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. For precertification of belimumab benlysta, call 866 7527021, or fax 866 2673277. Parts of the body affected by sle include the heart, skin, joints, kidneys, lungs, and brain. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Monoclonal antibodies are made to target and destroy only. This may help to protect healthy cells from damage. Site of care utilization management policy applies to belimumab benlysta. Find information about common, infrequent and rare side effects of benlysta intravenous. Ten has been reported for rituximab see rituximab package insert.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation. 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. Fda questions safety, efficacy of belimumab medpage today. The efficacy and safety of iv belimumab has been demonstrated in. 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. Type 1 glass vials 5 ml, sealed with a siliconised chlorobutyl rubber stopper and a flipoff aluminum seal containing 120 mg of powder. Highlights of prescribing information these highlights do not. Objective to investigate the efficacy and safety of belimumab. Merrill jt1, ginzler em, wallace dj, mckay jd longterm safety profile of belimumab plus standard therapy in patients with systemic lupus erythematosus.
Benlysta belimumab is the first and only approved treatment designed for lupus sle or systemic lupus erythematosus. 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. The authors concluded that belimumab was biologically active and welltolerated. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour. Pdf belimumab therapy for systemic lupus erythematosus and. Efficacy and safety of subcutaneous belimumab in antidouble. Based on the clinical trials, belimumab appears to be generally well tolerated, although safety concerns were raised for hypersensitivity, infections, depression, and overall mortality. This emedtv segment explains what this means and offers information on what the drugs manufacturer recommends and how this product performed in animal studies.
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. Gsk receives chmp positive opinion for selfinjectable formulation of benlysta for systemic lupus erythematosus. If a new infection develops, consider interrupting belimumab therapy and monitor the patient closely. Sep, 2019 how is this medicine belimumab vials best taken. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Study participants receive standard therapy for sle in addition to receiving the study drug, either placebo no active medicine or belimumab. The recommended dosage is 200 mg once weekly given as a subcutaneous injection in the abdomen or thigh. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development. 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. 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.
Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication. Efficacy and safety of belimumab in patients with active. An indirect comparison of intravenous and subcutaneous. Benlysta 400 mg powder for concentrate for solution for infusion. 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. Do not put the medicine back into the refrigerator. The effect of belimumab on the reduction of sle disease activity or flares was not significant. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women with sle. Benlysta belimumab is indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving standard therapy. Belimumab significantly improved the response rate, reduced disease activity and severe flares, and was well tolerated. Protect from light and do not shake or heat the medicine.
Belimumab is contraindicated in patients with active infection. Learn about ocrevus ocrelizumab, a prescription medicine used to treat adults with relapsing or primary progressive multiple sclerosis. Benlysta belimumab for injection is a sterile, white to offwhite, preservative. 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. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. It is approved in the united states, canada, and europe to treat systemic lupus erythematosus sle. 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. Systemic lupus erythematosus sle is a chronic inflammatory disorder that is driven by autoantibodies that target multiple organ systems.
Belimumab treatment holiday and treatment restart study. Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus sle. Article pdf available in drug development research 727 november 2011 with 195 reads. Gsk receives chmp positive opinion for selfinjectable. Overview belimumab for treating active autoantibody. Precertification of belimumab benlysta is required of all aetna participating providers and members in applicable plan designs.
Belimumab is used with other medications to treat certain types of systemic lupus erythematosus sle or lupus. Belimumab is a monoclonal antibody that affects the actions of the bodys immune system. Belimumab benlysta is a targeted, human monoclonal antibody that binds to soluble b lymphocyte stimulator blys. However, serologically active sle patients responded significantly better to belimumab therapy plus soc than to soc alone. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus. 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. The us food and drug administration fda has approved a new subcutaneous formulation of belimumab benlysta. 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. Signs and symptoms of inflammation may be lessened due to suppression from belimumab. When belimumab was approved in march 2011, the indication section of the package insert stated and still stands when most recently revised. Belimumab benlysta medical clinical policy bulletins aetna.
Use caution when considering belimumab in patients with chronic infections. Talk to your doctor about benlysta for more information. Use this medicine belimumab vials as ordered by your doctor. Early disease and low baseline damage predict response to. What are the possible side effects of belimumab benlysta, benlysta autoinjector.
It is given as an infusion into a vein over a period of time. Learn about benlysta belimumab, a treatment option that may be right for you. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women. Most likely, the feature directory on your voice terminal has been completed by. 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. Do not use belimumab if it has been left at room temperature longer than 12 hours. Delayedtype, nonacute hypersensitivity reactions have also been observed and. Word for the web doesnt let you insert objects, such as pdfs, into a document. Avaya 6402d manual pdf the feature directory provides a convenient quick reference list for 12 features. The package leaflet should be provided to the patient each time benlysta is administered. The fda has given benlysta belimumab a pregnancy category c rating. 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. Belimumab showed encouraging results in openlabel phase ii study of patients with primary sjogrens syndrome. Dailymed benlysta belimumab injection, powder, lyophilized.
Successful treatment of a mycophenolate mofetilrefractory. Belimumab is a human igg1 neutralizing monoclonal antibody against blymphocyte stimulating factor also known as blymphocyte stimulator blys. August 11, 2019 august 11, 2019 leave a comment on avaya 6402d manual pdf. 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. Jan 17, 2020 belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. Belimumab benlysta pregnancy registry full text view. Per package insert, the efficacy of benlysta has not been evaluated in patients with severe. The solution should be clear to opalescent and colorless to pale yellow. Belimumab assessment of safety in sle full text view. Final appraisal determination belimumab for the treatment of active autoantibodypositive systemic lupus erythematosus issue date. Benlysta belimumab for injection, for intravenous use only. Benlysta belimumab for injection, for intravenous use and subcutaneous use.
Belimumab, a prescription medication, is approved for the treatment of lupus. Belimumab is used to treat active systemic lupus erythematosus in adults. Benlysta 120 mg powder for concentrate for solution for infusion. 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. Highlights of prescribing information these highlights do not include all the information needed to use benlysta safely and effectively. Among patients treated with belimumab 10mgkg in addition to standard therapy, 58% had selenasledai scores reduced by. Belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. Highlights of prescribing information these highlights do.
Fda clears selfinjectable belimumab benlysta for sle. 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. Other drugs may be given before this medicine belimumab vials to help avoid side effects. Benlysta package insert pdf keyword found websites.
What should i discuss with my healthcare provider before using belimumab. The feature directory provides a convenient quick reference list for 12 features. Biologic activity and safety of belimumab, a neutralizing antiblymphocyte stimulator blys monoclonal antibody. Benlysta 120 mg powder for concentrate for solution for. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. 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. Xgeva is indicated for the prevention of skeletalrelated events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Belimumab side effects, dosage, interactions drugs.
Belimumab is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus. 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. 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. Take the package out of the refrigerator to let the medicine reach room temperature for 30 minutes before injecting your dose. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus.
Listing a study does not mean it has been evaluated by the u. Belimumab definition of belimumab by medical dictionary. Benlysta isindicated for the treatment of adult patients with active, autoantibody positive systemic lupus erythematosus who are receiving standard therapy. Benlysta belimumab for injection, for intravenous use only initial u. Most likely, the feature directory on your voice terminal has been.
Benlysta belimumab for injection, for intravenous use. Belimumab treatment holiday and treatment restart study in. Common and rare side effects for benlysta intravenous. 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. Feb 03, 2020 benlysta belimumab for injection, for intravenous use and subcutaneous use. Benlysta belimumab side effects, images, uses, dosage. Blymphocyte stimulator blys and its receptors on bcell subsets play an important role in autoimmune bcell development and sle pathogenesis. Nov 09, 2018 belimumab is a monoclonal antibody that affects the actions of the bodys immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. First approved lupus treatment option benlysta belimumab.
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