País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
gilteritinib fumarate
Astellas Pharma Europe B.V.
L01EX13
gilteritinib
Antineoplastic agents
Leukemia, Myeloid, Acute
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.,
Revision: 5
Authorised
2019-10-24
24 B. PACKAGE LEAFLET 25 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT XOSPATA 40 MG FILM - COATED TABLETS gilteritinib 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, pharmacist or nurse. - 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 Xospata is and what it is used for 2. What you need to know before you take Xospata 3. How to take Xospata 4. Possible side effects 5. How to store Xospata 6. Contents of the pack and other information 1. WHAT XOSPATA IS AND WHAT IT IS USED FOR WHAT XOSPATA IS Xospata belongs to a class of cancer medicines called protein kinase inihibitors. It contains the active substance gilteritinib. WHAT XOSPATA IS USED FOR Xospata is used to treat adults with acute myeloid leukaemia (AML), a cancer of certain white blood cells. Xospata is used if AML is linked to an alteration of a gene called FLT3, and is given to patients whose disease has come back or has not improved after previous treatment. HOW XOSPATA WORKS In AML, patients develop large numbers of abnormal white blood cells. Gilteritinib blocks the action of certain enzymes (kinases) needed for the abnormal cells to multiply and grow, thus preventing the growth of the cancer. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE XOSPATA DO NOT TAKE XOSPATA - if you are allergic to gilteritinib or any of the other ingredients of this medicine (listed in section Leer el documento completo
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 Xospata 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 40 mg gilteritinib (as fumarate) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Round, light yellow film-coated tablet, debossed with the company logo and ‘235’ on the same side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Xospata should be initiated and supervised by a physician experienced in the use of anti-cancer therapies. Before taking gilteritinib, relapsed or refractory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. Xospata may be re-initiated in patients following haematopoietic stem cell transplantation (HSCT) (see Table 1). Posology The recommended starting dose is 120 mg gilteritinib (three 40 mg tablets) once daily. Blood chemistries, including creatine phosphokinase, should be assessed prior to initiation of treatment, on day 15 and monthly for the duration of treatment. An electrocardiogram (ECG) should be performed before initiation of gilteritinib treatment, on day 8 and 15 of cycle 1 and prior to the start of the next three subsequent months of treatment (see sections 4.4 and 4.8). Treatment should continue until the patient is no longer clinically benefiting from Xospata or until unacceptable toxicity occurs. Response may be delaye Leer el documento completo