9/2020 Updated to include Uplizna™ and to change the policy name. Review Date: 09/18/2019, 12/20/2019, 1/22/20, 12/2020 Revision Date: 09/18/2019, 1/22/20, 12/2020 Purpose: To support safe, effective and appropriate use of Soliris (eculizumab). You can help by reporting any side effects you may get. Serogroup B meningococci (MenB) are the most frequently encountered cause for meningococcal infections in Europe. Under the Soliris REMS, prescribers must enroll in the program. Take care not to touch the exposed end of the device. [Package Insert]. Information, including weight-based dosing, about starting patients on ULTOMIRIS® (ravulizumab-cwvz). In 2010, ACIP voted to remove the precaution for persons with a history of GBS from the ACIP recommendations, although it continues to be listed as a precaution in the package insert (16,67). Atypical hemolytic uremic syndrome (aHUS) is a disorder belonging to the category of diseases known as thrombotic microangiopathies (TMAs; Figure 1).The pathologic lesion that defines all of the TMAs includes thickening of arterioles and capillary walls, prominent endothelial swelling and detachment, and subendothelial accumulation of proteins and cell debris. Epub 2016 Jun 29. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. 1310 G Street, N.W. 3.lace P vial of CINRYZE on a flat surface. Soliris® [package insert]. Pediatr Nephrol. Sanders DB, Wolfe GI, Benatar M, et al. 2. Soliris. Revised 11/2020 : MEDICATION GUIDE Soliris ® (so-leer-is) (eculizumab) injection, for intravenous use: What is the most important information I should know about Soliris? • Parker CJ. Soliris ® [package insert]. Soliris® (eculizumab) (Intravenous) Document Number: IC-0114 Last Review Date: 09/01/2020 Date of Origin: 06/21/2011 Dates Reviewed: 09/2011, 12/2011, 03/2012, 06/2012, 09/2012, 12/2012, 03/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 06/2015, 09/2015, 12/2015, 03/2016, 06/2016, 09/2016, 12/2016, 03/2017, 06/2017, 09/2017, 10/2017, 03/2018, 06/2018, 10/2018, 02/2019, 08/2019, 8/2020, … 2. Soliris. Evaluations of VSD data through 2014 and VAERS data through 2016 have since been conducted, identifying no new GBS-related concerns (CDC, unpublished data, 2020). New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. References 1. Serious infections with Neisseria species (other than . Soliris [package insert]. Gaithersburg, MD: Viela Bio, Inc.: 6/2020. A Product Information document (PI) provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine, some non-prescription medicines and some biologicals. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. See the end of section 4 for how to report side effects. Abstract. - Keep this leaflet. Revised: 10/2020 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: SERIOUS MENINGOCOCCAL INFECTIONS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Vaccination and Prophylaxis 2.2 Recommended Weight-Based Dosage Regimen - PNH 2.3 Recommended Weight-Based Dosage Regimen - aHUS 2.4 Dosing Considerations 2.5 Preparation … This will allow quick identification of new safety information. MN-280 SOLIRIS (eculizumab) ... 01/28/2019, 10/23/2019, 12/07/2020 Available Through: X Medical Benefit Pharmacy Benefit Available Dosage Forms: Dosage Forms And Strengths Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial Usual Dose: General Dosing Information For intravenous infusion only. 2.emo R ve the plastic package and discard it (Figure 2). Boston, MA: Alexion Pharmaceuticals, Inc.: 7/2019. Soliris is a medicine that affects your immune system. Accessed October 2020. Soliris increases your chance of getting serious and life-threatening meningococcal … 1. Package leaflet: Information for the user. References 1. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. 6.5 Nature and contents of container. Use outside of these guidelines … Soliris can lower the ability of your immune system to fight infections. 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. and encapsulated bacteria. SOLIRIS® (eculizumab) is a first-in-class complement inhibitor that targets the underlying cause of disease.1 SOLIRISis approved for the treatment of four devastating, debilitating, rare, complement-mediated disorders: 7/2020 Implement a policy for both Ultomiris® & Soliris® References 1. Package leaflet: Information for the user . Boston MA: Alexion Pharmaceuticals, Inc.; June 2019. Boston, MA; Alexion Pharmaceuticals, Inc; October 2020. - If you have any further questions, ask your doctor, pharmacist or nurse. SOLIRIS (eculizumab) Soliris FEP Clinical Rationale . Resources for your patients on Soliris® (eculizumab). 1. Soliris is a complement inhibitor indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. International consensus guidance for management of myasthenia gravis: Executive summary. Loirat C, Fakhouri F, Ariceta G, et al. Figure 2. 2016; 87(4):419. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. Only your doctor can recommend a course of treatment after checking your health condition. All PIs will be changed to the new format by the end of 2020. Alexion OneSource™ provides gMG patient support. Efficacy of the protein-based MenB-vaccine Bexsero in aHUS has not been … • Soliris [package insert]. Published online: April 11, 2015. Patients may have increased susceptibility to infections, especially with . 3. 3/16/2007: Initial FDA approval for "the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis." Soliris (eculizumab), developed by Alexion Pharmaceuticals, is approved by the U.S. Food and Drug Administration (FDA) and the European Commission to treat certain adults with generalized myasthenia gravis.It is given as an intravenous (IV) infusion once a week for one month, followed by a fifth dose one week later and then ongoing infusions once every two weeks. See Important Safety Information, including Boxed Warning, and full Prescribing Information. View Product Information documents . See Full Prescribing Information, including Boxed Warning. Accessed July 2020. 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. Background: The C5 complement inhibitor eculizumab is first-line treatment in atypical hemolytic uremic syndrome (aHUS) going along with a highly increased risk of meningococcal infections. Package Leaflet for a description). Published online: April 11, 2015. ®Ultomiris [package insert]. Soliris is not indicated for the treatment of patients with Shiga toxin E. Coli related hemolytic uremic syndrome (STEC-HUS) Speak with your doctor about how Soliris can help in the treatment of aHUS. You may need to read it again. Soliris vials in the original package may be removed from refrigerated storage for only one single period of up to 3 days. 2. frequently than listed in the package insert, or generally accepted by peers and the reason for additional services is not justified by submitted documentation. 1/2021 Updated to include Enspryng™ and to change the policy name again. Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url; 11/20/2020: SUPPL-434: Labeling-Package Insert Eculizumab (Soliris) package insert; Eculizumab (Soliris) patient drug information (Chemocare) Eculizumab (Soliris) patient drug information (UpToDate) History of changes in FDA indication . Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. See Important Safety Information, including Boxed Warning, and full Prescribing Information. RELATED: The top 20 drugs in 2020--worldwide sales – 8. Ultomiris 300 mg/30 mL concentrate for solution for infusion. 9/2020 Updated to include Uplizna™ and to change the policy name. Neisseria. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. • Loirat C, Fakhouri F, Ariceta G, et al. ravulizumab This medicine is subject to additional monitoring. Boston, MA: Alexion Pharmaceuticals, Inc.: 10/2019. Parker CJ. At the end of this period the product can be put back in the refrigerator. A decision on the validity of the new Soliris patents is expected in Q3 2020, as the U.S. patent office may require a full year for its assessment, SVB Leerink analyst Geoffrey Porges said. Eculizumab . Paroxysmal Nocturnal Hemoglobinuria For patients 18 years of age and older: • 600 mg weekly … 2/2021 Updated vaccination requirements for Soliris ®. Get traffic statistics, SEO keyword opportunities, audience insights, and competitive analytics for Pnhleeds. What marketing strategies does Pnhleeds use? For storage conditions after dilution of the medicinal product, see section 6.3. 5.85.11 Section: Prescription Drugs Effective Date: October 1, 2020 Subsection: Hematological Agents Original Policy Date: September 8, 2011 Subject: Soliris Page: 1 of 7 Last Review Date: September 1, 2020 Soliris Description Soliris (eculizumab) Background Soliris is a complement inhibitor indicated for the treatment of patients with paroxysmal Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Uplizna™ [package insert]. Scope: Medicaid, Commercial, Medicare-Medicaid Plan (MMP) Policy Statement: Soliris (eculizumab) is covered under the Medical Benefit when used within the following guidelines. Soliris 300 mg concentrate for solution for infusion . 3. 2. REMICADE ® (infliximab) can cause serious side effects such as lowering your ability to fight infections. With Soliris, A future with fewer relapses is possible. Ultomiris [package insert]. Neurology. 2. Pediatr Nephrol. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. Soliris while maintaining optimal therapeutic outcomes. Soliris [package insert]. Analysts were expecting Alexion to prevail over Amgen in the United States, where Soliris raked in about 51% of its total sales in the last quarter. Other Systemic Infections Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections.