Belimumab is given as an infusion into a vein, usually every 2 to 4 weeks. Belimumab showed encouraging results in openlabel phase ii study of patients with primary sjogrens syndrome. Belimumab comes as a powder to be mixed into a solution to be injected intravenously into a vein in adults and children 5 years of age and older. Benlysta 120 mg and 400 mg powder for concentrate for. Belimumab benlysta is a targeted, human monoclonal antibody that binds to soluble b lymphocyte stimulator blys. Belimumab, a prescription medication, is approved for the treatment of lupus. Restricted access do not disseminate or copy without approval. This emedtv segment explains what this means and offers information on what the drugs manufacturer recommends and how this product performed in animal studies. Early disease and low baseline damage predict response to. Benlysta belimumab solution for subcutaneous injection fda. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation.
Belimumab phase i study in chinese subjects with systemic. Dailymed benlysta belimumab injection, powder, lyophilized. Belimumab for injection is a sterile, white to offwhite, preservativefree, lyophilized powder in a singledose vial for reconstitution and dilution prior to intravenous infusion. Jan 27, 2020 how is this medicine belimumab vials best taken. It is a specific inhibitor of the soluble blymphocyte stimulator blys cytokine, which has been implicated in the pathogenesis of systemic lupus erythematosus sle. Pdf a randomized, openlabel study to investigate the effect of. Do not administer as an intravenous push or bolus 2. Belimumab is an injected drug that helps reduce symptoms of lupus by suppressing the immune system. The medicine must be given slowly, and the infusion can take about 1.
The belimumab final drug product for intravenous iv use has utilised 2 formulations during its clinical history. Detailed belimumab dosage information for adults and children. Benlysta is a prescription medication used to treat patients with active systemic lupus erythematosus sle or lupus who are receiving other lupus medicines. Benlysta belimumab side effects, images, uses, dosage. In china, belimumab gsk1550188 will be developed for a dosing regimen of oncemonthly intravenous iv infusion for the treatment of sle.
Belimumab for the treatment of active autoantibody. It is approved in the united states, canada, and europe to treat systemic lupus erythematosus sle. Belimumab benlysta medical clinical policy bulletins aetna. Pdf objective intravenous belimumab 10 mgkg is approved as an addon therapy in patients with active. Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Nov 09, 2018 belimumab is given as an infusion into a vein, usually every 2 to 4 weeks.
Benlysta sq belimumab prior auth criteria proprietary information. Monoclonal antibodies are made to target and destroy only certain cells in the body. Pdf efficacy of novel monoclonal antibody belimumab in the. Belimumab in formulation buffer 06 a was used in phase i and ii clinical studies while formulation b uffer 06b was used for phase iii clinical studies and. C indications treatment of active autoantibodypositive systemic lupus erythematosus sle in patients currently receiving standard therapy. Clinical trials of various phases have indicated that belimumab is beneficial for patients with sle furie et. Belimumab for the treatment of active autoantibodypositive systemic lupus erythematosus this guidance was developed using the single technology appraisal sta process. It is given as an infusion into a vein over a period of time. Insert the entire needle into the pinched area of the skin at a slight 45degree angle using a dartlike motion.
This openlabel, single dose study will evaluate the safety, tolerability, pharmacokinetics pk and pharmacodynamics pd of belimumab in chinese sle subjects. The fda has given benlysta belimumab a pregnancy category c rating. Word format that includes the changes approved in this. Apr 21, 2014 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. Belimumab is contraindicated in patients with active infection. Belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. Benlysta belimumab is indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus sle who are receiving standard therapy. Benlysta 400 mg powder for concentrate for solution for infusion. This emedtv web selection provides important dosing tips, side effect information, safety warnings, and more. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, a cough that does not go away, or signs of herpes such as cold. Use this medicine belimumab vials as ordered by your doctor.
This inhibits the survival of b cells and reduces the differentiation of b cells into immunoglobulinproducing plasma cells. Belimumab does not bind b cells directly, but by binding blys, belimumab inhibits the survival of b cells, including autoreactive b cells, and reduces the differentiation of b cells into immunoglobulinproducing plasma cells. The recommended dosage is 200 mg once weekly given as a subcutaneous injection in the abdomen or thigh. How to access a pdf or word document large file warning. 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. Sle disease activity did not change after 1 or 2 doses of belimumab. Gently invert the bag or bottle to mix the solution.
Early disease and low baseline damage predict response to belimumab in patients with. Belimumab is the only approved biological agent for the treatment of systemic lupus erythematosus sle. Belimumab is not compatible with dextrosecontaining solutions. It is strongly recommended you download this document to your own computer and open from there. Do not use belimumab if it has been left at room temperature longer than 12 hours. Hold the prefilled syringe in one hand and use your free hand to gently pinch the skin around the injection site. Gsk receives chmp positive opinion for selfinjectable. Belimumab side effects, dosage, interactions drugs. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women with sle.
Benlysta belimumab for injection is a sterile, white to offwhite, preservative. Baff, belimumab, blys, lupus nephritis, monoclonal antibody. Then add the required volume of the reconstituted solution of benlysta into the infusion bag or bottle. The 52week study, also known as bliss52 a study of belimumab in subjects with systemic lupus erythematosus, enrolled 865 patients in countries outside north america latin america, asia pacific, and eastern europe and randomized patients with active lupus to intravenous belimumab 10 mgkg, 1 mgkg, or placebo in addition to their. Type 1 glass vials 5 ml, sealed with a siliconised chlorobutyl rubber stopper and a flipoff aluminum seal containing 120 mg of powder. Gsk today announced that the european medicines agencys committee for medicinal products for human use chmp has issued a positive opinion recommending approval for a new subcutaneous formulation of benlysta belimumab as an addon therapy in adult patients with active autoantibodypositive systemic lupus erythematosussle with a high. Belimumab definition of belimumab by medical dictionary. Dont take if you have an infection belimumab can make it harder for you to fight off infections. 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. This openlabel, single dose study will evaluate the safety, tolerability, pharmacokinetics pk and pharmacodynamics pd.
Take the package out of the refrigerator to let the medicine reach room temperature for 30 minutes before injecting your dose. Ocrevus increases your risk of getting upper respiratory tract infections, lower respiratory tract infections, skin infections, and herpes infections. Benlysta belimumab dose, indications, adverse effects. 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. Intravenous dosing of benlysta is approved for adults and children aged 5 years and older. When belimumab was approved in march 2011, the indication section of the package insert stated and still stands when most recently revised.
Listing a study does not mean it has been evaluated by the u. Signs and symptoms of inflammation may be lessened due to suppression from belimumab. Other drugs may be given before this medicine belimumab vials to help avoid side effects. Belimumab also comes as a solution liquid in an autoinjector or prefilled syringe to inject subcutaneously under the skin in adults. It is hypothesized that an abnormal level of b cells is a mechanism of action. Highlights of prescribing information these highlights do not. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Parts of the body affected by sle include the heart, skin, joints, kidneys, lungs, and brain. In addition, pregnancy and infant outcomes will also be collected for pregnancies in women. Belimumab is a blymphocyte stimulator protein inhibitor that is thought to decrease the amount of abnormal b cells. Any unused solution in the vials must be discarded. A healthcare provider will give you this injection.
Attempting to open large files over the internet within the browser window may cause problems. Belimumab is the first biologic therapy to be licensed and approved by the united states food and drug administration fda and the european medicines evaluation agency emea for use in. This emedtv web selection provides important dosing. Protect from light and do not shake or heat the medicine. Aug 26, 2016 in china, belimumab gsk1550188 will be developed for a dosing regimen of oncemonthly intravenous iv infusion for the treatment of sle. Action a monoclonal antibody produced by recombinant dna. Belimumab treatment holiday and treatment restart study. Serious and sometimes fatal infections can occur in patients receiving benlysta. Read the medication guide and instructions for use provided by your pharmacist before you start using belimumab and each time you get a refill. Serious and sometimes fatal infections have been reported in patients receiving. 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. Pdf recently introduced into the market, belimumab benlysta is a monoclonal antibody that has potential. 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. Belimumab assessment of safety in sle full text view.
Fda questions safety, efficacy of belimumab medpage today. Let your doctor know if you are planning to get pregnant or if you are breastfeeding. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus. For patients weighing 40 kg or less, 100 ml may be used as long as the concentration in the infusion bag does not exceed 4 mgml. Feb 03, 2020 what is belimumab benlysta, benlysta autoinjector. Do not put the medicine back into the refrigerator.
Belimumab treatment holiday and treatment restart study in. Belimumab is a monoclonal antibody that affects the actions of the bodys immune system. Objective to investigate the efficacy and safety of belimumab, a human. First approved lupus treatment option benlysta belimumab.
Belimumab does not bind to b cells directly but blocks access of soluble blys to its receptors on b cells. Efficacy and safety of subcutaneous belimumab in antidouble. Etiologies included infection, cardiovascular disease and suicide. Belimumab is a blysspecific inhibitor that blocks the binding of soluble blys, a bcell survival factor, to its receptors on b cells. Study participants receive standard therapy for sle in addition to receiving the study drug, either placebo no active medicine or belimumab. Fda clears selfinjectable belimumab benlysta for sle. Jan 17, 2020 belimumab is produced by recombinant dna technology in a murine cell ns0 expression system. 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. Belimumab benlysta, which recently received marketing approval, is the first of a new class of immunomodulators with a novel mechanism of action. Addon therapy in adult patients with active, autoantibodypositive systemic lupus erythematosus sle with a high degree of disease activity e. Abstract objective to investigate predictors of response, remission, low disease activity lda, damage and drug discontinuation in patients with systemic lupus. Based on the clinical trials, belimumab appears to be generally well tolerated, although safety concerns were raised for hypersensitivity, infections, depression, and overall mortality.
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