Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
venetoclax
AbbVie Ltd
L01XX52
venetoclax
Antineoplastic agents
Leukemia, Lymphocytic, Chronic, B-Cell
Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B cell receptor pathway inhibitor.
Authorised
2016-12-05
43 B. PACKAGE LEAFLET 44 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VENCLYXTO 10 MG FILM-COATED TABLETS VENCLYXTO 50 MG FILM-COATED TABLETS VENCLYXTO 100 MG FILM-COATED TABLETS venetoclax This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Venclyxto is and what it is used for 2. What you need to know before you take Venclyxto 3. How to take Venclyxto 4. Possible side effects 5. How to store Venclyxto 6. Contents of the pack and other information 1. WHAT VENCLYXTO IS AND WHAT IT IS USED FOR WHAT VENCLYXTO IS Venclyxto is a cancer medicine that contains the active substance venetoclax. It belongs to a group of medicines called “BCL-2 inhibitors”. WHAT VENCLYXTO IS USED FOR Venclyxto is used to treat patients with chronic lymphocytic leukaemia (CLL) with or without certain changes called “17p deletion” or “_TP53_ mutation” in their genes. For CLL with “17p deletion” or “_TP53_ mutation”, this medicine is used to treat patients who are unsuitable for or have been treated with one or more other types of medicines for their disease. For CLL without “17p deletion” or _“TP53_ mutation”, this medicine is used to treat patients who have been treated with two or more other types of medicines for their disease. CLL is a type of cancer affecting white blood Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Venclyxto 10 mg film-coated tablets Venclyxto 50 mg film-coated tablets Venclyxto 100 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Venclyxto 10 mg film-coated tablets Each film-coated tablet contains 10 mg of venetoclax. Venclyxto 50 mg film-coated tablets Each film-coated tablet contains 50 mg of venetoclax. Venclyxto 100 mg film-coated tablets Each film-coated tablet contains 100 mg of venetoclax. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Venclyxto 10 mg film-coated tablet Pale yellow, round biconvex shaped tablet 6 mm diameter debossed with V on one side and 10 on the other. Venclyxto 50 mg film-coated tablet Beige, oblong biconvex shaped tablet 14 mm long, 8 mm wide debossed with V on one side and 50 on the other. Venclyxto 100 mg film-coated tablet Pale yellow, oblong biconvex shaped tablet 17.2 mm long, 9.5 mm wide debossed with V on one side and 100 on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Venclyxto monotherapy is indicated for the treatment of chronic lymphocytic leukaemia (CLL) in the presence of 17p deletion or _TP53_ mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor. Venclyxto monotherapy is indicated for the treatment of CLL in the absence of 17p deletion or _TP53_ mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with venetoclax should be initiated and supervised by a physician experienced in the use of anticancer medicinal products. Posology The starting dose is 20 mg of venetoclax once daily for 7 days. T Прочитайте повний документ