2. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. At the end of this period the product can be put back in the refrigerator. The safety of Soliris therapy in patients with aHUS was evaluated in four prospective, single-arm studies, three in adult and adolescent patients (Studies C08-002A/B, C08-003A/B, and C10-004), one in pediatric and adolescent patients (Study C10-003), and one retrospective study (Study C09-001r). Treat atypical-HUS with up to 8 weeks of freedom a. Member has been vaccinated against meningococcal infection at least 2 weeks prior to therapy initiation ii. Soliris 3 HMSA/CVS’s determination as to medical necessity in a given case, the physician may request that HMSA reconsider the application of the medical necessity criteria to the case at issue in light of any supporting documentation. - Keep this leaflet. Soliris 300 mg concentrate for solution for infusion . • Soliris [package insert]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). Soliris Therapeutic indication. SOLIRIS® dose adjustment to every 12 days may be necessary for some patients to maintain LDH reduction Concomitant medications allowed: – Steroids, immunosuppressant drugs, anti-clotting agents and hematinics1 SOLIRIS® (eculizumab) [package insert]. After dilution, the product should be used within 24 hours. Half-life of eculizumab is 11.25-17.25 days. Soliris [Package Insert]. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. Soliris ® (eculizumab). Pittock SJ, Berthele A, Fujihara K, et al. With Soliris, A future with fewer relapses is possible. References 1. Under the Soliris REMS, prescribers must enroll in the program. Soliris is the first and only approved treatment for patients with aHUS.7 By inhibiting the terminal complement cascade, it reduces TMA in patients with aHUS (as measured through hematologic markers of complement-mediated TMA, including platelet counts and … frequently than listed in the package insert, ... (aHUS): 2.1 Clinical documentation showing Shiga toxin-related HUS has been ruled out; AND ... 1.0 Approval is dependent on the prescriber being enrolled in the SOLIRIS REMS program. References 1. Pediatr Nephrol. Soliris [package insert]. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. • Loirat C, Fakhouri F, Ariceta G, et al. SOLIRIS ® (eculizumab) is a ... • Adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). References 1. c. ONE of the following: i. Soliris ® (eculizumab), a complement inhibitor, is the first and only medication approved by the FDA to treat adults with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Executives. New Haven, CT: Alexion Pharmaceuticals Inc; … Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. a The mean (SD) terminal elimination half-life and clearance of ravulizumab-cwvz in patients with PNH are 49.7 (8.9) days and 0.08 (0.022) L/day, respectively. 1. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Adults and children with Paroxysmal nocturnal haemoglobinuria (PNH) Mechanism of action. Cheshire, CT: Alexion Pharmaceuticals, Inc; December 2012. Soliris® (eculizumab) safety information. Although no specific agents are recommended, the eculizumab package insert notes that most patients in this situation received prophylactic antibiotics until at least 2 weeks after vaccination. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Alexion OneSource™ provides gMG patient support. H. REFERENCES 1. See Important Safety Information, including Boxed Warning, and full Prescribing Information. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Atypical hemolytic uremic syndrome (aHUS) is a life-threatening disease caused by an inherited or acquired defect in regulation of the complement system leading to platelet, leukocyte, and endothelial-cell activation and systemic thrombotic microangiopathy.1 Genetic mutations in the complement system are found in 40% to 60% of patients with aHUS.2 Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor ... Soliris [package insert]. References 1. 2. Soliris ® is a first-in-class terminal complement inhibitor discovered, developed, and commercialized by Aloxi. Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. hemolytic uremic syndrome (STEC-HUS). Soliris ® works by selectively inhibiting activation of specific proteins in the complement system (C5a and C5b), which play a role in the treatment of multiple rare diseases. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related … 1. • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 3/16/2007: Initial FDA approval for "the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis." You may need to read it again. Prior authorization is required to ensure the safe, clinically appropriate and cost-effective use of Soliris while maintaining optimal therapeutic outcomes. SOLIRIS can lower the ability of your immune system to fight infections. The effectiveness of Soliris in aHUS is based on the effects on … Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). Alexion Pharmaceuticals, Inc (NASDAQ:ALXN) FDA Approval of Soliris as a Treatment for Patients with aHUS Call Transcript September 26, 2011 10:00 AM ET. Atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy 3. Accessed July 2020. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome ... Soliris[package insert]. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), … Soliris [package insert]. Please see Important Safety Information, ... Soliris [package insert]. Soliris [package insert]. New Haven, CT: Alexion Pharmaceuticals, Inc.; October 2017. How Soliris® (eculizumab) inhibits complement activity. Leonard Bell - … 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. Boston, MA: Alexion Pharmaceuticals Inc; 2019 2. Soliris. References 1. hemolytic uremic syndrome (STEC-HUS). Figuring out how to manage atypical-HUS can be difficult to navigate. Boston, MA: Alexion Pharmaceuticals, Inc. 2. hemolytic uremic syndrome (STEC-HUS). Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. [Package Insert]. Member has been receiving eculizumab (Soliris) for the treatment of aHUS and is switching to ravulizumab . Eculizumab (Soliris) is FDA-approved for the treatment of atypical hemolytic uremic syndrome (aHUS) in adult and pediatric patients to inhibit complement-mediated thrombotic microangiopathy ... Soliris [package insert]. Accessed July 2020. November 12, 2019: Added Ultomiris to the coverage criteria for aHUS based on updated package labeling. 19. For adult and pediatric patients with aHUS and adult patients with gMG, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2).Table 2: Supplemental Dose of Soliris after PE/PIType of Plasma InterventionMost Recent Soliris DoseSupplemental Soliris Dose With Each Plasma … Soliris ® [package insert]. 1/2021 Updated to include Enspryng™ and to change the policy name again. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. aHUS, gMG 90 billable units Days 1, 8, 15, & 22; then 120 billable units Day 29 120 billable units every 14 days III. SOLIRIS was the first therapy approved for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Store in the original package in order to protect from light. Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. Soliris [Package Insert]. 2/2021 Updated vaccination requirements for Soliris ®. Eculizumab . 9/2020 Updated to include Uplizna™ and to change the policy name. Alexion Pharmaceuticals; 2009. Package leaflet: Information for the user . August 13, 2019: Added criteria for Soliris for the expanded indication of treatment of NMOSD in adult patients who are anti-aquaporin-4 antibody positive. Published online: April 11, 2015. • Parker CJ. Eculizumab, the active ingredient in Soliris, is a terminal complement inhibitor that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9. Use of Soliris in aHUS Prior to Supportive Care with Either Plasma Exchange or Plasma Infusion - Now Specifically Included in Package Insert with Additional Two Prospective Trials CHESHIRE, Conn.--(BUSINESS WIRE)-- Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) … 20. 1 SOLIRIS is approved for the treatment of patients with aHUS in more than 40 countries, including the United States, European Union, and Japan. aHUS. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com. SOLIRIS is a medicine that affects your immune system. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). SOLIRIS and aHUS. Initial Approval Criteria Soliris must be requested by one of the following specialists: PNH – Hematologist; OR Atypical hemolytic uremic syndrome – Hematologist or Nephrologist; AND 2. See Important Safety Information, including Boxed Warning, and full Prescribing Information.