No thrombotic events or meningococcal infections were reported during Soliris treatment. "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.". /O 17 Parker C, Omine M, Richards S, et al. >> 6. 14 15 For more information, ask your doctor or … Soliris should be given for life unless the patient develops serious side effects. /Root 15 0 R PNH often goes unrecognized, with delays in diagnosis ranging from one to more than 10 years. Please see Important Safety Information and full Prescribing Information, including Boxed Warning, and Medication Guide. /Filter /FlateDecode The most common side effect with Soliris (seen in more than 1 patient in 10) is headache. Pain In The Muscles Or Bones 14. Soliris®terms and conditions. 2002;100 (12):3897-3902. 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. 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. Maciejewski JP, Risitano AM, Sloand EM, et al. Br J Haematol. /Info 11 0 R Cough 5. Soliris is generally well tolerated. In this extension study, clinical improvements in kidney function with eculizumab therapy were particularly evident in patients with early stage kidney disease, which underscores the importance of early intervention with eculizumab," said Yuzuru Kanakura, M.D., Ph.D., Professor of Hematology and Oncology at Osaka University Hospital in Suita, Japan, and lead author of the study. Most adverse events (AEs) were mild in severity. Soliris is generally well tolerated. /E 56035 >> Nishimura J, et al. 2. << Check with your doctor or nurse immediately if any of the following side effects occur while taking eculizumab: More common. Alexion Announces Publication of Interim Data from Phase 3 Open-Label Extension Study Supporting Long-Term Efficacy and Safety of SOLIRIS ... or stop SOLIRIS. 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. (4) PNH develops without warning and can occur in men and women of all races, backgrounds and ages. Paroxysmal nocturnal haemoglobinuria: long-term follow-up and prognostic factors. Blood. Meningococcal infection may become rapidly life- threatening or fatal if not recognized and treated early. 0000001602 00000 n Prior to these approvals, there were no therapies specifically available for the treatment of PNH. These are not all the possible side effects of SOLIRIS. While 10 of them remained in disease remission, three (23%) relapsed within one year after treatment was discontinued. /N 4 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. “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. Along with its needed effects, eculizumab may cause some unwanted effects. ", Clinical Data from the AEGIS Extension Study, Twenty-seven Japanese patients entered the extension of the AEGIS study. This website is intended only for residents of the United States. –Vaccinate patients with a meningococcal vaccine at least 2 weeks prior to receiving the first dose of SOLIRIS®. ". PNH is an ultra-rare blood disorder that strikes people of all ages, with an average age of onset in the early 30s. 3. GETTING STARTED Beginning treatment with Soliris ® (eculizumab). 5. 1,2 SOLIRIS is the first and only complement inhibitor approved for the treatment of adult patients with gMG who are AChR+. (3) More information on PNH is available at www.pnhsource.com. 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. /ID [ (sobbkvoqhqosctuv) More information on Soliris is available at www.soliris.net. N Engl J Med. 0000002273 00000 n Laboratory tests to evaluate the long-term treatment effects of Soliris (eculizumab) on complement inhibition — stopping an overly aggressive immune response — in patients with atypical hemolytic uremic syndrome (aHUS) are useful, a case report shows. WARNING: SERIOUS MENINGOCOCCAL INFECTION. Urinary Tract Infection 16. 8. The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Throat Irritation 15. 1996: 348:573-577. 0000001710 00000 n Backache 3. << /ABCpdf 5008 Home » Long » Long-term Soliris Therapy Leads to Sustained Muscle Strength... - Myasthenia Gravis News. SOLIRIS®increases the risk of meningococcal infections. Nausea 13. 0000000012 00000 n These are not all the possible side effects of SOLIRIS. EU/3/03/166 on 17 October 2003. 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. 16 0 obj %%EOF (7,8,9) In patients with thrombosis of unknown origin, PNH may be an underlying cause. If experienced, these tend to have a Severe expression 1. Learn how to prepare for treatment, what you may expect throughout, and tools and resources available to help you manage your anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) long-term. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Relationship between bone marrow failure syndromes and the presence of glycophosphatidyl inositol-anchored protein-deficient clones. /Type /XRef 2005;106 (12):3699-3709. /Size 29 Headaches are very common adverse effects, occurring in more than 10% of people who take the drug. Long-term Soliris Therapy Leads to Sustained Muscle Strength Improvement, Studies Show These are not all the possible side effects of SOLIRIS. You may report side effects to FDA at 1-800-FDA-1088. By Srogo Mon Friday, July 24, 2020 Long. Although not all of these side effects may occur, if they do occur they may need medical attention. "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. During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection. Blood. Low Energy 11. stream 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) 2001;115:1015-1022. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. << (6) PNH has been identified more commonly among patients with disorders of the bone marrow, including aplastic anemia (AA) and myelodysplastic syndromes (MDS). The type of pneumonia often associated with COVID-19 can cause long-standing damage to the tiny air sacs (alveoli) in the lungs. Presented at the 51st Annual Meeting of the American Society of Hematology, December 5, 2009; Poster Board # I-1002 [Blood 2009;114:1980]. (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. Find patient medical information for Soliris intravenous on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Two-thirds (19/29) of patients enrolled in the AEGIS study demonstrated evidence of CKD at baseline prior to eculizumab. /H [ 1112 187 ] Results showed that there was a sustained reduction in intravascular hemolysis, as measured by lactate dehydrogenase (LDH), through the 38 weeks of treatment. Further, 53% (9/17) of patients with CKD at baseline demonstrated improvement. /L 68936 Hill A, Richards S, Hillmen P. Recent developments in the understanding and management of paroxysmal nocturnal haemoglobinuria. 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. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." This news release contains forward-looking statements, including statements related to potential health and medical benefits from Soliris (eculizumab). /OpenAction [ 17 0 R /Dests << 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. /PageMode /UseNone No adverse side effects of Soliris treatment were reported. xref 0000015774 00000 n /S 100 7. Clinical course and flow cytometric analysis of paroxysmal nocturnal hemoglobinuria in the United States and Japan. 0000015930 00000 n We use cookies to give you the best online experience. A Common Cold 2. 0000019328 00000 n >> >> ", "Chronic kidney disease is one of the most common and life-threatening complications of hemolysis among Japanese patients with PNH. The most common side effects in people with gMG treated with SOLIRIS include: muscle and joint (musculoskeletal) pain. (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). (4,5) Approximately 10 percent of all patients first develop symptoms at 21 years of age or younger. Soliris treatment continued to appear to be safe and well-tolerated in treated patients during the initial 26-weeks of the extension study. The resulting scar tissue can lead to long-term breathing problems. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). 1998;102 (2):465-474. 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). 4. /T 68605 endobj Initial efficacy and safety data from the 12-week AEGIS study were presented at the ASH meeting in 2008. 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. /Type /Catalog ... and long -term immune therapies with immunosuppressive agents such as corticosteroids, azathioprine (AZA), and cyclosporine (CYC). /Pages 10 0 R 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. The active substance in Soliris, eculizumab, is a monoclonal antibody (a type of protein) that has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called the ‘complement system’. Soliris is Alexion's first marketed product. How does Soliris work? Diagnosis and management of paroxysmal nocturnal hemoglobinuria. trailer Br J Haematol. (6) It is estimated that approximately one-third of patients with PNH do not survive more than five years from the time of diagnosis. Socié G, Mary J Yves, de Gramont A, et al. 0000002059 00000 n Tell your doctor about any side effect that bothers you or that does not go away. endobj 0000001943 00000 n 0000001300 00000 n 0000000929 00000 n x�c```b``�dP``��p� �)@6T� B��e`�d`��Ā`�g�. Life-threatening and fatal meningococcal infections have occurred in … 15 0 obj 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. 0000022683 00000 n 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). Other studies have shown that kidney disease accounts for 18 percent of deaths among Japanese patients with PNH. 0000001823 00000 n Headache and nasopharyngitis were the most common adverse events, as seen in 37.6% and 31.6% of patients, respectively. Lancet. Fever 7. 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. A significant improvement in chronic kidney disease (CKD) stage was also seen in Japanese patients on long-term Soliris treatment. 1995; 333:1253-1258. There are many options to minimize or prevent the side effects of Soliris. << 1. Headache 8. For the full list of all side effects reported with Soliris, see the Package Leaflet. Soliris, was designated as an orphan medicinal product . The following Soliris side effects are common (occurring in greater than 30%) for patients taking Soliris: High blood pressure For more information, ask your doctor or … Kanakura, Y, et al. Intense Abdominal Pain 10. 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. 0000001112 00000 n 0000051646 00000 n /Length 0 Hillmen P, Lewis SM, Bessler M, Luzzatto L, Dacie JV. Iwanga M, Furukawa K, Amenomori T, et al. About Soliris Soliris ® (eculizumab) is approved by the FDA. 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. Serious hemolysis is identified /Prev 68594 The long-term safety of Soliris was also demonstrated in PNH clinical development trials in which patients were treated continuously with Soliris and followed for up to 5.5 years.2 Data from an international PNH registry showed that Soliris significantly reduced the risk of thromboembolism (TE) in patients with PNH.3 Tell your doctor about any side effect that bothers you or that does not go away. /Linearized 1 Alexion does not intend to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law. /Fit ] Diarrhea 6. The most frequent AEs were nasopharyngitis (52%), headache (19%), blood alkaline phosphatase increases (19%) and anemia (11%). The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). © 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. 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). SOLIRIS and gMG. The data were presented today at the 51st Annual Meeting of the American Society of Hematology (ASH) in a poster titled "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. 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. Among the 9 patients who showed improvement, 8 had stage 1-2 CKD at baseline and one had stage 3-5 at baseline. Under the Soliris REMS, prescribers must enroll in the program. Drug companies should be thinking of the long-term effect on people who can’t even consent. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Soliris is used to treat adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). 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. Constipation 4. The most common side effects in people with gMG treated with SOLIRIS include: Muscle and joint (musculoskeletal) pain; Tell your doctor about any side effect that bothers you or that does not go away. Thirteen patients (59%) discontinued Soliris treatment following complete blood and kidney recovery. In the primary endpoint, mean platelet count increased 73x10 9 /L (P=0.0001) from baseline through week 26 and was sustained 2007;137:181-92. Soliris should not be used in people who may be hypersensitive (allergic) to eculizumab, mouse proteins or any of the other ingredients, or who have, or are thought to have, inherited deficiencies in complement. /Length 94 /95f654c41ed13189e89bd91c252256e8 13 0 R >> %PDF-1.4 Vomiting Inflammation Of The Tissue Lining The Sinuses 9. 9. Paroxysmal nocturnal haemoglobinuria clones in patients with myelodysplastic syndromes. For more information, ask your doctor or pharmacist. 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. Natural history of paroxysmal nocturnal hemoglobinuria. Call your doctor for medical advice about side effects. Anemia 2. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Muscle Pain 12. Br J Haematol. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Four patients experienced 9 serious adverse events (SAEs); one patient experienced 4 SAEs that were reported as probably or possibly related to the drug. Other reported long-term symptoms include: Difficulty with thinking and concentration (sometimes referred to as “brain fog”) startxref /Outlines 9 0 R Back pain. "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. (qzvqzbzmbixanxqh) ] Long-Term Soliris(R) Treatment Resulted in Sustained Reduction in Hemolysis and Improved Kidney Function in Japanese Patients with PNH. (2). Medicine 2004; 83 (3): 193-207. 0 At week 38, 33% (9/27) of patients showed improvement in CKD while 67% (18/27) showed no change from baseline and no patients (0%) worsened (p<0.05). 14 0 obj High Blood Pressure If experienced, these tend to have a Less Severe expression 1.
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