Benlysta may be administered as an intravenous infusion in. The package leaflet should be available to the patient. Does the patient have either of these active conditions. Trademarks are owned by or licensed to the gsk group of companies. These have been observed with benlysta in clinical trials. The product information is intended to assist healthcare professionals make decisions about treatment options and provide advice on the appropriate use of a medicine to patients. Benlysta sq belimumab prior auth criteria proprietary information. Seek emergency medical attention or call the poison help line at 18002221222.
Highlights of prescribing information an initial dose of 600. In trial 2 at 76 weeks, benlysta 10mgkg did not have a significant sri compared to placebo. Mar 04, 2020 benlysta is used together with other lupus medicines to treat active systemic lupus erythematosus sle. Local coverage determinations lcds do not exist at this time. Added anaphylaxis with prior benlysta administration as. Highlights of prescribing information these highlights do not include all the information needed to use dupixent safely and effectively.
Benlysta belimumab side effects, images, uses, dosage. Every individual package label entry contains a unique identifier which can be used to secure further details directly from. Keep in the original package until time of use to protect from light. Highlights of prescribing information these highlights do not include all the information needed to use rituxan hycela safely and effectively. Learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Rituxan hycela rituximab and hyaluronidase human injection, for subcutaneous use initial u. Use nulojix only in patients who are epsteinbarr virus ebv seropositive. Benlysta belimumab injection, for subcutaneous use initial u. It is usually given every two weeks for the first three doses and then once a month. These highlights do not include all the information needed to use benlysta safely and effectively. The information was added in the codes section as the following. Restricted access do not disseminate or copy without approval.
Many different factors affect your dose of benlysta. Read the instructions for use that come with benlysta to learn the proper way inject yourself at home. Watch the rituxan hycela rituximabhyaluronidase human dosing and administration video for hcps. This may help to protect healthy cells from damage. Dosing limits max units per dose and over time medical benefit.
May 17, 2019 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. Benlysta belimumab for injection, for intravenous use only initial u. This site is intended for us healthcare professionals only. The efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Tell your doctor at once if you develop signs of infection. Learn about drug imprint, side effects, uses treating, dosage, interaction, overdose, and warnings. Belimumab benlysta is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus sle. What should i avoid while using belimumab benlysta, benlysta autoinjector. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation. Caution should be exercised if benlysta is coadministered with other b cell targeted therapy or cyclophosphamide. Length of authorization coverage will be provided for 12 months and may be renewed.
Monitor patients during and for an appropriate period of time after administration of benlysta. Nonerosive arthritis involving 2 or more peripheral joints 6. These highlights do not include all the information needed to use. If you are a new user to the site, please click the register now button to begin the registration process. Use benlysta exactly as your healthcare provider tells you to. Benlysta belimumab vials are covered under the medical benefit. Is benlysta being prescribed by or in consultation with a rheumatologist. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases. Medicare does not have a national coverage determination ncd for benlysta belimumab. Cerezyme is the only ert enzyme replacement therapy that has shown longterm efficacy and safety in multiple studies over 10 years and has been prescribed for over 20 years learn more about cerezyme and talk to your doctor to see if cerezyme is right for you. Highlights of prescribing information adequately rehydrate. Benlysta iv belimumab prior auth criteria proprietary information.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. Administer aggressive intravenous hydration and antihyperuricemic therapy in patients at high risk for tls. Take the package out of the refrigerator to let the medicine reach room temperature for 30 minutes before injecting your dose. Is there documentation of positive clinical response to therapy. 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. Remove the protective cap from one end of the transfer device and keeping the vial of swfi upright, insert the piercing pin vertically into the center of the stopper of the vial of swfi. Hypersensitivity administration of subcutaneous or intravenous benlysta may result in hypersensitivity reactions which can be severe, and fatal. Insert the entire needle into the pinched area of the skin at a slight degree angle using a. See full safety and boxed warning for more information. Benlysta belimumab for injection, for intravenous use. Benlysta prescribing information pdf benlysta mg solution for injection in prefilled syringe. These adverse effects can be found in the warning and precautions section of benlystas package insert. Safety of benlysta benlysta has been linked to numerous reports of serious adverse reactions.
Learn about cerezyme diagnosis, dosing, safety and support resources. For more information about using benlysta, see the package leaflet or contact your doctor or. The twostudies were similar in design except that bliss76 was a 76week study and bliss52 was a 52week study. Nulojix belatacept in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids is indicated for prophylaxis of organ rejection in adults receiving a kidney transplant. Highlights of prescribing information acute ischemic stroke. This product in formation was approved at the time this auspar was published. Benlysta injection for intravenous infusion package insert. Protect from light and do not shake or heat the medicine. Ilaris canakinumab for injection, for subcutaneous use ilaris canakinumab injection, for subcutaneous use initial u. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. This information only applies to gsk products available in australia.
In the event of a severe reaction, benlysta administration must be interrupted and. Information for the user benlysta 120 mg powder for concentrate for solution for infusion benlysta 400 mg powder for concentrate for solution for infusion belimumab this medicine is subject to additional monitoring. And patient does not have any of the following exclusion criteria. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis. Benlysta is a human igg1 lambda monoclonal antibody that inhibits the binding of soluble b lymphocyte stimulator protein blys to its b cell receptors.
Sections or subsections omitted from the full prescribing information are not listed. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Benlysta belimumab injectable medication precertification request aetna precertification notification 503 sunport lane, orlando, fl 32809 phone. 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 not. First approved lupus treatment option benlysta belimumab. Benlysta is not recommended for use in patients with severe active lupus nephritis or severe active central nervous system lupus. Highlights of prescribing information these highlights do not include all the information needed to use benlysta safely and effectively. An overview of benlysta and why it is authorised in the eu. Learn about benlysta belimumab, a treatment option that may be right for you. Pleuritispericarditis pleuritis history of pleuritic pain or rubbing heard by a physician or evidence of. Feb 03, 2020 what happens if i overdose benlysta, benlysta autoinjector. This will allow quick identification of new safety information.
This medication is given as an intravenous iv infusion, which is a slow injection into the vein. Both benlysta sc autoinjectors and prefilled syringes are stored in the refrigerator and the injections are to be taken once a week on the same day. Benlysta will not be used in combination with rituximab, other biologics, or iv cyclophosphamide, and benlysta is prescribed by a rheumatologist, and patient is 18 years of age or older, and physician attestation that the patients clinical status has not deteriorated, and. Insert the entire needle into the pinched area of the skin at. May, 2019 learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Highlights of prescribing information these highlights do not include all the information needed to use ilaris safely and effectively. Find patient medical information for benlysta subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Benlysta belimumab autoinjectors and prefilled syringes. See full prescribing information for rituxan hycela.
Apr 08, 2019 learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Benlysta belimumab for injection, for intravenous use and subcutaneous use. Mar 07, 2019 learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Benlysta 120 mg powder for concentrate for solution for infusion. Highlights of prescribing information these highlights do. Medical billing codes may not be used for benlysta injections for subcutaneous use. Benlysta is a monoclonal antibody that affects the actions of the bodys immune system.
Open the package containing the transfer device by peeling the paper label off the package. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour. Highlights of prescribing information these highlights. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Prior to initiating therapy, iswas the patient autoantibodypositive for autoantibodies relevant to sle e. Monoclonal antibodies are made to target and destroy only certain cells in the body. See important safety including boxed warnings for more information. Read all of this leaflet carefully before you start using this medicine because it contains important.
Product information for auspar benlysta belimumab glaxosmithkline pm 20100190832 final 31 october 2012. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Entyvio vedolizumab is indicated for adult patients with moderately to severely active ulcerative colitis uc or crohns disease cd who have had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids, or who have had an inadequate response with, lost response to, or were intolerant to an immunomodulator or a tumor necrosis factor tnf. Entyvio vedolizumab is indicated in adult patients with moderately to severely active uc who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor tnf blocker or immunomodulator. Use of benlysta is not recommended in these situations. This solution is readytouse and may be administered directly to the patient without further preparation. As a result, generic benlysta is not available and cannot be produced until these laws and rules are changed. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus.
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. Benlysta is for use in adults and children at least 5 years old. Remove the protective cap from the other end of the transfer. This emedtv resource takes a closer look at these factors and also offers information on how the lupus drug is given and what to expect during treatment. Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 1224 hours after the first infusion of rituxan in patients with nonhodgkins lymphoma nhl. Its important to remember that belimumab, benlystas active ingredient, is not a generic version of the drug. Benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active, autoantibodypositive, systemic lupus erythematosus sle. Benlysta belimumab injectable medication precertification. Some general considerations to keep in mind during treatment with benlysta include the following.
Use of nulojix for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. The safety and efficacy of benlysta have not been evaluated in patients with severe active lupus nephritis or. Benlysta is indicated in addition to standard therapyfor reducing disease activity in adult patients with active, autoantibodypositive, systemic lupus erythematosus sle. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. Benlysta helps decrease disease activity more than when the other medicines are used alone. Program an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion 2. Cerezyme is an enzyme replacement therapy ert, that treats pediatric and adult patients with gaucher disease type 1. Benlysta belimumab autoinjector and prefilled syringes are covered under the pharmacy benefit. However, hcpc code j0490 benlysta belimumab is addressed in the articles for. Patients should be instructed to seek immediate medical attention if they experience any of these symptoms.1022 781 845 89 940 973 7 1086 911 660 1216 230 370 945 1299 398 1312 188 1482 1256 1435 384 814 731 1344 449 306 466 838 610 276 1176