–Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS®. For more information, ask your doctor or pharmacist. ", Clinical Data from the AEGIS Extension Study, Twenty-seven Japanese patients entered the extension of the AEGIS study. These are not all the possible side effects of SOLIRIS. Call your doctor for medical advice about side effects. >> Alexion is evaluating other potential indications for Soliris as well as other formulations of eculizumab for additional clinical indications, and is pursuing development of other antibody product candidates in early stages of development. 2002;100 (12):3897-3902. The most common side effects in people with NMOSD treated with SOLIRIS include: common cold (upper respiratory infection) pain or swelling of your nose or throat (nasopharyngitis) Patients received 600 mg of Soliris every 7 days (+/- 2 days) for 4 weeks; 900 mg one week later; then 900 mg every 14 days (+/- 2 days) for a total of 38 weeks of therapy. Prior to these approvals, there were no therapies specifically available for the treatment of PNH. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. /Type /Catalog The resulting scar tissue can lead to long-term breathing problems. Lancet. trailer Blood. Headache 8. /ID [ (sobbkvoqhqosctuv) The type of pneumonia often associated with COVID-19 can cause long-standing damage to the tiny air sacs (alveoli) in the lungs. Fever 7. 6. No thrombotic events or meningococcal infections were reported during Soliris treatment. /Size 29 /Root 15 0 R Low Energy 11. (6) PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS). 0000015930 00000 n PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com. Soliris has been approved by the U.S. Food and Drug Administration (March 2007), the European Commission (June 2007), Health Canada (January 2009) and Australia's Therapeutic Goods Administration (February 2009) as the first treatment for all patients with PNH, an ultra-rare, debilitating and life-threatening blood disorder defined by chronic hemolysis, or the destruction of red blood cells. We use cookies to give you the best online experience. The following Soliris side effects are common (occurring in greater than 30%) for patients taking Soliris: High blood pressure startxref /Dests << 1996: 348:573-577. 0000051646 00000 n The most common side effect with Soliris (seen in more than 1 patient in 10) is headache. Soliris is Alexion's first marketed product. Iwanga M, Furukawa K, Amenomori T, et al. >> "We anticipate that regulatory authorities in Japan may make a decision on our application for marketing authorization next year, and we are preparing to make Soliris available to physicians and patients in Japan in late 2010. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Nausea 13. xref The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. /Fit ] By using our website, you agree to our use of cookies in accordance with our, Long-Term Soliris(R) Treatment Resulted in Sustained Reduction in Hemolysis and Improved Kidney Function in Japanese Patients with PNH. Clinical course and flow cytometric analysis of paroxysmal nocturnal hemoglobinuria in the United States and Japan. 16 0 obj 2001;115:1015-1022. This website is intended only for residents of the United States. Drug companies should be thinking of the long-term effect on people who can’t even consent. 0000001300 00000 n Prior to beginning Soliris therapy, all patients and their prescribing physicians are encouraged to enroll in the PNH Registry, which is part of a special risk-management program that involves initial and continuing education and long-term monitoring for detection of new safety findings. (2). /PageMode /UseNone (7,8,9) In patients with thrombosis of unknown origin, PNH may be an underlying cause. /95f654c41ed13189e89bd91c252256e8 13 0 R Hill A, Richards S, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. Soliris is generally well tolerated. 5. Although not all of these side effects may occur, if they do occur they may need medical attention. "We are pleased that eculizumab continues to show a sustained reduction in hemolysis, beneficial effects on kidney function, and a significant improvement in quality of life.". /L 68936 /Linearized 1 /O 17 Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." /T 68605 Nishimura J, et al. Kanakura, Y, et al. /Prev 68594 Check with your doctor or nurse immediately if any of the following side effects occur while taking eculizumab: More common. Soliris treatment continued to appear to be safe and well-tolerated in treated patients during the initial 26-weeks of the extension study. 1. /Filter /FlateDecode Parker C, Omine M, Richards S, et al. 14 15 0000001823 00000 n >> Socié G, Mary J Yves, de Gramont A, et al. Tell your doctor about any side effect that bothers you or that does not go away. How does Soliris work? During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection. Headache and nasopharyngitis were the most common adverse events, as seen in 37.6% and 31.6% of patients, respectively. Find patient medical information for Soliris intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Wang H, Chuhjo T, Yasue S, Omine M, Naka S. Clinical significance of a minor population of paroxysmal nocturnal hemoglobinuria-type cells in bone marrow failure syndrome. Home » Long » Long-term Soliris Therapy Leads to Sustained Muscle Strength... - Myasthenia Gravis News. 0000019328 00000 n (6) It is estimated that approximately one-third of patients with PNH do not survive more than five years from the time of diagnosis. SOLIRIS is the first and only complement inhibitor approved for adults with anti-acetylcholine receptor antibody-positive (AChR+) generalized Myasthenia Gravis (gMG), a chronic and debilitating neuromuscular disorder. 0000022683 00000 n /Pages 10 0 R /E 56035 0000002059 00000 n ", "Chronic kidney disease is one of the most common and life-threatening complications of hemolysis among Japanese patients with PNH. 2. Diarrhea 6. Diagnosis and management of paroxysmal nocturnal hemoglobinuria. << /OpenAction [ 17 0 R LDH decreased 87% from a median of 1,814 U/L at baseline to a median of 232 U/L at 38 weeks of treatment (p<0.001). 68 Since Soliris therapy increases the number of PNH cells [in study 1, the proportion of PNH RBCs increased 69 among Soliris-treated patients by a median of 28% from baseline (range from -25% to 69%)], patients who 70 discontinue treatment with Soliris may be at increased risk for serious hemolysis. Medicine 2004; 83 (3): 193-207. 0000001112 00000 n PNH is an ultra-rare blood disorder that strikes people of all ages, with an average age of onset in the early 30s. The most frequent AEs were nasopharyngitis (52%), headache (19%), blood alkaline phosphatase increases (19%) and anemia (11%). /Length 94 Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. © 2021 Alexion Pharmaceuticals, Inc. 51st Annual Meeting of the American Society of Hematology (ASH), "Chronic Renal Insufficiency in Japanese Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH): Improvement with Eculizumab Treatment in the Long-Term Follow-up of the AEGIS Study. Serious hemolysis is identified "The long-term data from the AEGIS study continue to be consistent with those observed in the SHEPHERD and TRIUMPH Phase III clinical trials, which also showed significant reductions in hemolysis, anemia, transfusion dependence, and fatigue among patients with PNH in the U.S. and Europe who were treated with Soliris," said Leonard Bell, M.D., Chief Executive Officer of Alexion. Headaches are very common adverse effects, occurring in more than 10% of people who take the drug. Tell your doctor about any side effect that bothers you or that does not go away. Intense Abdominal Pain 10. /Type /XRef Back pain. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Br J Haematol. (3) Patients with PNH suffer from hemolysis (red blood cell destruction) which leads to thromboses (blood clots), disabling fatigue, anemia, impaired quality of life, pulmonary hypertension, shortness of breath, recurrent pain, kidney disease and intermittent episodes of dark-colored urine (hemoglobinuria). Alexion Pharmaceuticals, Inc. is a biopharmaceutical company working to develop and deliver life-changing drug therapies for patients with serious and life-threatening medical conditions. Other studies have shown that kidney disease accounts for 18 percent of deaths among Japanese patients with PNH. Relationship between bone marrow failure syndromes and the presence of glycophosphatidyl inositol-anchored protein-deficient clones. Two-thirds (19/29) of patients enrolled in the AEGIS study demonstrated evidence of CKD at baseline prior to eculizumab. 4. This news release contains forward-looking statements, including statements related to potential health and medical benefits from Soliris (eculizumab). No adverse side effects of Soliris treatment were reported. << 0000001710 00000 n Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. 0 Long-term Soliris Therapy Leads to Sustained Muscle Strength Improvement, Studies Show 1,2 SOLIRIS is the first and only complement inhibitor approved for the treatment of adult patients with gMG who are AChR+. Natural history of paroxysmal nocturnal hemoglobinuria. 14 0 obj Tell your doctor if you have serious side effects of Soliris including: signs of infection (such as fever, persistent cough or sore throat, painful or frequent urination ), muscle cramps, swelling hands/ankles/feet, fast heartbeat, or changes in the amount of urine. Br J Haematol. Alexion is engaged in the discovery, development and commercialization of therapeutic products aimed at treating patients with a wide array of severe disease states, including hematologic and kidney diseases, transplant, cancer, and autoimmune disorders. The study showed that after 38 weeks of Soliris treatment, all patients with chronic kidney disease (CKD), a clinical consequence of chronic hemolysis, either stabilized or improved. Initial efficacy and safety data from the 12-week AEGIS study were presented at the ASH meeting in 2008. Inflammation Of The Tissue Lining The Sinuses 9. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Pain In The Muscles Or Bones 14. Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. /Outlines 9 0 R You may report side effects to FDA at 1-800-FDA-1088. Maciejewski JP, Risitano AM, Sloand EM, et al. Along with its needed effects, eculizumab may cause some unwanted effects. 0000015774 00000 n Thirteen patients continued into the long-term extension study and were evaluated at 64 weeks median duration of Soliris treatment (range of 2-90 weeks). Soliris is generally well tolerated. (4) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. Meningococcal infection may become rapidly life- threatening or fatal if not recognized and treated early. Alexion Announces Publication of Interim Data from Phase 3 Open-Label Extension Study Supporting Long-Term Efficacy and Safety of SOLIRIS ... or stop SOLIRIS. GETTING STARTED Beginning treatment with Soliris ® (eculizumab). The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). N Engl J Med. For more information, ask your doctor or … Soliris®terms and conditions. Soliris is used to treat adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). This 26-week extension study, which is still ongoing, further evaluated Soliris in Japanese patients with PNH and allowed for a comparison with the results from the Phase III, multinational trials conducted in the United States and Europe. 2005;106 (12):3699-3709. 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. “These long-term extension studies show that early and chronic treatment with Soliris leads to continued improvement in patient outcomes for up to two years, as demonstrated by continued inhibition of complement-mediated TMA, and improvement in renal function,” said Leonard Bell, M.D., Chief Executive Officer of Alexion. << Thirteen patients (59%) discontinued Soliris treatment following complete blood and kidney recovery. Long-Term Soliris(R) Treatment Resulted in Sustained Reduction in Hemolysis and Improved Kidney Function in Japanese Patients with PNH. Muscle Pain 12. These are not all the possible side effects of SOLIRIS. CHESHIRE, Conn., Dec 05, 2009 (BUSINESS WIRE) -- Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced positive data from the 26-week extension of the AEGIS study, an open-label registration study examining Soliris(R) (eculizumab) for the treatment of Japanese patients with paroxysmal nocturnal hemoglobinuria (PNH). 1995; 333:1253-1258. (1) In the studied patients, Soliris therapy was also associated with a sustained reduction in hemolysis, which resulted in a further improvement in levels of fatigue, as well as a maintained improvement in anemia and a reduction in transfusion requirements. Forward-looking statements are subject to factors that may cause Alexion's results and plans to differ from those expected, including for example, decisions of regulatory authorities regarding marketing approval or material limitations on the marketing of Soliris, delays in arranging satisfactory manufacturing capability and establishing commercial infrastructure, delays in developing or adverse changes in commercial relationships, the possibility that results of published reports or clinical trials are not predictive of safety and efficacy results of Soliris in broader patient populations, the risk that clinical trials may not be completed successfully, the possibility that initial results of commercialization are not predictive of future rates of adoption of Soliris, the risk that third parties won't agree to license any necessary intellectual property to Alexion on reasonable terms or at all, the risk that third party payors will not reimburse for the use of Soliris at acceptable rates or at all, and a variety of other risks set forth from time to time in Alexion's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended September 30, 2009, and in Alexion's other filings with the Securities and Exchange Commission. Life-threatening and fatal meningococcal infections have occurred in … 0000001943 00000 n Cough 5. Throat Irritation 15. /Length 0 Paroxysmal nocturnal haemoglobinuria clones in patients with myelodysplastic syndromes. 0000001602 00000 n 8. Among the 9 patients who showed improvement, 8 had stage 1-2 CKD at baseline and one had stage 3-5 at baseline. stream /S 100 Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). ... and long -term immune therapies with immunosuppressive agents such as corticosteroids, azathioprine (AZA), and cyclosporine (CYC). A significant improvement in chronic kidney disease (CKD) stage was also seen in Japanese patients on long-term Soliris treatment. About Soliris Soliris ® (eculizumab) is approved by the FDA. Other reported long-term symptoms include: Difficulty with thinking and concentration (sometimes referred to as “brain fog”) Most adverse events (AEs) were mild in severity. 15 0 obj These are not all the possible side effects of SOLIRIS. Presented at the 51st Annual Meeting of the American Society of Hematology, December 5, 2009; Poster Board # I-1002 [Blood 2009;114:1980].
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