Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
belimumab
GlaxoSmithKline (Ireland) Limited
L04AA26
belimumab
Immunosuppressants
Lupus Erythematosus, Systemic
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti dsDNA and low complement) despite standard therapy.Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.
Revision: 31
Authorised
2011-07-13
68 B. PACKAGE LEAFLET 69 PACKAGE LEAFLET: INFORMATION FOR THE USER BENLYSTA 200 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN belimumab 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 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. - 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. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Benlysta is and what it is used for 2. What you need to know before you use Benlysta 3. How Benlysta is used 4. Possible side effects 5. How to store Benlysta 6. Contents of the pack and other information Step-by-step instructions for using the pre-filled pen 1. WHAT BENLYSTA IS AND WHAT IT IS USED FOR BENLYSTA AS A SUBCUTANEOUS INJECTION IS A MEDICINE USED TO TREAT LUPUS (systemic lupus erythematosus, SLE) in adults (18 years of age and older) whose disease is still highly active despite standard treatment. Benlysta is also used in combination with other medicines to treat adults with active lupus nephritis (lupus-related kidney inflammation). Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage. It can affect almost any organ in the body, and is thought to involve a type of white blood cells called _B cells_ . Benlysta contains BELIMUMAB ( _a monoclonal antibody_ ). It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in pe Lestu allt skjalið
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 Benlysta 200 mg solution for injection in pre-filled pen. Benlysta 200 mg solution for injection in pre-filled syringe. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Pre-filled pen Each 1-mL pre-filled pen contains 200 mg of belimumab. Pre-filled syringe Each 1-mL pre-filled syringe contains 200 mg of belimumab. Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (injection) Solution for injection in pre-filled syringe (injection) A clear to opalescent, colourless to pale yellow solution, with a pH of 6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy (see section 5.1). Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. It is recommended that the first subcutaneous injection of Benlysta should be under the supervision of a healthcare professional in a setting that is sufficiently qualified to manage hypersensitivity reactions, if necessary. The healthcare professional mu Lestu allt skjalið