Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Ponatinib Free Base (added as ponatinib HCl)
SMART MEDICINE SDN. BHD.
Ponatinib Free Base (added as ponatinib HCl)
30 Tablets
PATHEON INC.
_Consumer Medication Information Leaflet (RiMUP) _ _ _ Page 1 ICLUSIG ® FILM-COATED TABLETS Ponatinib (15 mg and 45 mg) WHAT IS IN THIS LEAFLET 1. WHAT IS ICLUSIG USED FOR 2. HOW ICLUSIG WORKS 3. BEFORE YOU USE ICLUSIG 4. HOW TO USE ICLUSIG 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF ICLUSIG 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER Please refer to the Patient Medication Guide that comes with Iclusig before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. If you have any questions about Iclusig, ask your healthcare provider. WHAT ICLUSIG 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 - rearranged to form an abnormal chromosome, the Philadelphia chromosome. HOW ICLUSIG WORKS 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. BEFORE YOU USE ICLUSIG _WHEN YOU MUST NOT USE IT _ Do not take Iclusig if you are allergic to ponatinib or any of the other ingredients of this medicine. See the end of this leaflet for a list of ingredients in Iclusig. _BEFORE YOU START TO USE Soma hati kamili
1 ICLUSIG ® TABLETS PONATINIB 1. NAME OF THE MEDICINAL PRODUCT Iclusig 15 mg and 45 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 15 mg film-coated tablet contains 15 mg of ponatinib (as hydrochloride). Each 45 mg film-coated tablet contains 45 mg of ponatinib (as hydrochloride). Excipients with known effect Each 15 mg film-coated tablet contains 40 mg of lactose monohydrate. Each 45 mg 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). 15 mg: White, biconvex, round film-coated tablet that is approximately 6 mm in diameter, with "A5" debossed on one side. 45 mg: 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 suffering from: • Philadelphia-positive (Ph+) chronic myeloid leukaemia (chronic phase, accelerated phase or blast phase) or Ph+ acute lymphoblastic leukaemia for whom a treatment with other c-abl tyrosine kinase inhibitors is not appropriate, or • T315I-positive Ph+ chronic myeloid leukaemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ acute lymphoblastic leukaemia. See sections 4.2 for the assessment of cardiovascular status prior to start of therapy and 4.4 for situations where an alternative treatment may be considered. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the diagnosis and treatment of patients with leukaemia. Haematologic support such as platelet transfusion and haematopoietic growth factors can be used during treatment if clinically indicated. Before starting treatment with ponatinib, the cardiovascular status of the patient should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed. Cardiovascular status should continue to be monitored and medical and Soma hati kamili