Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
Brentuximab vedotin
Takeda Pharma A/S
L01XC12
brentuximab vedotin
Antineoplastic agents
Lymphoma, Non-Hodgkin; Hodgkin Disease
Hodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD).Adcetris is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT).Adcetris is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL):following ASCT, orfollowing at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option.Systemic anaplastic large cell lymphomaAdcetris in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL).Adcetris is indicated for the treatment of adult patients with relapsed or refractory sALCL.Cutaneous T cell lymphomaAdcetris is indicated for the treatment of adult patients with CD30+ cutaneous T cell lymphoma (CTCL) after at least 1 prior systemic therapy.
Revision: 35
Authorised
2012-10-25
55 B. PACKAGE LEAFLET 56 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ADCETRIS 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION BRENTUXIMAB VEDOTIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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. - If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Adcetris is and what it is used for 2. What you need to know before you are given Adcetris 3. How Adcetris will be given 4. Possible side effects 5. How to store Adcetris 6. Contents of the pack and other information 1. WHAT ADCETRIS IS AND WHAT IT IS USED FOR Adcetris contains the active substance BRENTUXIMAB VEDOTIN , an anti-cancer agent, which is made up of a monoclonal antibody linked to a substance intended to kill cancer cells. This substance is delivered to cancer cells by the monoclonal antibody. A monoclonal antibody is a protein which recognises certain cancer cells. Hodgkin lymphoma, systemic anaplastic large cell lymphoma and cutaneous T-cell lymphoma are types of cancer of the white blood cells. Classical Hodgkin lymphoma expresses specific proteins on the cell surface that are different from non-classical Hodgkin lymphoma. Adcetris is used to treat patients with advanced classical Hodgkin lymphoma who have not had treatment before. Adcetris will be given to you together with doxorubicin, vinblastine and dacarbazine which are other chemotherapy medicines used to treat Hodgkin lymphoma. Adcetris is used alone to lower the likelihood of classical Hodgkin lymphoma coming back after an autologous stem cell transplant in patients with certain risk factors. Adcetris is also used alone to treat classical Hodgkin lymphoma that has: - come back after or not responded to an infusion of your own healthy stem cells into your body (autologous stem cell transplant), or - co Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT ADCETRIS 50 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 50 mg of brentuximab vedotin. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. ADCETRIS is an antibody-drug conjugate composed of a CD30-directed monoclonal antibody (recombinant chimeric immunoglobulin G1 [IgG1], produced by recombinant DNA technology in Chinese Hamster ovary cells) that is covalently linked to the antimicrotubule agent monomethyl auristatin E (MMAE). Excipient with known effect Each vial contains approximately 13.2 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hodgkin lymphoma ADCETRIS is indicated for adult patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma (HL) in combination with doxorubicin, vinblastine and dacarbazine (AVD) (see sections 4.2 and 5.1). ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following autologous stem cell transplant (ASCT) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following ASCT, or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. Systemic anaplastic large cell lymphoma ADCETRIS in combination with cyclophosphamide, doxorubicin and prednisone (CHP) is indicated for adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) (see section 5.1). ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory sALCL. 3 Cutaneous T-cell lymphoma ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior Izlasiet visu dokumentu