Nazione: Unione Europea
Lingua: inglese
Fonte: EMA (European Medicines Agency)
daunorubicin hydrochloride, cytarabine
Jazz Pharmaceuticals Ireland Limited
L01XY01
daunorubicin, cytarabine
Antineoplastic agents
Leukemia, Myeloid, Acute
Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Revision: 9
Authorised
2018-08-23
28 B. PACKAGE LEAFLET 29 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VYXEOS LIPOSOMAL 44 MG/100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION daunorubicin and cytarabine 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 nurse. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Vyxeos liposomal is and what it is used for 2. What you need to know before you are given Vyxeos liposomal 3. How you are given Vyxeos liposomal 4. Possible side effects 5. How to store Vyxeos liposomal 6. Contents of the pack and other information 1. WHAT VYXEOS LIPOSOMAL IS AND WHAT IT IS USED FOR WHAT VYXEOS LIPOSOMAL IS Vyxeos liposomal belongs to a group of medicines called ‘antineoplastics’ used in cancer. It contains two active substances, called ‘daunorubicin’ and ‘cytarabine’, in the form of tiny particles known as ‘liposomes’. These active substances act in different ways to kill cancer cells by stopping them from growing and dividing. Packaging them in liposomes prolongs their action in the body and helps them to enter and kill the cancer cells. WHAT VYXEOS LIPOSOMAL IS USED FOR Vyxeos liposomal is used to treat patients with newly diagnosed acute myeloid leukaemia (a cancer of the white blood cells). It is given when the leukaemia was caused by previous treatments (known as therapy related acute myeloid leukaemia) or when there are certain changes in the bone marrow (known as acute myeloid leukaemia with “myelodysplasia-related changes”). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VYXEOS LIPOSOMAL _ _ YOU MUST NOT BE GIVEN VYXEOS LIPOSOMAL • if you are allergic to the active substances (daunorubicin or cytarabine) or any of the other ingredients of this medicine (listed in section 6). WARNINGS AN Leggi il documento completo
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for concentrate for solution for infusion contains 44 mg of daunorubicin and 100 mg of cytarabine. After reconstitution, the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes in a fixed combination in a 1:5 molar ratio. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Purple, lyophilised cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vyxeos liposomal is indicated for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vyxeos liposomal treatment should be initiated and monitored under the supervision of a physician experienced in the use of chemotherapeutic medicinal products. Vyxeos liposomal has a different posology than daunorubicin injection and cytarabine injection and it must not be interchanged with other daunorubicin and/or cytarabine containing products (see section 4.4). Posology Vyxeos liposomal dosing is based on the patient’s body surface area (BSA) according to the following schedule: TABLE 1: DOSE AND SCHEDULE FOR VYXEOS LIPOSOMAL THERAPY DOSING SCHEDULE FIRST INDUCTION daunorubicin 44 mg/m 2 and cytarabine 100 mg/m 2 on days 1, 3, and 5 SECOND INDUCTION daunorubicin 44 mg/m 2 and cytarabine 100 mg/m 2 on days 1 and 3 CONSOLIDATION daunorubicin 29 mg/m 2 and cytarabine 65 mg/m 2 on days 1 and 3 3 _Recommended dosing schedule for induction of remission _ The recommended dosing schedule of Vyxeos liposomal 44 mg/100 mg/m 2 , administered intravenously over 90 minutes: • on days 1, 3, and 5 as the first course of induction therapy. • on days 1 and 3 as subsequent course of induction therapy, if needed. A subsequent cou Leggi il documento completo