This product in formation was approved at the time this auspar was published. Benlysta belimumab for injection, for intravenous use. Program an infusion pump to deliver the appropriate volume as a bolus at the initiation of the infusion 2. Highlights of prescribing information these highlights. Sections or subsections omitted from the full prescribing information are not listed. Is there documentation of positive clinical response to therapy. Benlysta should not be infused concomitantly in the same intravenous line with other agents. Open the package containing the transfer device by peeling the paper label off the package.
Highlights of prescribing information an initial dose of 600. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Benlysta belimumab is the first and only approved treatment designed for lupus sle or systemic lupus erythematosus. Ilaris canakinumab for injection, for subcutaneous use ilaris canakinumab injection, for subcutaneous use initial u.
Benlysta belimumab side effects, images, uses, dosage. 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. The safety and efficacy of benlysta have not been evaluated in patients with severe active lupus nephritis or. Remove the protective cap from the other end of the transfer. Nonerosive arthritis involving 2 or more peripheral joints 6. If you are a new user to the site, please click the register now button to begin the registration process. Pleuritispericarditis pleuritis history of pleuritic pain or rubbing heard by a physician or evidence of. Length of authorization coverage will be provided for 12 months and may be renewed. These highlights do not include all the information needed to use benlysta safely and effectively. The twostudies were similar in design except that bliss76 was a 76week study and bliss52 was a 52week study.
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. Use of nulojix for prophylaxis of organ rejection in transplanted organs other than kidney has not been established. Jun 14, 2019 benlysta prescribing information pdf benlysta mg solution for injection in prefilled syringe. Patients should be instructed to seek immediate medical attention if they experience any of these symptoms. Administer aggressive intravenous hydration and antihyperuricemic therapy in patients at high risk for tls. 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. Find patient medical information for benlysta subcutaneous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Highlights of prescribing information adequately rehydrate. Full prescribing information 1 indications and usage dupixent is indicated for the following diseases.
This will allow quick identification of new safety information. First approved lupus treatment option benlysta belimumab. Benlysta is for use in adults and children at least 5 years old. However, hcpc code j0490 benlysta belimumab is addressed in the articles for. In the event of a severe reaction, benlysta administration must be interrupted and. Jan 22, 2020 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. Monitor patients during and for an appropriate period of time after administration of benlysta. May, 2019 learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Caution should be exercised if benlysta is coadministered with other b cell targeted therapy or cyclophosphamide. Take the package out of the refrigerator to let the medicine reach room temperature for 30 minutes before injecting your dose. Highlights of prescribing information these highlights do.
Benlysta belimumab vials are covered under the medical benefit. Benlysta helps decrease disease activity more than when the other medicines are used alone. Its important to remember that belimumab, benlystas active ingredient, is not a generic version of the drug. Vision impaired people having problems accessing certain pages of a pdf file may call 301 7963634 for assistance. For more information about using benlysta, see the package leaflet or contact your doctor or.
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. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Safety of benlysta benlysta has been linked to numerous reports of serious adverse reactions. This medication is given as an intravenous iv infusion, which is a slow injection into the vein. The efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Learn about cerezyme diagnosis, dosing, safety and support resources. 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 injection, for subcutaneous use initial u. These highlights do not include all the information needed to use. The information was added in the codes section as the following. Added anaphylaxis with prior benlysta administration as. Watch the rituxan hycela rituximabhyaluronidase human dosing and administration video for hcps. Trademarks are owned by or licensed to the gsk group of companies.
Rituxan hycela rituximab and hyaluronidase human injection, for subcutaneous use initial u. Highlights of prescribing information these highlights do not include all the information needed to use ilaris safely and effectively. Highlights of prescribing information an initial dose. Benlysta 120 mg powder for concentrate for solution for infusion. It is usually given every two weeks for the first three doses and then once a month. Benlysta belimumab autoinjector and prefilled syringes are covered under the pharmacy benefit. Use of benlysta is not recommended in these situations.
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 prescribing information pdf benlysta mg solution for injection in prefilled syringe. Highlights of prescribing information these highlights do not include all the information needed to use benlysta safely and effectively. See important safety including boxed warnings for more information. Feb 03, 2020 what happens if i overdose benlysta, benlysta autoinjector. Highlights of prescribing information these highlights do not include all the information needed to use rituxan hycela safely and effectively. Benlysta is a monoclonal antibody that affects the actions of the bodys immune system. Prior to initiating therapy, iswas the patient autoantibodypositive for autoantibodies relevant to sle e. What should i avoid while using belimumab benlysta, benlysta autoinjector. Restricted access do not disseminate or copy without approval. Learn about benlysta belimumab, a treatment option that may be right for you. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus.
These adverse effects can be found in the warning and precautions section of benlystas package insert. This information only applies to gsk products available in australia. Insert the entire needle into the pinched area of the skin at. 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.
Does the patient have either of these active conditions. Product information for auspar benlysta belimumab glaxosmithkline pm 20100190832 final 31 october 2012. If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot. As a result, generic benlysta is not available and cannot be produced until these laws and rules are changed. Benlysta is indicated in addition to standard therapyfor reducing disease activity in adult patients with active, autoantibodypositive, systemic lupus erythematosus sle. Local coverage determinations lcds do not exist at this time. Tell your doctor at once if you develop signs of infection. 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. 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. Benlysta iv belimumab prior auth criteria proprietary information. 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. Read all of this leaflet carefully before you start using this medicine because it contains important. Benlysta belimumab for injection, for intravenous use and subcutaneous use. Benlysta is a human igg1 lambda monoclonal antibody that inhibits the binding of soluble b lymphocyte stimulator protein blys to its b cell receptors.
Mar 04, 2020 benlysta is used together with other lupus medicines to treat active systemic lupus erythematosus sle. Highlights of prescribing information these highlights do not. Persons with disabilities having problems accessing the pdf files below may call 301 7963634 for assistance. Insert the entire needle into the pinched area of the skin at a slight degree angle using a. 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. Some general considerations to keep in mind during treatment with benlysta include the following. Seek emergency medical attention or call the poison help line at 18002221222. Benlysta is not recommended for use in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta sq belimumab prior auth criteria proprietary information. Monoclonal antibodies are made to target and destroy only certain cells in the body. Medicare does not have a national coverage determination ncd for benlysta belimumab. See full prescribing information for rituxan hycela. This solution is readytouse and may be administered directly to the patient without further preparation. 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. 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 should be administered by healthcare providers prepared to manage anaphylaxis. 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 acute ischemic stroke. This may help to protect healthy cells from damage. Protect from light and do not shake or heat the medicine. May 17, 2019 provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the us food and drug administration. Use nulojix only in patients who are epsteinbarr virus ebv seropositive. Medical billing codes may not be used for benlysta injections for subcutaneous use. Benlysta belimumab injectable medication precertification request aetna precertification notification 503 sunport lane, orlando, fl 32809 phone. An overview of benlysta and why it is authorised in the eu.
This site is intended for us healthcare professionals only. The package leaflet should be available to the patient. See full safety and boxed warning for more information. These have been observed with benlysta in clinical trials. 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. Benlysta belimumab injectable medication precertification. Avoid being near people who are sick or have infections.
Cerezyme is an enzyme replacement therapy ert, that treats pediatric and adult patients with gaucher disease type 1. In trial 2 at 76 weeks, benlysta 10mgkg did not have a significant sri compared to placebo. Sle is an inflammatory autoimmune disease, which means that the bodys immune system attacks its own tissues and causes inflammation. Belimumab benlysta is a synthetic manmade injectable antibody that reduces the activity of immune cells called bcells in patients with systemic lupus erythematosus sle. Highlights of prescribing information these highlights do not include all the information needed to use dupixent safely and effectively. 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. Hypersensitivity administration of subcutaneous or intravenous benlysta may result in hypersensitivity reactions which can be severe, and fatal. Many different factors affect your dose of benlysta. Benlysta injection for intravenous infusion package insert.
Talk to your doctor about benlysta for more information. Benlysta belimumab for injection, for intravenous use only initial u. Benlysta belimumab autoinjectors and prefilled syringes. Dosing limits max units per dose and over time medical benefit. Use benlysta exactly as your healthcare provider tells you to. 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. Is benlysta being prescribed by or in consultation with a rheumatologist. Read the instructions for use that come with benlysta to learn the proper way inject yourself at home. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour.
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