In pnh patients, eculizumab profoundly inhibits haemolysis. Dilute soliris to a final concentration of 5 mgml by adding the appropriate amount. Please see important safety information and full prescribing information, including boxed warning, and medication guide. Restricted access do not disseminate or copy without approval.
Serious infections leading to hospitalization or death including. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria pnh to reduce hemolysis. Serious meningococcal infection soliris increases the risk of meningococcal infections 5. Eculizumab american journal of healthsystem pharmacy. J0 injection, eculizumab, soliris, 10 mg references soliris package insert. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Highlights of prescribing information these highlights do not include all the information needed to use empliciti safely and effectively. Soliris is a prescription medicine that is used to treat adults with a disease called generalized myasthenia gravis gmg who are antiacetylcholine receptor achr antibody positive. Use caution when administering soliris to patients with any systemic infection. Neisseria meningitidis, unless the risks of delaying soliris treatment outweigh the. Antiaqp4 antibodypositive neuromyelitis optica spectrum disorder nmosd soliris is a prescription medicine that. High risk for invasive meningococcal disease among patients receiving eculizumab soliris despite receipt of meningococcal vaccine. Soliris is a prescription medicine that is used to treat patients with a disease called paroxysmal nocturnal hemoglobinuria pnh. Soliris eculizumab is the first and only medication approved by the fda to treat adults with neuromyelitis optica spectrum disorder nmosd who are antiaquaporin4 aqp4 antibody positive.
Actemra tocilizumab injection, for intravenous or subcutaneous use initial u. Eculizumab contains human constant regions and murine complementaritydetermining regions grafted onto the human framework light and heavychain. Risk of serious infections see full prescribing information for complete boxed warning. Nucala mepolizumab for injection nucala mepolizumab. Highlights of prescribing information administration.
The pharmacokinetics of intradialytic administration of. Patients may have increased susceptibility to infections, especially with. Soliris eculizumab 1 full prescribing information warning. Soliris works by selectively inhibiting activation of specific proteins in the complement system c5a and c5b, which play a role in the pathophysiology of multiple rare diseases. Lifethreatening meningococcal infections have happened with eculizumab. Anaphylaxis anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, andor angioedema of the throat or tongue, has been reported to occur after administration of. Antibiotic prophylaxis should be administered until protective antibody titres are achieved using antibiotics able to eliminate neisseria spp. Soliris eculizumab 111 higher rate in the soliris group than the placebo group and at a rate of 5% or more among patients treated with 112 soliris. Soliris is a formulation of eculizumab which is a recombinant humanized monoclonal igg24. The effectiveness of soliris in ahus is based on the. Soliris 300 mg concentrate for solution for infusion.
Manage meningococcal disease risk in patients taking. Soliris increases the risk of meningococcal infections 5. Applying antibiotic prophylaxis for 2 weeks postvaccination only, as described in the package insert of. Eculizumab is not indicated for the treatment of patients with shiga toxin e. Soliris is a firstinclass terminal complement inhibitor discovered, developed, and commercialized by alexion. Vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate. Soliris is a prescription medicine that is used to treat adults and children with a disease called atypical hemolytic uremic syndrome ahus. Supplemental dosing of soliris is required in the setting of concomitant pepi plasmapheresis or plasma exchange, or fresh frozen plasma infusion type of. Soliris eculizumab injection, for intravenous use initial u. Use outside of these guidelines may result in nonpayment unless approved under an exception process. See full prescribing information for complete boxed warning.
Highlights of prescribing information these highlights. Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. Neisseria meningitidis, unless the risks of delaying soliris treatment outweigh the risks of developing. Patients should be provided with information from the package leaflet to. Actemra subcutaneous formulation is not intended for. Failure of first meningococcal vaccination in patients. Soliris is not for use in treating people with shiga toxin e. You will need to get a meningococcal vaccine at least 2 weeks before starting eculizumab unless your doctor. In people with pnh, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Meningococcal infection may become rapidly lifethreatening or fatal if not recognized. By providing my information above, i am giving alexion and companies working with alexion permission to contact me by mail, email, telephone call, andor text message for marketing purposes or otherwise provide me with information about alexions products, services, and programs or other topics of interest, conduct market research, or otherwise ask me about my experience with or thoughts about. Read all of this leaflet carefully before you start using.
There is insufficient evidence regarding safety and efficacy, therefore treatment of conditions other than ahus, pnh, myasthenia gravis, or nmosd are considered investigational. Additionally, aspergillus infections have occurred in immunocompromised and neutropenic patients. For sc administration, preferably using a 1ml polypropylene syringe fitted with a disposable 21 to 27gauge x 0. Page 2 of 21 full prescribing information 1 indications and usage 1. It inhibits the cleavage of c5 into c5a and c5b and hence inhibits deployment of the terminal complement system including the formation of mac.
This type of infection can become lifethreatening very fast and can be deadly if not treated early. Eculizumab, sold under the trade name soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria pnh, atypical hemolytic uremic syndrome ahus, and neuromyelitis optica. Preventing meningococcal disease in patients receiving soliris. Eculizumab is a longacting humanized monoclonal antibody targeted against complement c5. Indications the indications below including fdaapproved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the. Serious meningococcal infections see full prescribing information for complete boxed warning lifethreatening and fatal meningococcal infections have occurred in. Borowitz mj, craig fe, digiuseppe ja, illingworth aj, rosse w, sutherland dr, wittwer ct, richards sj. Soliris is indicated for the treatment of adult patients with generalized myasthenia gravis gmg who are antiacetylcholine receptor achr antibody positive. Lifethreatening and fatal meningococcal infections have occurred in patients treated with soliris. Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria. Please see indication and important safety information. Other systemic infections due to its mechanism of action, soliris therapy should be administered with caution to patients with active systemic infections. An international consensus approach to the management of atypical hemolytic uremic syndrome in children.
Serious meningococcal infections see full prescribing information for complete boxed warning life threatening and f atal meningococcal infections have occurred in patients treated with soliris and may become rapidly life threatening or. Shake the syringe immediately before use to form a homogeneous suspension. It may be used to help prevent melanoma from coming back after it and lymph nodes that contain cancer have been removed by surgery. Soliris eculizumab is covered under the medical benefit when used within the following guidelines. It is not known if soliris is safe and effective in children with nmosd. Eculizumab is a humanized monoclonal antibody approved by the us food and drug administration for the treatment of paroxysmal nocturnal hemoglobinuria and ahus in children and adults. It may be used when your melanoma has spread or cannot be removed by surgery advanced melanoma, or. Here, we report intradialytic administration of eculizumab and pharmacokinetic studies of an infant with endstage renal disease due to ahus. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry.