Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Ponatinib
Incyte Biosciences Distribution B.V.
L01EA05
ponatinib
Antineoplastic agents, Protein kinase inhibitors
Leukemia, Myeloid; Leukemia, Lymphoid
Iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutationPhiladelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.
Revision: 25
Authorised
2013-07-01
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ICLUSIG 15 MG FILM-COATED TABLETS ICLUSIG 30 MG FILM-COATED TABLETS ICLUSIG 45 MG FILM-COATED TABLETS ponatinib 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 Iclusig is and what it is used for 2. What you need to know before you take Iclusig 3. How to take Iclusig 4. Possible side effects 5. How to store Iclusig 6. Contents of the pack and other information 1. WHAT ICLUSIG IS AND WHAT IT IS USED FOR Iclusig is USED TO TREAT adults with the following LEUKAEMIA types who are no longer benefiting from treatment with other medicines, or have a certain genetic difference known as a T315I mutation: • chronic myeloid leukaemia (CML): a blood cancer involving too many abnormal white blood cells in the blood and the bone marrow (where blood cells are formed). • Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): a type of leukaemia involving too many immature white blood cells in the blood and blood forming bone marrow. In this kind of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, the Philadelphia chromosome. Iclusig belongs to a group of medicines called tyrosine kinase inhibitors. In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells. Iclusig blocks this signal, thereby stopping the production of these cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ICLUSIG DO NOT TAKE ICL Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg film-coated tablets Iclusig 30 mg film-coated tablets Iclusig 45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Iclusig 15 mg film-coated tablets Each film-coated tablet contains 15 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 40 mg of lactose monohydrate. Iclusig 30 mg film-coated tablets Each film-coated tablet contains 30 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 80 mg of lactose monohydrate. Iclusig 45 mg film-coated tablets Each film-coated tablet contains 45 mg of ponatinib (as hydrochloride). _Excipients with known effect _ Each film-coated tablet contains 120 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Iclusig 15 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side. Iclusig 30 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 8 mm in diameter, with "C7" debossed on one side. Iclusig 45 mg film-coated tablets White, biconvex, round film-coated tablet that is approximately 9 mm in diameter, with “AP4” debossed on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iclusig is indicated in adult patients with • chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation 3 • Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation. See sections 4.2 for the assessm Aqra d-dokument sħiħ