Boston, MA: Alexion Pharmaceuticals, Inc; 2019. Epub 2016 Jun 29. 2. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. 3. Accessed July 2020. N Engl J Med 2019; 381:2114. Boston, MA: Alexion Pharmaceuticals, Inc.: 7/2019. Revised: 4/2019 _____ 2 ; FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: MALIGNANCIES and RISK OF TERATOGENICITY 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Assessments Prior to Starting Each MAVENCLAD Treatment Course; … Amtrak’s ‘Coast Starlight’ heads north at Steilacoom, Wash., in June 2019. Soliris [package insert]. Parker CJ. Pittock SJ, Berthele A, Fujihara K, et al. Pittock SJ, Berthele A, Fujihara K, et al. References 1. 2016; 87(4):419. First trains return May 24; ticket inventory already on sale Email Newsletter Get the newest photos, videos, stories and more. Half-life of eculizumab is 11.25-17.25 days. Information for healthcare professionals about ULTOMIRIS® (ravulizumab-cwvz). Sanders DB, Wolfe GI, Benatar M, et al. Alexion OneSource™ provides gMG patient support. STN: BL 125046 Proper Name: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified Tradename: Gamunex-C Manufacturer: Grifols Therapeutics Inc, … See Full Prescribing Information, including Boxed Warning. With Soliris, A future with fewer relapses is possible. References 1. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. References 1. 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. N Engl J Med. 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, … Package Leaflet for a description). International consensus guidance for management of myasthenia gravis: Executive summary. Drug: Soliris 300 mg concentrate for solution for infusion. 3. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. 18. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Soliris [package insert]. 5.1 … 2007;25(11):1256-1264. ®Ultomiris [package insert]. 2019;381(7):614-625. Gaithersburg, MD: Viela Bio, Inc.: 6/2020. Nat Biotechnol. • Soliris [package insert]. Published online: April 11, 2015. 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]. Soliris [package insert]. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Sanders DB, Wolfe GI, Benatar M, et al. N Engl J Med. Safety and efficacy of eculizumab in anti-acetycholine receptor antibody-positive refractory generalized Myasthenia Gravis (REGAIN): a phase 3, randomised, double-blind, placebo-controlled, multicentre study. Soliris® [package insert]. 2.1 Recommended Dosage 2.2 Recommended Monitoring for Safety. Soliris [Package Insert]. Soliris while maintaining optimal therapeutic outcomes. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Pediatr Nephrol. Patients may have increased susceptibility to infections, especially with . SOLIRIS (eculizumab) Soliris FEP Clinical Rationale . Neurology. International consensus guidance for management of myasthenia gravis: Executive summary. Boston MA: Alexion Pharmaceuticals, Inc.; June 2019. Guidelines for the diagnosis and monitoring of paroxysmal nocturnal hemoglobinuria and related disorders by flow cytometry. The ‘Starlight’ and 11 other trains will be returned to … Epub 2016 Jun 29. Boston, MA; Alexion Pharmaceuticals, Inc; June 2019. Soliris [package insert]. 9/2020 Updated to include Uplizna™ and to change the policy name. Contact Supplier Request a quote . • Parker CJ. Volume 407, 15 December 2019, 116419 Long-term efficacy and safety of eculizumab in Japanese patients with generalized myasthenia gravis: A subgroup analysis of the REGAIN open-label extension study Author links open overlay panel Hiroyuki Murai a Akiyuki Uzawa b Yasushi Suzuki c Tomihiro Imai d Hirokazu Shiraishi e Hidekazu Suzuki f Meinoshin Okumura g Fanny O’Brien h Jing … FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGEAND ADMINISTRATION. Pediatr Nephrol. and encapsulated bacteria. 3 DOSAGEFORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGSAND PRECAUTIONS. 2. Blood. Under the Soliris REMS, prescribers must enroll in the program. 2. Revised: 12/2019 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: RISK OF ANAPHYLAXIS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dose 2.2 Instructions for Use 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Anaphylaxis and Hypersensitivity Reactions 5.2 Acute Respiratory Complications Associated with … SOLIRIS® (eculizumab) Prior Auth Criteria Proprietary Information. Resources for your patients on Soliris® (eculizumab). Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study. 2.3 Recommended ConcomitantTreatments 2.4 Dosage Modification for Adverse Reactions. July 1, 2019: Administrative update: Added new C code C9052 to Medical Necessity Guideline. 3. Verified Supplier. Under the Soliris REMS, prescribers must enroll in the program. 8, Block 2, Emerald Plaza Hiranandani Meadows, Thane W, Thane - 400610, Dist. 2. MN-280 SOLIRIS (eculizumab) ... Review Date: 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. 2016; 87(4):419. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. NULOJIX ® (belatacept) (in combination with basiliximab induction, mycophenolate mofetil [MMF], and corticosteroids) is indicated for prophylaxis of organ rejection in adults receiving a kidney transplant; Use NULOJIX only in patients who are Epstein-Barr virus (EBV) seropositive; Use of NULOJIX for prophylaxis of organ rejection in transplanted organs other than kidney has not been established Neurology. 2. Accessed July 2020. Soliris ® [package insert]. Trial of Satralizumab in Neuromyelitis Optica Spectrum Disorder. Howard JF Jr, Utsugisawa K, Benatar M, et al; for the REGAIN Study Group. 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. read more... Anmol Medical Stores. Uplizna™ [package insert]. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Pittock SJ, Berthele A, Fujihara K, et al. Boston, MA: Alexion Pharmaceuticals, Inc. 2. Lexi-Comp Clinical Application 2/2021 3.) Serious infections with Neisseria species (other than . Boston MA: Alexion Pharmaceuticals, Inc.; June 2019. Neisseria. Eculizumab in aquaporin-4-positive neuromyelitis optica spectrum disorder. Published online: April 11, 2015. 2. Enspryng Package Insert 2.) Lancet Neurol. Soliris [package insert]. Information, including weight-based dosing, about starting patients on ULTOMIRIS® (ravulizumab-cwvz). 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. UpToDate Clinical monograph: Neuromyelitis optica spectrum disorders reviewed 2/2021 4.) 2019;133(6):530-539. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Loirat C, Fakhouri F, Ariceta G, et al. Soliris [package insert]. Boston, MA: Alexion Pharmaceuticals, Inc. 2. 3. Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. International consensus guidance for management of myasthenia gravis: Executive summary. An international consensus approach to the management of atypical hemolytic uremic syndrome in children. Restricted Access – Do not disseminate or copy without approval. 2. 1/2021 Updated to include Enspryng™ and to change the policy name again. Lee JW, Sicre de Fontbrune F, Wong Lee Lee L, et al. Soliris. Alexion Pharmaceuticals, 2020. Soliris [package insert]. Pittock SJ, Berthele A, Fujihara K, et al. 1.) References 1. Boston, MA: Alexion Pharmaceuticals Inc; 2019. • Loirat C, Fakhouri F, Ariceta G, et al. 2/2021 Updated vaccination requirements for Soliris ®. Soliris was designated as an orphan medicinal product EU/3/13/1185 on 05 August 2013 in the following … Eculizumab in aquaporin-4–positive neuromyelitis optica spectrum disorder. 2016; 87(4):419. Thane, Maharashtra. Neurology. ©2020, Magellan Rx Management NDC: Soliris 300 mg/30 mL single-use vials for injection: 25682-0001-xx VII. Generic Name: eculizumab. See Full Prescribing Information, including Boxed Warning. Boston, MA: Alexion Pharmaceuticals, Inc. Rother RP, Rollins SA, Mojcik CF, Brodsky RA, Bell L. Discovery and development of the complement inhibitor eculizumab for the treatment of paroxysmal nocturnal hemoglobinuria. Sanders DB, Wolfe GI, Benatar M, et al. Type: Allopathic. Data on file; Global Drug Safety. Epub 2016 Jun 29. 7/2020 Implement a policy for both Ultomiris® & Soliris® References 1. Revised: 07/2019. Call +91-8037430465. 20. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Ultomiris [package insert]. [Package Insert]. Boston, MA: Alexion Pharmaceuticals, Inc.: 10/2019. 19. 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. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Soliris [Package Insert]. Boston MA: Alexion Pharmaceuticals, Inc.; June 2019. Other Systemic Infections Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active systemic infections. 2019;381(7):614-625. New Haven, CT: Alexion Pharmaceuticals, Inc.; June 2019. Package Leaflet and to the Risk Management Plan (RMP). 7/2020 Implement a policy for both Ultomiris ® & Soliris ® References 1. Thane Shop No. Yamamura T, Kleiter I, Fujihara K, et al.
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