Belimumab package insert pdf

First approved lupus treatment option benlysta belimumab. Added anaphylaxis with prior benlysta administration as. This leaflet is part iii of a threepart product monograph. Humira adalimumab is a recombinant human igg1 monoclonal antibody specific for human tumor necrosis factor tnf. Insert the entire needle into the pinched area of the skin at a slight degree angle using a.

Benlysta is a blymphocyte stimulator blysspecific inhibitor indicated for the treatment of adult patients with active, autoantibodypositive, systemic. Insert the entire needle into the pinched area of the skin at. Beleodaq is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral tcell lymphoma ptcl. Biologic activity and safety of belimumab, a neutralizing antiblymphocyte stimulator blys monoclonal antibody. Belimumab is a monoclonal antibody that affects the actions of the bodys immune system. Belimumab can also be given as an injection under the skin subcutaneous injection. Not to be copied, reproduced or distributed without the expressed prior knowledge, consent and permission of avmed. Restricted access do not disseminate or copy without approval. Benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active, autoantibodypositive, systemic lupus erythematosus sle. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus. Humira adalimumab, abbott laboratories package insert.

Delayedtype, nonacute hypersensitivity reactions have also been observed and included symptoms such. The effect of belimumab on the reduction of sle disease activity or flares was not significant. Benlysta belimumab is indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving. Systemic lupus erythematosus sle is a chronic inflammatory disorder that is driven by autoantibodies that target multiple organ systems. Chapter 7a prescription medications prior authorization number. If a new infection develops, consider interrupting belimumab therapy and monitor the patient closely. Benlysta belimumab is a fully human igg1 monoclonal antibody specific for soluble human b. Benlysta belimumab is the first and only approved treatment designed for lupus sle or systemic lupus erythematosus. See full prescribing information including boxed warning on serious infections. Keep in the original package until time of use to protect from light. Benlysta belimumab for injection, for intravenous use. These have been observed with benlysta in clinical trials.

Benlysta offers the independence of a weekly selfinjection in the comfort of your own home at a time that is convenient for youafter youve been trained by a healthcare provider. Benlysta belimumab for injection, for intravenous use only. Belimumab package insert pdf belimumab has been studied in a limited number of sle patients with renal syringe are provided at the end of. An improvement in survival or diseaserelated symptoms has not been established. Continued approval for this indication may be contingent. Page 2 of 21 full prescribing information 1 indications and usage 1. However, serologically active sle patients responded significantly better to belimumab therapy plus soc than to soc alone. While in the circulation, simulect impairs the response of the immune system to antigenic. Because of its mechanism of action, belimumab may interfere with the response to. Anaphylaxis has occurred as early as after the first dose of xolair, but. To fully understand how to use your medication safely and effectively, talk to your doctor, and watch the entire videos below on the autoinjector and prefilled. Benlysta belimumab for injection, for intravenous use benlysta belimumab. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.

Highlights of prescribing information these highlights do. Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus sle. Patients with a history of multiple drug allergies or significant. Benlysta belimumab autoinjectors and prefilled syringes. Learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Bcg infections have been reported in health care workers, primarily from exposures. Talk to your doctor about benlysta for more information. Humira is produced by recombinant dna technology in a mammalian cell expression system and is. These highlights do not include all the information needed to use benlysta safely and effectively. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. Belimumab package insert pdf belimumab has been studied in a limited number of sle patients with renal syringe are provided at the end of the package leaflet see stepbystep. Belimumab is given in a health care providers office, a hospital, or an infusion center by an administration of the medication directly into a vein infusion. Learn more about benlysta belimumab for subcutaneous use.

Benlysta belimumab injection, for subcutaneous use initial u. Monoclonal antibodies are made to target and destroy only. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development and sle pathogenesis. Belimumab benlysta pregnancy registry the belimumab benlysta pregnancy registry is a prospective cohort study that enrolls women with systemic lupus erythematosus sle who have been given exposed to commerciallysupplied belimumab within the 4 months prior to andor during pregnancy. Highlights of prescribing information these highlights do not include all the information needed to use zinplavasafely and effectively. Belimumab can be given as an infusion or injection. Highlights of prescribing information these highlights do not include all the information needed to use benlysta safely and effectively. If you are an adult, benlysta can be taken by injection.

In addition, pregnancy and infant outcomes will also be collected for pregnancies in women. Humira was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human igg1. This indication is approved under accelerated approval based on tumor response rate and duration of response. Anaphylaxis anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, andor angioedema of the throat or tongue, has been reported to occur after administration of xolair. Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Use caution when considering belimumab in patients with chronic infections. Belimumab side effects, dosage, interactions drugs. Delayedtype, nonacute hypersensitivity reactions have also been observed and included symptoms such as rash, nausea, fatigue, myalgia, headache, and facial. Highlights of prescribing information these highlights do not include all the information needed to use avastin safely and effectively. Keep taking benlysta belimumab autoinjectors and prefilled syringes as you have been told by your doctor or other health care provider, even if you feel well. The authors concluded that belimumab was biologically active and welltolerated.