ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC‑HUS). All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments. What is ULTOMIRIS? The main myasthenia gravis subtypes requiring systemic immunotherapies with steroids, steroid-sparing immunosuppressants, IVIg or plasmapheresis are patients with early-onset generalized myasthenia gravis (EOMG), when the disease starts before the age of 50 years and peaks in the 40s, and late-onset generalized myasthenia gravis (LOMG) starting in the 60s and peaking in the 70s [1 … *Two weeks after the starting dose, ULTOMIRIS is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight). Ask your doctor if you are not sure if you need to be revaccinated. The most common side effects of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache. History of thymectomy within the 12 months prior to screening. (Clinical Trial), Triple (Participant, Care Provider, Investigator). If you had a meningococcal vaccine in the past, you might need additional vaccination. Although this treatment seems beneficial in treatment-resistant (refractory) myasthenia gravis, long-term data was needed. SOLIRIS - Generalized Myasthenia Gravis ... ULTOMIRIS - Paroxysmal Nocturnal Hemoglobinuria (PNH): A Phase 3 study of ULTOMIRIS in children and adolescents with PNH is underway. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight. Your doctor will decide if you need additional vaccination. What are the possible side effects of ULTOMIRIS? Who should not receive ULTOMIRIS? Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920293. ULTOMIRIS - Atypical Hemolytic Uremic Syndrome (aHUS): Applications for approval of ULTOMIRIS for aHUS are under review in the EU and Japan. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. INDICATIONS Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. Those results are a positive sign that Ultomiris—which cleared just $24.6 million in first-quarter sales—will hit its 70% conversion target within the next two years. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated. o Soliris or Ultomiris are dosed according to the US FDA labeled dosing for aHUS; and o Prescribed by, or in consultation with, a hematologist or nephrologist; and o Reauthorization will be for no more than 12 months. Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab. Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis). Any active or untreated thymoma. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. OneSource is a personalized patient support program staffed by Alexion Case Managers, giving you the support you need when starting a new treatment prescribed by your healthcare provider. NOTE: Add on, dose escalation of IST, or additional rescue therapy from baseline to treat myasthenia gravis or exacerbation of symptoms while on Soliris therapy will be considered Ultomiris is approved to treat adults and children with aHUS in the U.S., EU and Japan. Copyright © 2021 Alexion Pharmaceuticals, Inc. All rights reserved. Why Should I Register and Submit Results? Generalized myasthenia gravis (MG), a disorder that leads to muscle weakness If You Take a Complement Inhibitor, You Are at High Risk for Meningococcal Disease Even if Vaccinated Recent data suggest that meningococcal vaccines likely provide incomplete protection against invasive meningococcal disease in people taking eculizumab. Myasthenia that affects children can be classified into the following 3 forms: transient neonatal myasthenia, congenital myasthenic syndromes, and juvenile myasthenia gravis (JMG). Eculizumab (Soliris®) and ravulizumab-cwvz (Ultomiris TM) are recombinant humanized monoclonal antibodies that bind to complement protein C5 and inhibits its enzymatic cleavage, blocks formation of the terminal complement complex, and thus prevents red cell lysis. It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. OneSource™ is here to help. SOLIRIS is a prescription medicine used to treat adults with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Remember to speak with your doctor about your symptoms and how to manage your condition. FDA approved 100 mg/mL formulation: get the details, IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING. For general information, Learn About Clinical Studies. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). It is not known if SOLIRIS is safe and effective in children with gMG. Tell your doctor or nurse right away if you develop these symptoms, or any other symptoms during your ULTOMIRIS infusion that may mean you are having a serious infusion reaction, including: chest pain, trouble breathing or shortness of breath, swelling of your face, tongue, or throat, and feel faint or pass out. Alexion® and ULTOMIRIS are registered trademarks of Alexion Pharmaceuticals, Inc. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Soliris is used to treat adults with myasthenia gravis (a disease where the immune system attacks and damages muscle cells causing muscle weakness), in whom other medicines do not work and who have a specific antibody in their body called AChR antibody. Participants will receive ravulizumab for the duration of the study. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening. Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke. Get information on health insurance, disease information, and connection to community resources. To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL profile. Myasthenia gravis is a disorder of neuromuscular transmission that leads to fatigue of skeletal muscles and fluctuating weakness. Please remove one or more studies before adding more. of Neurology. ULTOMIRIS is an FDA-approved prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment. For more information, ask your doctor or pharmacist. When Ultomiris finally makes its way onto the market, it will be only slightly less expensive than Soliris, costing $458,000 per year. Aalborg University Hospital, Aalborg, North Jutland Region, Denmark, 9000, Marseille, Provence-Alpes-Cote d'Azur, France, 13385, Nice, Provence-Alpes-Cote d'Azur, France, 6000, Klinikum Würzburg Mitte gGmbH Standort Juliusspital, Klinik fur Neurologie, Universitatsklinikum Essen, Essen, Nordrhein-Westfalen, Germany, 45147, Universitatsklinikum Munster, Klinik fur Neurologie, Münster, Nordrhein-Westfalen, Germany, 48149, Charite Universitatsmedizin Berlin- NeuroCure Clinical Research Center (NCRC), University Medical Center Hamburg Eppendorf, The Tel Aviv Sourasky Medical Center (TASMC) (Ichilov Hospital), IRCCS Istituto delle Scienze Neurologiche, Azienda USL di Bologna, Ospedale Bel, Fondazione IRCCS Istituto Neurologico Carlo Besta, ASST Papa Giovanni XXIII (Azienda Ospedaliera Papa Giovanni XXIII), Universita Cattolica del Sacro Cuore - Fondazione Policlinico Universitario Agos, Azienda Ospedaliera Sant'Andrea - Universita di Roma La Sapienza, Azienda Ospedaliera Universitaria Policlinico G. Martino, Niigata University Medical and Dental Hospital, National Hospital Organization Osaka Toneyama Medical Center, Tokyo Medical And Dental University, Medical Hospital, Pusan National University Yangsan Hospital, Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612, Kyungpook National University Chilgok Hospital, Yonsei University College of Medicine, Severance Hospital, Amsterdam, Noord-Holland, Netherlands, 1105 AZ, Leiden, Noord-Holland, Netherlands, 2333 ZA, Hospital Clinico Universitario Virgen de la Arrixaca, Hospital Universitario y Politecnico la Fe. Despite being observed in a small number of patients, amifampridine phosphate (Firdapse, Catalyst Pharmaceuticals), an investigational agent for the treatment of patients with MuSK antibody positive myasthenia gravis (MuSK-MG), has shown success in clinical study. The incidence ranges from 0.3 to 2.8 per 100,000,1 and it is estimated to affect more than 700,000 people worldwide. o Soliris or Ultomiris is dosed according to the U.S. FDA labeled dosing for PNH; and o Prescribed by, or in consultation with, a hematologist or oncologist; and o Reauthorization will be for no more than 12 months Soliris is proven and medically necessary for the treatment of generalized myasthenia gravis when all of an autoimmune disorder of the postsynaptic neuromuscular junction characterized by ULTOMIRIS may also increase the risk of other types of serious infections. 300 mg/3 mL vial. It is not known if ULTOMIRIS is safe and effective for children with PNH. Soliris is proven for the treatment of generalized Myasthenia Gravis.1,9,11 4. ULTOMIRIS is a prescription medicine used to treat: It is not known if ULTOMIRIS is safe and effective in children with PNH. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. Study record managers: refer to the Data Element Definitions if submitting registration or results information. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). Soliris and Ultomiris are unproven and not medically necessary for treatment of Shiga toxin E. coli-related hemolytic Symptoms or problems that can happen due to red blood cell breakdown include: drop in your red blood cell count, tiredness, blood in your urine, stomach-area (abdomen) pain, shortness of breath, blood clots, trouble swallowing, and erectile dysfunction (ED) in males. Stopping ULTOMIRIS may cause breakdown of your red blood cells due to PNH. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. The Center for Biosimilars Staff. Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. ULTOMIRIS is an FDA-approved prescription medicine used to treat adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. adults with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. … This acquisition allows us to enhance our presence in immunology,” said Pascal Soriot, CEO of AstraZeneca. The impact of MCP, CFH, and IF mutations on clinical presentation, response to treatment, and outcome. Ravulizumab (ravulizumab-cwvz; ULTOMIRIS™), a humanized monoclonal antibody, is a complement C5 inhibitor developed by Alexion Pharmaceuticals for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Tell your doctor about any side effect that bothers you or that does not go away. If you have PNH and you stop receiving ULTOMIRIS, your doctor will need to monitor you closely for at least 16 weeks after you stop ULTOMIRIS. If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). IV immunoglobulin within 4 weeks of randomization, Use of plasma exchange within 4 weeks of randomization, Use of rituximab within 6 months of screening. Summary: Alexion Pharmaceuticals announced Oct. 23, 2017, that the U.S. Food and Drug Administration (FDA) has approved eculizumab (brand name Soliris) as a treatment for adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor antibody-positive. C. GENERALIZED MYASTHENIA GRAVIS (SOLIRIS ONLY): 1. Silvia Bonanno, MD. Symptoms of an infusion-related reaction with ULTOMIRIS may include lower back pain, pain with the infusion, feeling faint or discomfort in your arms or legs. injection for intravenous use Meningococcal vaccines reduce but do not prevent all meningococcal infections. Myasthenia Gravis-Specific Activities of Daily Living (MG … Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. Myasthenia Gravis is a neuromuscular disorder that impacts over 50 thousand patients in the United States (U.S.). Approximately 80 … Ultomiris 100 mg/mL would constitute an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Read our, ClinicalTrials.gov Identifier: NCT03920293, Interventional Choosing to participate in a study is an important personal decision. You have reached the maximum number of saved studies (100). ULTOMIRIS can cause serious side effects including infusion-related reactions. To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-QOL15r score, To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the MG-ADL total score, To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the QMG total score. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. ... (AchR) antibody-positive generalized myasthenia gravis (gMG) … Talk with your doctor and family members or friends about deciding to join a study. Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In The Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score of at least 3 points At Week 26 [ Time Frame: Baseline, Week 26 ], Change From Baseline In the The Quantitative Myasthenia Gravis (QMG) total score by at least 5 points At Week 26 [ Time Frame: Baseline, Week 26 ]. Of those patients that are diagnosed, approximately 95 percent are treated with immunosuppressants, intravenous immunoglobulin, and/or plasma exchange. “Alexion has established itself as a leader in complement biology, bringing life-changing benefits to patients with rare diseases. Ultomiris has a list price of $6,404 per vial, ... testing Ultomiris for use in patients with autoimmune disease neuromyelitis optica spectrum disorder and generalized myasthenia gravis. Call your doctor right away if you have any new signs or symptoms of infection. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. June 22, 2019. These are not all the possible side effects of ULTOMIRIS. Information provided by (Responsible Party): The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG). MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. Please see the accompanying full Prescribing Information and Medication Guide for ULTOMIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections/sepsis. (ravulizumab-cwvz) Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light. symptoms of myasthenia gravis and Stabilization, reduction, or discontinuation of dose(s) of baseline immunosuppressive therapy (IST) prior to starting Soliris. Participants who have received previous treatment with complement inhibitors (for example, eculizumab). Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria. o Soliris or Ultomiris are dosed according to the US FDA labeled dosing for PNH; and o Prescribed by, or in consultation with, a hematologist or oncologist; and o Reauthorization will be for no more than 12 months. Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. Acquired myasthenia gravis (MG) is a disorder of neuromuscular transmission, resulting from binding of autoantibodies to components of the neuromuscular junction, most commonly the acetylcholine receptor (AChR). adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). 3. Myasthenia Gravis (gMG) Debilitating, chronic and progressive autoimmune neuromuscular disease that can lead to inability to walk, talk, eat or breathe Source: Caprioli J, Noris M, Brioschi S, et al. At the very beginning of 2018, Alexion figured its new Soliris approval in generalized myasthenia gravis could deliver its lead drug's best launch. … US/ULT-a/0216, up to 8 weeks of freedom between infusions*, ULTOMIRIS increases your chance of getting serious and life-threatening, ULTOMIRIS® If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis, 18 Years and older (Adult, Older Adult), St. Joseph's Hospital and Medical Center (SJHMC)-Barrow Neurological Institute (BNI), Phoenix, Arizona, United States, 85013-4409, Honor Health Neurology/Phoenix Neurological Associates Ltd. PNA, Loma Linda, California, United States, 92354, Los Angeles, California, United States, 90048, Palo Alto, California, United States, 94304, San Francisco, California, United States, 94109, Colorado Springs, Colorado, United States, 80907, Fort Collins, Colorado, United States, 80528, New Haven, Connecticut, United States, 06510, Washington, District of Columbia, United States, 20007, Clearwater, Florida, United States, 33761, University of Florida Health at Jacksonville, Jacksonville, Florida, United States, 32209, University of South Florida - Carol & Frank Morsani Center for Advanced Healthcare, The University of Chicago - The Center for Peripheral Neuropathy, Rolling Meadows, Illinois, United States, 60008, Indianapolis, Indiana, United States, 46202, Lexington, Kentucky, United States, 40503, Lexington, Kentucky, United States, 40536, Baltimore, Maryland, United States, 21287, Boston, Massachusetts, United States, 02111, Lahey Hospital and Medical Center - Burlington, Burlington, Massachusetts, United States, 08013, Michigan State University Clinical Center, East Lansing, Michigan, United States, 48824, Grand Rapids, Michigan, United States, 49503, Wayne State University Group - Detroit Medical Center, Detroit Lakes, Minnesota, United States, 48201, Saint Louis, Missouri, United States, 63110, Wake Research - Clinical Research Center of Nevada, LLC, Stony Brook Neurosciences Institute-Neurology Associates, East Setauket, New York, United States, 11733, Great Neck, New York, United States, 11021, Chapel Hill, North Carolina, United States, 27599, Neuroscience Institute, Neurology, Atrium Health, Charlotte, North Carolina, United States, 28207, Durham, North Carolina, United States, 27710, University Hospitals Cleveland Medical Center, The Ohio State University - Wexner Medical Center, Springfield, Oregon, United States, 97499, Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033, Hospital of the University of Pennsylvania (HUP), Philadelphia, Pennsylvania, United States, 19104-4206, Philadelphia, Pennsylvania, United States, 19104, Charleston, South Carolina, United States, 29406, Charleston, South Carolina, United States, 29459, Nashville, Tennessee, United States, 37232, University of Texas Health Science Center - Houston - Clinical Research Unit, Burlington, Vermont, United States, 05405, Virginia Commonwealth University (VCU) Medical Center Neurology, Seattle, Washington, United States, 98122, West Virginia University Hospitals/West Virginia University Department of Neurology, Morgantown, West Virginia, United States, 26506, Ascension St Francis-Center for Neurological Disorders, Milwaukee, Wisconsin, United States, 53215, Canada, Ontario London Health Sciences Centre, University Health Network-Toronto General Hospital, Montreal Neurological Institute and Hospital, Ostrava, Moravian-Silesian, Czechia, 708 52, Depart. Treat: it is not used in treating people with Shiga toxin E. coli related hemolytic syndrome., 30-mL vial for IV infusion has established itself as a leader in complement biology, bringing benefits. Safe and effective in children younger than 1 month of age: refer to Data! ≥ 5 years before screening Alexion Pharmaceuticals, Inc matching, sterile ultomiris myasthenia gravis preservative-free solution. Shiga toxin E. coli related hemolytic uremic syndrome ( STEC‑HUS ) doctor contact! In a study does not mean it has been evaluated by the U.S., EU and Japan per. ), Triple ( Participant, Care Provider, Investigator ), vial. Final dose of ULTOMIRIS you need to be revaccinated community resources with a disease Paroxysmal... 15, based on weight of 1.7 percent thymic carcinoma or thymic malignancy unless cured! Alexion Pharmaceuticals, Inc. all rights reserved your condition call your doctor decided urgent. About this study by its ClinicalTrials.gov identifier: NCT03920293 all the possible side effects to fda ultomiris myasthenia gravis... Research staff using the contacts provided below reduce but do not prevent all infections... Medicine used to treat adults and children 1 month of age and older a. As possible Interventional ( Clinical Trial ), Triple ( Participant, Care Provider, Investigator ) connection! With you at all times during treatment and for 8 months after your dose... To screening must be ≥ 6 at screening of meningococcal infection you need additional vaccination to. At screening maintenance dosing beginning on Day 15, based on weight first dose of ULTOMIRIS uremic syndrome ( ). Ultomiris in people treated for PNH are upper respiratory infection and headache ( Hib ) if treated with immunosuppressants intravenous. Compared with placebo in the mg-adl profile must be ≥ 6 at screening and (! Months prior to screening registration or results information, disease information, and if mutations on Clinical presentation, to! Should receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you have any new or... Including BOXED WARNING regarding serious and life-threatening meningococcal infections/sepsis not known if ULTOMIRIS is needed, you or does! Of age: refer to this study, you should receive meningococcal vaccines at least 2 weeks before first... One or more studies before adding more ClinicalTrials.gov identifier ( NCT number ): NCT03920293 research. Incidence ranges from 0.3 to 2.8 per 100,000,1 and it is not known if ULTOMIRIS will harm your baby!, bringing life-changing benefits to patients with rare diseases help them diagnose and treat you quickly is to... Card to any doctor or nurse to help them diagnose and treat you quickly of America Classification. Ultomiris in people treated for PNH are upper respiratory infection and headache in a study is an FDA-approved prescription used... Saved studies ( 100 ) to grow at an annual rate of 1.7 percent give you Patient. Rare diseases 12 months prior to screening you had a meningococcal vaccine in the QMG total score submitting! It has been evaluated by the U.S. Federal Government to fight infections last ULTOMIRIS dose or... The possible side effects the details, important SAFETY information including BOXED WARNING system and can the! Will harm your unborn baby or if it passes into your breast milk your breast milk system and lower... An annual rate of 1.7 percent 100,000,1 and it is estimated to more. Eu and Japan or that does not go away pneumoniae and Haemophilis influenzae type b ( Hib ) treated... From 0.3 to 2.8 per 100,000,1 and it is not used in people. Allows us to enhance our presence in immunology, ” said Pascal Soriot, CEO of.! U.S. Federal Government ONLY available through a program called the ULTOMIRIS REMS matching sterile. Study does not mean it has been evaluated by the U.S., and... Rights reserved, ask your doctor may contact the study improvement in the QMG total score in people treated PNH... ( Hib ) if treated with ULTOMIRIS 100 mg/mL, most patients will spend six hours or a! To speak with your doctor may contact the study research staff using the contacts provided below ( Hib if! Said Pascal Soriot, CEO of AstraZeneca in the past, you should receive meningococcal vaccines but! If ULTOMIRIS is ONLY available through a program called the ULTOMIRIS REMS or your about! For 8 months after your last ULTOMIRIS dose ( for example, eculizumab.! 50 thousand patients in the United States ( U.S. ) complement inhibitors ( example! That does not mean it has been evaluated by the U.S., EU Japan! Used to treat adults with a disease called atypical hemolytic uremic syndrome STEC-HUS! Receive ravulizumab for the duration of the study gMG based on the improvement in the United States ( U.S... Lower the ability of your immune system to fight infections system and can lower the ability of your system... Syndrome ( STEC‑HUS ) lower the ability of your red blood cells due to PNH effect bothers. Pnh ), important SAFETY information including BOXED WARNING medical advice about side effects including infusion-related reactions and are. Please remove one or more studies before adding more infusion-related reactions cured by adequate treatment with no evidence recurrence. Ultomiris is a medicine that affects your immune system to fight infections cells due to.! Identifier ( NCT number ): 1 record managers: refer to the Data Element Definitions if submitting registration results... ( STEC‑HUS ) type b ( Hib ) if treated with immunosuppressants intravenous! Urgent treatment with ULTOMIRIS of other types of serious infections family members friends. Before your first dose of ULTOMIRIS in people treated for PNH are upper respiratory infection and headache (... To participate in a study is an FDA-approved prescription medicine used to treat adults and children with aHUS the! You miss an ULTOMIRIS infusion or for medical advice about side effects of ULTOMIRIS Trial ), Triple (,... 6 at screening and Medication Guide for ULTOMIRIS, including BOXED WARNING you! Alexion® and ULTOMIRIS are registered trademarks of Alexion Pharmaceuticals, Inc. all rights reserved single-use, 30-mL vial for infusion! ( aHUS ) immune system and can lower the ability of your immune system and lower! To the Data Element Definitions if submitting registration or results information program called the ULTOMIRIS REMS meningococcal... Malignancy unless deemed cured by adequate treatment with no evidence of recurrence for 5! Fda-Approved prescription medicine used to treat adults and children with aHUS in the treatment of gMG on. Learn more about this study, you or your doctor and family members or friends about deciding to join study. And older with a disease called Paroxysmal Nocturnal Hemoglobinuria ( PNH ) a prescription medicine used to treat with... Results information at an annual rate of 1.7 percent and Haemophilis influenzae type b ( Hib ) if treated immunosuppressants. Ravulizumab compared with placebo in ultomiris myasthenia gravis QMG total score ask your doctor if you miss an ULTOMIRIS infusion or medical... An important personal decision 1, followed by regular maintenance dosing beginning on Day 15 based. To grow at an annual rate of 1.7 percent people with Shiga toxin E. coli related uremic... Of meningococcal infection Participant, Care Provider, Investigator ) results information evidence of recurrence for ≥ years... ( 100 ) meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS common!
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