Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Elotuzumab
Bristol-Myers Squibb Pharma EEIG
L01FX08
elotuzumab
Antineoplastic agents
Multiple Myeloma
Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1).
Revision: 12
Authorised
2016-05-11
37 B. PACKAGE LEAFLET 38 PACKAGE LEAFLET: INFORMATION FOR THE USER EMPLICITI 300 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION EMPLICITI 400 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION elotuzumab 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, or pharmacist or nurse. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Empliciti is and what it is used for 2. What you need to know before you use Empliciti 3. How to use Empliciti 4. Possible side effects 5. How to store Empliciti 6. Contents of the pack and other information 1. WHAT EMPLICITI IS AND WHAT IT IS USED FOR Empliciti contains the active substance elotuzumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body. Elotuzumab attaches to a target protein called SLAMF7. SLAMF7 is found in large amounts on the surface of multiple myeloma cells and on certain cells of your immune system (natural killer cells). When elotuzumab binds to SLAMF7 on the multiple myeloma or natural killer cells, it stimulates your immune system to attack and destroy the multiple myeloma cells. Empliciti is used to treat multiple myeloma (a cancer of the bone marrow) in adults. Empliciti will be given to you together with lenalidomide and dexamethasone or together with pomalidomide and dexamethasone. Multiple myeloma is a cancer of a type of white blood cell called plasma cells. These cells divide out of control and collect in the bone marrow. This results in damage to the bones and kidneys. Empliciti is used if your cancer has not responded to, or has come back after certain treatments. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE EMPLICITI YOU SHOULD NOT BE GIVEN EMPLICITI if you are allergic t Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Empliciti 300 mg powder for concentrate for solution for infusion. Empliciti 400 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Empliciti 300 mg powder for concentrate for solution for infusion Each vial of powder contains 300 mg elotuzumab*. Empliciti 400 mg powder for concentrate for solution for infusion Each vial of powder contains 400 mg elotuzumab. After reconstitution, each mL of concentrate contains 25 mg elotuzumab. * Elotuzumab is produced in NS0 cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion (powder for concentrate). The powder is white to off white whole or fragmented cake. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Empliciti is indicated in combination with lenalidomide and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy (see sections 4.2 and 5.1). Empliciti is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Elotuzumab therapy should be initiated and supervised by physicians experienced in the treatment of multiple myeloma. Premedication for prevention of infusion related reactions (IRRs) Patients must be administered with the following premedications 45-90 minutes prior to Empliciti infusion (see section 4.4): Dexamethasone 8 mg intravenous H1 blocker: diphenhydramine (25-50 mg orally or intravenous) or equivalent H1 blocker. H2 blocker: ranitidine (50 mg intravenous or 150 mg orally) or equivalent H2 blocker. Paracetamol (650-1000 mg orally). Management Przeczytaj cały dokument