References 1. 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. Pediatr Nephrol. 2. Leonard Bell - … See Important Safety Information, including Boxed Warning, and full Prescribing Information. Generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor ... Soliris [package insert]. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. 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) … 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. • Soliris [package insert]. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. References 1. 2. References 1. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. 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 [package insert]. Published online: April 11, 2015. • Parker CJ. 1 SOLIRIS is approved for the treatment of patients with aHUS in more than 40 countries, including the United States, European Union, and Japan. Boston, MA: Alexion Pharmaceuticals Inc; 2019 2. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Cheshire, CT: Alexion Pharmaceuticals, Inc; December 2012. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris ® (eculizumab). aHUS, gMG 90 billable units Days 1, 8, 15, & 22; then 120 billable units Day 29 120 billable units every 14 days III. 2/2021 Updated vaccination requirements for Soliris ®. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Soliris while maintaining optimal therapeutic outcomes. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 1. 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. Soliris [Package Insert]. Soliris 300 mg concentrate for solution for infusion . 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. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 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. 3/16/2007: Initial FDA approval for "the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis." Soliris [package insert]. Member has been receiving eculizumab (Soliris) for the treatment of aHUS and is switching to ravulizumab . Soliris Therapeutic indication. New Haven, CT: Alexion Pharmaceuticals Inc; … Soliris [package insert]. 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. Pittock SJ, Berthele A, Fujihara K, et al. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. hemolytic uremic syndrome (STEC-HUS). 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). New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. • Loirat C, Fakhouri F, Ariceta G, et al. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 … Under the Soliris REMS, prescribers must enroll in the program. After dilution, the product should be used within 24 hours. How Soliris® (eculizumab) inhibits complement activity. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome ... Soliris[package insert]. SOLIRIS and aHUS. 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 … SOLIRIS ® (eculizumab) is a ... • Adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). - Keep this leaflet. Adults and children with Paroxysmal nocturnal haemoglobinuria (PNH) Mechanism of action. 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. Alexion OneSource™ provides gMG patient support. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), … Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication. 20. Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. Executives. 1. 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. Soliris ® [package insert]. Figuring out how to manage atypical-HUS can be difficult to navigate. Prior authorization is required to ensure the safe, clinically appropriate and cost-effective use of Soliris while maintaining optimal therapeutic outcomes. 2. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). Alexion Pharmaceuticals; 2009. 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]. Initial Approval Criteria Soliris must be requested by one of the following specialists: PNH – Hematologist; OR Atypical hemolytic uremic syndrome – Hematologist or Nephrologist; AND Half-life of eculizumab is 11.25-17.25 days. November 12, 2019: Added Ultomiris to the coverage criteria for aHUS based on updated package labeling. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related … SOLIRIS can lower the ability of your immune system to fight infections. Soliris. Please see Important Safety Information, ... Soliris [package insert]. SOLIRIS is a medicine that affects your immune system. Member has been vaccinated against meningococcal infection at least 2 weeks prior to therapy initiation ii. H. REFERENCES 1. Accessed July 2020. Boston, MA: Alexion Pharmaceuticals, Inc. 2. You may need to read it again. Eculizumab . c. ONE of the following: i. 1/2021 Updated to include Enspryng™ and to change the policy name again. References 1. Treat atypical-HUS with up to 8 weeks of freedom a. Store in the original package in order to protect from light. 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]. 19. Soliris® (eculizumab) safety information. References 1. 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. • SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Package leaflet: Information for the user . hemolytic uremic syndrome (STEC-HUS). Accessed July 2020. SOLIRIS was the first therapy approved for the treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. New Haven, CT: Alexion Pharmaceuticals, Inc.; October 2017. [Package Insert]. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. With Soliris, A future with fewer relapses is possible. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. 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. Soliris ® is a first-in-class terminal complement inhibitor discovered, developed, and commercialized by Aloxi. hemolytic uremic syndrome (STEC-HUS). aHUS. 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. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 9/2020 Updated to include Uplizna™ and to change the policy name. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy 3. 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 The effectiveness of Soliris in aHUS is based on the effects on … At the end of this period the product can be put back in the refrigerator. Soliris [Package Insert].
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