Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Axicabtagene ciloleucel
Kite Pharma EU B.V.
L01XX70
axicabtagene ciloleucel
Antineoplastic agents
Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
Yescarta is indicated for the treatment of adult patients with diffuse large B cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy.Yescarta is indicated for the treatment of adult patients with relapsed or refractory (r/r) DLBCL and primary mediastinal large B cell lymphoma (PMBCL), after two or more lines of systemic therapy.Yescarta is indicated for the treatment of adult patients with r/r follicular lymphoma (FL) after three or more lines of systemic therapy.
Revision: 12
Authorised
2018-08-23
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT YESCARTA 0.4 – 2 × 10 8 CELLS DISPERSION FOR INFUSION axicabtagene ciloleucel (CAR+ viable T cells) 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 ARE GIVEN 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. - Your doctor will give you a Patient Alert Card. Read it carefully and follow the instructions on it. - Always show the Patient Alert Card to the doctor or nurse when you see them or if you go to hospital. - 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 Yescarta is and what it is used for 2. What you need to know before you are given Yescarta 3. How Yescarta is given 4. Possible side effects 5. How to store Yescarta 6. Contents of the pack and other information 1. WHAT YESCARTA IS AND WHAT IT IS USED FOR Yescarta is a gene therapy medicine used for treating adults with aggressive diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma (FL) affecting your lymph tissue (part of the immune system) that affects a type of white blood cell called B lymphocytes and other organs in your body. Too many of these abnormal white blood cells accumulate in your tissue and this is the cause of the symptoms you may have. The medicine is made specially for you as a single administration of your own modified white blood cells. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YESCARTA YOU MUST NOT BE GIVEN YESCARTA: - if you are allergic to axicabtagene ciloleucel or any of the other ingredients of this medicine (listed in sect Aqra d-dokument sħiħ
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 Yescarta 0.4 – 2 × 10 8 cells dispersion for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Yescarta (axicabtagene ciloleucel) is a genetically modified autologous cell-based product containing T cells transduced _ex vivo_ using a retroviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (ScFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each patient-specific infusion bag of Yescarta contains axicabtagene ciloleucel at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells). The medicinal product is packaged in one infusion bag overall containing a cell dispersion for infusion of a target dose of 2 × 10 6 anti-CD19 CAR-positive viable T cells per kg of body weight (range: 1 × 10 6 – 2 × 10 6 cells/kg), with a maximum of 2 × 10 8 anti-CD19 CAR-positive viable T cells suspended in a cryopreservative solution. Each infusion bag contains approximately 68 mL of dispersion for infusion. Excipients with known effect Each bag of Yescarta contains 300 mg sodium and 3.4 mL of dimethyl sulfoxide (DMSO). Yescarta may contain residual amounts of gentamicin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Dispersion for infusion. A clear to opaque, white to red dispersion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Yescarta is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months fro Aqra d-dokument sħiħ