Benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving standard therapy. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. Final appraisal determination belimumab for the treatment of active autoantibodypositive systemic lupus erythematosus issue date. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour.
April 2012 each of the bliss trials were threearm trials belimumab 10 mgkg, belimumab 1 mgkg and placebo, only results for the 10 mgkg belimumab dose were presented in the manufacturers. Gsk receives chmp positive opinion for selfinjectable formulation of benlysta for systemic lupus erythematosus. Site of care utilization management policy applies to belimumab benlysta. It is given as an infusion into a vein over a period of time. Belimumab, a prescription medication, is approved for the treatment of lupus. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development. Limitations of use the efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. When belimumab was approved in march 2011, the indication section of the package insert stated and still stands when most recently revised in april 2014. Do not use belimumab if it has been left at room temperature longer than 12 hours. Learn about ocrevus ocrelizumab, a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis. By binding blys, benlysta allows more b cells to undergo the normally occurring process of apoptosis, which inhibits the survival of b cells, including autoreactive b cells and reduces the differentiation of b cells into immunoglobulin.
Benlysta belimumab is indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving standard therapy. Belimumab is a monoclonal antibody that affects the actions of the bodys immune system. Type 1 glass vials 5 ml, sealed with a siliconised chlorobutyl rubber stopper and a flipoff aluminum seal containing 120 mg of powder. Successful treatment of a mycophenolate mofetilrefractory. Fda clears selfinjectable belimumab benlysta for sle. Jan 17, 2020 belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. Fda questions safety, efficacy of belimumab medpage today. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation. 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. Talk to your doctor about benlysta for more information. Belimumab is a monoclonal antibody against soluble blymphocyte stimulator, an essential growth factor for bcell maturation and activation, which was approved by the us fda in 2011 for patients. Objective to investigate the efficacy and safety of belimumab.
First approved lupus treatment option benlysta belimumab. Belimumab is a human igg1 neutralizing monoclonal antibody against blymphocyte stimulating factor also known as blymphocyte stimulator blys. Based on the clinical trials, belimumab appears to be generally well tolerated, although safety concerns were raised for hypersensitivity, infections, depression, and overall mortality. Belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. Take the package out of the refrigerator to let the medicine reach room temperature for 30 minutes before injecting your dose. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Sep, 2019 how is this medicine belimumab vials best taken. For precertification of belimumab benlysta, call 866 7527021, or fax 866 2673277.
Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus. The feature directory provides a convenient quick reference list for 12 features. Gsk receives chmp positive opinion for selfinjectable. Benlysta isindicated for the treatment of adult patients with active, autoantibody positive systemic lupus erythematosus who are receiving standard therapy. Xgeva is indicated for the prevention of skeletalrelated events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 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. Benlysta 400 mg powder for concentrate for solution for infusion.
Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development and sle pathogenesis. Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus sle. The recommended dosage is 200 mg once weekly given as a subcutaneous injection in the abdomen or thigh. Benlysta package insert pdf keyword found websites. Belimumab is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus. Belimumab treatment holiday and treatment restart study in lupus patients the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Learn about benlysta belimumab, a treatment option that may be right for you. It is approved in the united states, canada, and europe to treat systemic lupus erythematosus sle.
Signs and symptoms of inflammation may be lessened due to suppression from belimumab. Belimumab is used to treat active systemic lupus erythematosus in adults. The effect of belimumab on the reduction of sle disease activity or flares was not significant. Benlysta 120 mg powder for concentrate for solution for. Benlysta belimumab for injection, for intravenous use only initial u. Merrill jt1, ginzler em, wallace dj, mckay jd longterm safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus. Benlysta package insert pdf keyword after analyzing the system lists the list of keywords related and the list of websites with related content, in addition you can see which keywords most interested customers on the this website. Efficacy and safety of belimumab in patients with active.
Belimumab assessment of safety in sle full text view. Belimumab trade name benlysta, previously known as lymphostatb is a human monoclonal antibody that inhibits bcell activating factor baff, also known as blymphocyte stimulator blys. Benlysta should not be infused concomitantly in the same intravenous line with other agents. What should i discuss with my healthcare provider before using belimumab.
Ten has been reported for rituximab see rituximab package insert. Benlysta is a blymphocyte stimulator blys specific inhibitor indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus who are receiving standard therapy. Biologic activity and safety of belimumab, a neutralizing antiblymphocyte stimulator blys monoclonal antibody. Common and rare side effects for benlysta intravenous. Highlights of prescribing information these highlights do. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus.
Avaya 6402d manual pdf the feature directory provides a convenient quick reference list for 12 features. Benlysta belimumab for injection, for intravenous use and subcutaneous use. The indications below including fdaapproved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy. 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.
Belimumab showed encouraging results in openlabel phase ii study of patients with primary sjogrens syndrome. You may inject belimumab injection on the front of the thighs or anywhere on your stomach except your navel belly button and the area 2 inches around it. Other drugs may be given before this medicine belimumab vials to help avoid side effects. Listing a study does not mean it has been evaluated by the u. The solution should be clear to opalescent and colorless to pale yellow.
Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. Belimumab treatment holiday and treatment restart study in. Benlysta belimumab is the first and only approved treatment designed for lupus sle or systemic lupus erythematosus. Per package insert, the efficacy of benlysta has not been evaluated in patients with severe.
Most likely, the feature directory on your voice terminal has been. Parts of the body affected by sle include the heart, skin, joints, kidneys, lungs, and brain. Benlysta 120 mg powder for concentrate for solution for infusion. This global belimumab pregnancy registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus sle who have received commercially supplied belimumab within the 4 months prior to andor during pregnancy. Systemic lupus erythematosus sle is a chronic inflammatory disorder that is driven by autoantibodies that target multiple organ systems. What are the possible side effects of belimumab benlysta, benlysta autoinjector. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women. Benlysta belimumab side effects, images, uses, dosage. Efficacy and safety of subcutaneous belimumab in antidouble. However, you can edit the pdf itself in word for the web, which lets you update the pdf s content, or copy and paste content from the pdf into a word document. Delayedtype, nonacute hypersensitivity reactions have also been observed and. Belimumab side effects, dosage, interactions drugs.
Nov 09, 2018 belimumab is a monoclonal antibody that affects the actions of the bodys immune system. The authors concluded that belimumab was biologically active and welltolerated. However, serologically active sle patients responded significantly better to belimumab therapy plus soc than to soc alone. This emedtv segment explains what this means and offers information on what the drugs manufacturer recommends and how this product performed in animal studies.
Benlysta belimumab for injection, for intravenous use only. Among patients treated with belimumab 10mgkg in addition to standard therapy, 58% had selenasledai scores reduced by. This emedtv article explains the uses of belimumab in greater detail, with information on who can use this drug and what type of lupus it can treat. Find information about common, infrequent and rare side effects of benlysta intravenous. Highlights of prescribing information these highlights do not.
Feb 03, 2020 benlysta belimumab for injection, for intravenous use and subcutaneous use. Benlysta belimumab for injection is a sterile, white to offwhite, preservative. Evidencebased recommendations on belimumab benlysta as an addon treatment for active autoantibodypositive systemic lupus erythematosus in adults there is a managed access agreement, which sets out the conditions for availability of belimumab guidance development process. Highlights of prescribing information these highlights do not include all the information needed to use benlysta safely and effectively. Monoclonal antibodies are made to target and destroy only. Belimumab significantly improved the response rate, reduced disease activity and severe flares, and was well tolerated. Use this medicine belimumab vials as ordered by your doctor. Belimumab benlysta pregnancy registry full text view. 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. If a new infection develops, consider interrupting belimumab therapy and monitor the patient closely. Use caution when considering belimumab in patients with chronic infections.
Belimumab for the treatment of active autoantibody. An indirect comparison of intravenous and subcutaneous. Most likely, the feature directory on your voice terminal has been completed by. The efficacy and safety of iv belimumab has been demonstrated in. Pdf belimumab therapy for systemic lupus erythematosus and. Cases of stevensjohnson syndrome sjs and ten, some fatal, have been reported when treanda was administered concomitantly with allopurinol and other medications known to cause these syndromes. Early disease and low baseline damage predict response to. Precertification of belimumab benlysta is required of all aetna participating providers and members in applicable plan designs. This may help to protect healthy cells from damage. Belimumab definition of belimumab by medical dictionary. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women with sle. The fda has given benlysta belimumab a pregnancy category c rating.
Monoclonal antibodies are made to target and destroy only certain cells in the body. Article pdf available in drug development research 727 november 2011 with 195 reads. The us food and drug administration fda has approved a new subcutaneous formulation of belimumab benlysta. Word for the web doesnt let you insert objects, such as pdfs, into a document. Welcome to the leading independent provider of fda approved medication information, delivering the latest package inserts and product labels directly from the fda repository in an easytoread format. What is the most important information i should know about belimumab benlysta, benlysta autoinjector. Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication. Do not put the medicine back into the refrigerator. Study participants receive standard therapy for sle in addition to receiving the study drug, either placebo no active medicine or belimumab.
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