adverse reaction is experienced by the patient, dosing should be held rather than permanently discontinuing treatment until symptoms improve to ≤ Grade 1 or original grade, then should be resumed at the same dose or a reduced dose (180 mg or 120 mg), if warranted. For the most common adverse reactions, (see section 4.8). _Special populations_ _Elderly_ No dose adjustment is necessary for elderly patients (see sections 5.1 and 5.2). 3 _Renal impairment_ No dose adjustment is necessary for patients with mild to modera Aqra d-dokument sħiħ