Retreatment of pagets disease after a single treatment with reclast in pagets disease an extended remission period is observed. The infusion rate may be slowed or interrupted if the patient develops an infusion reaction. The reconstituted vial contains 20 mgml dalbavancin as a clear, colorless to yellow solution. Belimumab benlysta is a biologic reference with prescribing information, dosage. This site is intended for canadian healthcare professionals only and is not intended as a means for reporting an adverse event side effect or complaint for any glaxosmithkline product. Benlysta treatment should be initiated and supervised by a qualified physician experienced in the. Sandostatin lar depot is available in singleuse kits for injectable suspension containing a 6ml vial of 10 mg, 20 mg, or 30 mg strength, a syringe containing 2 ml of diluent, one vial adapter, and one sterile 1. 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. Benlysta is a prescription medication used to treat patients with active systemic lupus erythematosus sle or lupus who are receiving other lupus medicines.
Benlysta should not be infused concomitantly in the same intravenous line with other agents. Serious and sometimes fatal infections have been reported in patients receiving. 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. Belimumab is given in a health care providers office, a hospital, or an infusion center by an administration of the medication directly into a vein infusion. Benlysta iv belimumab prior auth criteria proprietary information. Benlysta is a blymphocyte stimulator blysspecific inhibitor indicated for the treatment of adult patients with active, autoantibodypositive, systemic lupus erythematosus who are receiving standard therapy. Caution should be exercised if benlysta is coadministered with other b cell targeted therapy or cyclophosphamide.
See full prescribing information including boxed warning on serious infections. Actemra subcutaneous formulation is not intended for. These adverse effects can be found in the warning and precautions section of benlystas package insert. Aseptically transfer the required dose of reconstituted dalbavancin solution. Efficacy and safety of the subcutaneous belimumab in systemic lupus erythematosus. It is supplied in clear glass vials, each containing 375 mg. Cimzia certolizumab pegol an fdaapproved biologic treatment. Highlights of prescribing information hypocalcemia may worsen. May, 2019 belimumab package insert pdf admin may, 2019 leave a comment 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. Atgam lymphocyte immune globulin, antithymocyte globulin equine sterile solution this product information is intended only for residents of the united states. You can find an az list of our prescription medicines available in the us below. Restricted access do not disseminate or copy without approval.
Highlights of prescribing information these highlights. Nurses are available by phone anytime to talk you through your injections. Benlysta has not been studied in combination with other b cell targeted therapy or intravenous cyclophosphamide. Refer to the dexamethasone prescribing information for other information on that product. Safety of benlysta benlysta has been linked to numerous reports of serious adverse reactions. First approved lupus treatment option benlysta belimumab.
Atgam lymphocyte immune globulin, antithymocyte globulin. The infusion time must not be less than 15 minutes given over a constant infusion rate. Highlightsof prescribing information kyprolis safely and. Jan 17, 2020 benlysta for intravenous use is provided as a lyophilized powder in a single.
With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Use of a 21 to 25gauge needle is recommended when piercing the vial stopper for reconstitution and dilution. August 12, 2019 page 3 of 4 applicable procedure codes j0490 injection, belimumab, 10 mg. Twice weekly 2056mgm2 regimen by 30minute infusion kyprolis is administered intravenously as a 30minute infusion on two consecutive days, each week for threeweeks followed by a 12day rest period as shown in table2. Highlights of prescribing information for intravenous. Reconstituted vials may be stored either refrigerated at 2 to 8 c 36 to 46 f, or at controlled room temperature 20 to 25 c 68 to 77 f. This leaflet is part iii of a threepart product monograph. The package leaflet should be available to the patient. Use of benlysta is not recommended in these situations. Approximately half the cases were lymphomas, including hodgkins and nonhodgkins lymphoma. Use nulojix only in patients who are epsteinbarr virus ebv seropositive. Belimumab can be given as an infusion or injection. Gskpro ca product information for healthcare professionals. Benlysta belimumab for injection, for intravenous use only.
Cidofovir is a white crystalline powder with an aqueous solubility of. Benlysta belimumab for injection, for intravenous use. The other cases represented a variety of malignancies, including rare malignancies. Learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Policy document for benlysta medical the overall objective of this policy is to support the appropriate and cost effective use of the medication, specific to use of lower cost site of care and overall clinically appropriate use. Belimumab can also be given as an injection under the skin subcutaneous injection. Benlysta for intravenous use is available as 120 mg in a 5ml. Benlysta should be administered by healthcare providers prepared to manage anaphylaxis see warnings and precautions 5. Unfortunately, we cannot provide comprehensive information about our medicines on this website, in compliance with. Our pharmaceuticals business discovers, develops and makes medicines to treat a broad range of the worlds most common acute and chronic diseases. Belimumab benlysta is a biologic reference with prescribing information, dosage, medication administration, and possible side effects. Lift the package cover away from the vial adapter and discard the cover. Benlysta has not been studied in combination with other.
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tnf blockers, of which simponi aria. These have been observed with benlysta in clinical trials. Build and strengthen your selfinjection skills by phone with our trained nurses. Learn more about benlysta belimumab for subcutaneous use. Member information required provider information required member name. Highlights of prescribing information hypocalcemia. The diluted solution of benlysta should be administered by intravenous infusion over a period of 1 hour. Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Highlights of prescribing information these highlights do not. To report an adverse event or product complaint, please call 18003877374. Insert the syringe needle into the vial through the dosage in adult kidney transplant recipients nulojix should be administered in combination with basiliximab induction, mycophenolate mofetil mmf, and corticosteroids. Use of nulojix for prophylaxis of organ rejection in transplanted organs other than kidney has not been established.
Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Patients should be monitored for new or worsening neurological, cognitive, or behavioral signs and symptoms. Highlights of prescribing information hypocalcemia may. Nulojix is contraindicated in patients who are ebv seronegative or with unknown serostatus because the risk of ptld is particularly increased in patients who are ebv seronegative. Reconstitute, dilute, and administer as an intravenous infusion over a period of 1 hour. Delayedtype, nonacute hypersensitivity reactions have also been observed and included symptoms such. Benlysta has not been studied in combination with other biologics or intravenous cyclophosphamide. Subcutaneous dosing of benlysta is only approved for adult patients. Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. Risk of serious infections see full prescribing information for complete boxed warning. Jun 14, 2019 learn about benlysta belimumab, an fdaapproved prescription infusion or selfinjectable lupus medication to help treat your request your free info kit. Serious infections leading to hospitalization or death including. Eular recommendations for the management of systemic. Benlysta belimumab injection, for subcutaneous use initial u.
The recommended intravenous dosage regimen is 10 mgkg at 2. Highlights of prescribing information these highlights do. For sc administration, preferably using a 1ml polypropylene syringe fitted with a disposable 21 to 27gauge x 0. Benlysta 3 cvs caremark reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. If you are an adult, benlysta can be taken by injection. Apr 08, 2019 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 efficacy of benlysta has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Benlysta 120 mg powder for concentrate for solution for infusion. Intravenous dosing of benlysta is approved for adults and children aged 5 years and older. Higher than recommended doses or more frequent dosing of. Etiologies included infection, cardiovascular disease and suicide. Actemra subcutaneous formulation is not intended for intravenous. Read the medication guide and instructions for use provided by your pharmacist before you start using belimumab and each time you get a refill. Hypersensitivity administration of subcutaneous or intravenous benlysta may result in hypersensitivity reactions which can. Nucala mepolizumab for injection nucala mepolizumab. Patients with a history of multiple drug allergies or significant. This document provides specific information to each section of the overall policy. Benlysta belimumab is indicated for the treatment of patients aged 5 years and older with active, autoantibodypositive, systemic lupus erythematosus sle.
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