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 overview. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. Do not administer as an intravenous push or bolus injection. Soliris [package insert]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS , prescribers must enroll in the program (5.2). BOSTON--(BUSINESS WIRE)--Aug. 27, 2019-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the European Commission (EC) has … Under the Soliris REMS, prescribers must enroll in the program. SOLIRIS prescription and dosage sizes information for physicians and healthcare professionals. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. "Soliris provides the first FDA-approved treatment for neuromyelitis optica spectrum disorder, a debilitating disease that profoundly impacts patients' lives," said … We use cookies to give you the best online experience. Eculizumab is available as Soliris in 300 mg single‐use vials for intravenous (IV) infusion. Dosing information for Soliris® (eculizumab). Episodes of ON and myelitis can be simultaneous or successive. Dosing for patients with anti-AQP4 antibody-positive NMOSD consists of an induction phase followed by a maintenance phase.1. Last updated on Jan 29, 2021. Posted: June 6, 2013. Dosing regimen for adult patients with anti-AQP4 antibody-positive NMOSD 1. Administer Soliris ® (eculizumab) over 35 minutes at the recommended dosage regimen time points, or within 2 days of these time points. 1. Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see Warnings and Precautions (5.2)]. Soliris ® (eculizumab) is the FIRST AND ONLY FDA-approved complement inhibitor indicated for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur. 300 mg. ... Neuromyelitis Optica Spectrum Disorder. References 1. Possible good news for patients with neuromyelitis optica (aka Devic’s syndrome) and for stock holders of Alexion Pharmaceuticals. Neuromyelitis optica spectrum disorder (NMOSD) is a relapsing, autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord. Use caution when administering Soliris to patients with any systemic infection. SOLIRIS is only available through a program called the SOLIRIS REMS. The US Food and Drug Administration has approved eculizumab for the first treatment of adult patients with the rare autoimmune disease neuromyelitis optical spectrum disorder (NMOSD). For patients 18 years of age and older, Soliris therapy consists of: Administer Soliris at the recommended dosage regimen time points, or within two days of these time points [see Warnings and Precautions (5.4)]. Under the Soliris REMS, prescribers must enroll in the program. A relapsing disease course is common, especially in untreated patients. See Important Safety Information, including Boxed Warning, and full Prescribing Information. -- Soliris ® Reduced the Risk of Adjudicated On-Trial Relapse by 94.2% Compared to Placebo (p < 0.0001) ---- Safety Profile Consistent with that Seen in Previous Studies and Real-World Use ---- Preparing for Regulatory Submissions in the US, European Union, and Japan---- Conference Call/Webcast Scheduled for Today, Monday, September 24, 2018 at 8:30 a.m. EDT-- Neuromyelitis optica spectrum disorders (NMOSD) is an etiologically heterogeneous syndrome predominantly characterized by acute inflammation of the optic nerve (optic neuritis, ON) and the spinal cord (). Vaccinate patients according to current ACIP guidelines to reduce the risk of serious infection [see Warnings and Precautions (5.1 and 5.2)]. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Importance A previous 2-year analysis of repeated rituximab treatment in patients with neuromyelitis optica (NMO) revealed significant improvements in relapse rates and disability. With Soliris, A future with fewer relapses is possible. SOLIRIS is used to treat adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Prior to administration, the admixture should be allowed to adjust to room temperature [18°-25° C, 64°-77° F]. o Soliris is dosed according to the US FDA labeled dosing for gMG: up to a maximum of 1200 mg every 2 weeks; and o Prescribed by, or in consultation with, a neurologist; and o Reauthorization will be for no more than 12 months. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. Soliris-treated patients experienced similar improvement in time to first adjudicated on-trial relapse with or without concomitant IST treatment. SOLIRIS® (eculizumab) Receives Approval in Japan for the Prevention of Relapse in Patients with Neuromyelitis Optica Spectrum Disorder ... (ECU-NMO-302), which is still underway. Initially, infusions are given weekly for 4 weeks, followed by a fifth dose 1 week later. By using our website, you agree to our use of cookies in accordance with our. Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Eculizumab, sold under the brand name Soliris among others, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and neuromyelitis optica.In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Soliris is proven for the treatment … Dosing information. -- Soliris ® Reduced the Risk of Adjudicated On-Trial Relapse by 94.2% Compared to Placebo (p < 0.0001) ---- Safety Profile Consistent with that Seen in Previous Studies and Real-World Use ---- Preparing for Regulatory Submissions in the US, European Union, and Japan---- Conference Call/Webcast Scheduled for Today, Monday, September 24, 2018 at 8:30 a.m. EDT-- 1,2. Only administer as an intravenous infusion. Rituximab therapy has dramatically improved patient care, but standardized dosing regimens and guidelines are lacking. The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Plasmapheresis or plasma exchange. SOLIRIS 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. Reference ... NMO can be distinguished from multiple sclerosis on the basis of Neuromyelitis optica spectrum disorder (NMOSD) • 900mg weekly for first 4 weeks, followed by • 1200mg for the fifth dose 1 week later, then • 1200mg every 2 weeks thereafter. Three drugs have been approved by the US Food and Drug Administration (FDA) specifically for treatment of anti-AQP4 positive NMO: Soliris … It is not known if SOLIRIS … SOLIRIS is a medicine that affects your immune system. About Neuromyelitis Optica. Pharmacology, adverse reactions, warnings and side effects. For adults with anti-AQP4 antibody-positive Neuromyelitis Optica Spectrum Disorder. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Eculizumab (Soliris) for relapsing neuromyelitis optica spectrum disorders NIHR HSRIC ID: 6091 . For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: For adult and pediatric patients with aHUS, and adult patients with gMG or NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2). Each vial contains 30 mL of 10 mg/mL sterile, preservative‐free solution. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Table 9 displays the most common adverse events from Study ECU-NMO-301 that occurred in ≥ 5% of Soliris-treated patients and at a greater frequency than on placebo. The Guthy-Jackson Charitable Foundation. Risk of Discontinuation and Deviation from Recommended Dosing Schedule. We use cookies to give you the best online experience. Diagnosis of NMO or NMOSD. Expanded Disability Status Scale score ≤ 7. 2.2 Recommended Dosage Regimen – PNH For patients 18 years of age and older, Soliris therapy consists of: • 600 mg weekly for the first 4 weeks, followed by • … two (2) weeks prior to the administration of the first dose of Soliris 4. Discard any unused portion left in a vial, as the product contains no preservatives. Patients may have increased susceptibility to infections, especially with encapsulated bacteria. ... SOLIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. 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. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. It is not known if Soliris is safe and effective in children with PNH, gMG, or NMOSD. By checking this box and providing my information above, I am giving Alexion permission to contact me for marketing purposes or otherwise provide me with information about Alexion’s products, services, and programs or other topics of interest, and to conduct market research or surveys. 1. Dosing regimen consists of: 900 mg per dose, once weekly for the first 4 weeks, followed by; 1200 mg for the fifth dose 1 week later, followed by; 1200 mg per dose every 2 weeks afterwards; Q. Usual Adult Dose of Soliris for Paroxysmal Nocturnal Hemoglobinuria: Dosing occurs in 2 phases. 2.4 Recommended Dosage Regimen – gMG and NMOSD For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. ... You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you are not vaccinated. Supplemental dosing of Soliris is required in the setting of concomitant support with PE/PI (plasmapheresis or plasma exchange; or fresh frozen plasma infusion) (Table 2). The dosing regimen will be based on the participant's body weight. Soliris® injection [prescribing information]. 2.4 Recommended Dosage Regimen – gMG and NMOSD For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: • 900 mg weekly for the first 4 weeks, followed by SOLIRIS can lower the ability of your immune system to fight infections. In Study ECU-NMO-301, 96 patients received Soliris at the recommended dosage regimen and 47 patients received placebo. Table 2: Supplemental dose of Soliris after PE/PI Type of Intervention . As body weight changes during the study, the participant's weight cohort and dose may change accordingly. Soliris is currently FDA approved for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS), and for adult patients with generalized myasthenia gravis (MG) who are … Select one or more newsletters to continue. Importance A previous 2-year analysis of repeated rituximab treatment in patients with neuromyelitis optica (NMO) revealed significant improvements in relapse rates and disability. Soliris is also used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults. You may need frequent medical tests for 8 to 12 weeks if you stop using this medicine for any reason. Healthcare professionals who prescribe Soliris must enroll in the Soliris REMS [see Warnings and Precautions (5.1)]. The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Patients were 19 to 75 years of age, and 91% were female. When does dosing adjustments need to be made? Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported. If the infusion is slowed, the total infusion time should not exceed two hours in adults. This site is intended for healthcare professionals. Generic name: ECULIZUMAB 300mg in 30mLDosage form: injection, solution, concentrate. The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion. Medically reviewed by Drugs.com. In the Soliris PREVENT study of patients with anti-AQP4 antibody-positive NMOSD, Soliris was superior to placebo based on time to first adjudicated on-trial relapse (primary endpoint). Soliris can have long-lasting effects on your body (up to 3 months). See Important Safety Information, including Boxed Warning, and full Prescribing Information. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Soliris For Treating NMO. There is no cure for neuromyelitis optica (NMO) at this time. Soliris is given weekly initially and then every two or three weeks. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS, If an adverse reaction occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician, If the infusion is slowed, the total infusion time should not exceed 2 hours, Monitor the patient for at least 1 hour following completion of the infusion for signs or symptoms of an infusion reaction, For adult patients with NMOSD, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion, Patients who are not currently vaccinated against. For adult patients with generalized myasthenia gravis or neuromyelitis optica spectrum disorder, Soliris therapy consists of: 900 mg weekly for the first 4 weeks, followed by; 1200 mg for the fifth dose 1 week later, then; 1200 mg every 2 weeks thereafter. ... For acute attacks, the standard treatment is high-dose intravenous corticosteroids, ... Soliris overview. At least two thirds of cases are associated with aquaporin-4 antibodies (AQP4-IgG) and complement-mediated damage to the central nervous system. Soliris is indicated for intravenous use (300 mg/30 mL injection) in patients with NMOSD who are anti-aquaporin-4 (AQP4) antibody-positive.. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Because the likelihood of recurrence is greater than 90 percent and attacks are generally severe, ongoing treatment to suppress the immune system is considered necessary. Provide two weeks of antibacterial drug prophylaxis to patients if Soliris must be initiated immediately and vaccines are administered less than two weeks before starting Soliris therapy. Outcome Measures. This briefing is based on information available at the time of research and a limited literature search. Dosing information for Soliris® (eculizumab). 1. Soliris is indicated for the treatment of adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. Neuromyelitis optica spectrum disorder is a rare, relapsing, autoimmune, inflammatory disorder affecting the central nervous system (CNS). Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD and Soliris. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Table 1: Dosing Recommendations in aHUS Patients Less Than 18 Years of Age, Table 2: Supplemental Dose of Soliris after PE/PI, Table 3: Preparation and Reconstitution of Soliris, We comply with the HONcode standard for trustworthy health information -, 300 mg per each plasmapheresis or plasma exchange session, Within 60 minutes after each plasmapheresis or plasma exchange, 600 mg per each plasmapheresis or plasma exchange session, 300 mg per infusion of fresh frozen plasma, 60 minutes prior to each infusion of fresh frozen plasma, 600 mg weekly for the first 4 weeks, followed by, 900 mg for the fifth dose 1 week later, then, 900 mg weekly for the first 4 weeks, followed by, 1200 mg for the fifth dose 1 week later, then. We report the findings from the longest follow-up of rituximab treatment in NMO, which provide reassurance regarding the long-term efficacy and safety of rituximab in NMO. Please see Important Safety Information and full Prescribing Information, including Boxed WARNING, and Medication Guide. pyridostigmine, Mestinon, neostigmine, eculizumab, Ultomiris, satralizumab, ravulizumab, Enspryng, Prostigmin. Soliris (eculizumab) is a drug indicated for the treatment of paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uremic syndrome (aHUS), generalised myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD). Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. Extending the dosing interval of Soliris maintenance treatment from standard two weeks to three weeks may equally achieve therapeutic blood levels in most adults with atypical hemolytic uremic syndrome (aHUS), a study suggests.. Objectives: The objective of this study was to define a rituximab dosing strategy for NMO patients that achieves the lowest rate of relapses. The standard of care for an initial attack of NMO includes the following: Intravenous (into the vein) high-dose corticosteroids (methylprednisolone) Plasma Exchange (PLEX) if no improvement occurs with corticosteroids. Make sure any doctor who treats you knows that you've used Soliris. • Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion for the fifth week, followed by 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) intravenous infusion every 14 ± 2 days (see section 5.1). ... Soliris. In a previous small, open-label study involving patients with AQP4-IgG–positive disease, eculizumab, a terminal complement i… • 1200 mg for the fifth dose 1 week later, then • 1200 mg every 2 weeks thereafter. Monitor the patient for at least one hour following completion of the infusion for signs or symptoms of an infusion-related reaction. Important update: Information on COVID-19 from Alexion. Indications and Usage (1.3) 10/2017 Dosage and Administration (2.4, 2.5) 10/2017 Dosage and Administration (2.5, 2.6, 2.7) 07/2018 Alexion OneSource™ provides gMG patient support. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. First NMO Treatment Approved ... Eculizumab (Soliris), an injectable drug, was approved for NMOSD adults who are anti-aquaporin-4 (AQP4) antibody positive, the agency announced. AQP4 antibody seropositive. The goal of PLEX is to lower the level of NMO-IgG in the blood. b Dosing schedule can occasionally vary by ±7 days of the scheduled infusion day (except for the first maintenance dose of ULTOMIRIS), but the subsequent dose should be administered according to the original schedule. Withdraw the required amount of Soliris from the vial into a sterile syringe. Indicated for neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. c Body weight at time of treatment. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. The drug Soliris (eculizumab) may be a safe and effective treatment for that condition. Admixed solutions of Soliris are stable for 24 h at 2°-8° C (36°-46° F) and at room temperature. Please see Important Safety Information and full Prescribing Information, including Boxed Warning, ... Know and follow dosing schedule. The admixture must not be heated in a microwave or with any heat source other than ambient air temperature. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps: The final admixed Soliris 5 mg/mL infusion volume is 60 mL for 300 mg doses, 120 mL for 600 mg doses, 180 mL for 900 mg doses or 240 mL for 1200 mg doses (Table 3). Transfer the recommended dose to an infusion bag. Dilute Soliris to a final concentration of 5 mg/mL by adding the appropriate amount (equal volume of diluent to drug volume) of 0.9% Sodium Chloride Injection, USP; 0.45% Sodium Chloride Injection, USP; 5% Dextrose in Water Injection, USP; or Ringer's Injection, USP to the infusion bag. - New data published in NEJM confirm sustained three-year treatment effect - - Data will also be presented in Emerging Science session at American Academy of Neurology Annual Meeting - - SOLIRIS for NMOSD currently under regulatory review in the U.S., European Union and Japan; U.S. FDA Priority Review action date of June 28, 2019- BOSTON & PHILADELPHIA--(BUSINESS WIRE)--May 3, 2019-- … Supplemental Soliris Dose With Each PE/PI Intervention. Studies evaluating the safety and efficacy of eculizumab for aHUS included a total of 25 pediatric patients (ages 2 months to 17 years). Neuromyelitis optica spectrum disorder (NMOSD) • Must be prescribed by or in consultation with a neurologist • Must have a diagnosis of neuromyelitis optica spectrum disorder • Must be anti-aquaporin-4 (AQP4) antibody positive We report the findings from the longest follow-up of rituximab treatment in NMO, which provide reassurance regarding the long-term efficacy and safety of rituximab in NMO. Doses 1-4: 900 mg IV qWeek for first 4 weeks, followed by. FDA approves Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. SOLIRIS ® (eculizumab) is the first and only approved medication for NMOSD in Europe-- 98% of adult anti-aquaporin-4 (AQP4) antibody-positive patients treated with SOLIRIS were relapse free compared to 63% receiving placebo at 48 weeks -. In 2013, Soliris was granted ODD in both the U.S. and EU for the treatment of NMO. Boston, MA: Alexion Pharmaceuticals, Inc. Dosing Recommendations. Available for Android and iOS devices. Soliris is also used to treat myasthenia gravis in adults. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. Administer Soliris at the recommended dosage regimen time points, or within two days of these time points. The PNH dosing regimen for adult patients (≥18 years of age) consists of a 4-week initial phase followed by a maintenance phase: • Initial phase: 600 mg of Soliris administered via … Get started with Soliris® treatment. Figure 2: Kaplan-Meier Survival Estimates for Time to First Adjudicated On-Trial Relapse in Study ECU-NMO-301 – Full Analysis Set Administer the Soliris admixture by intravenous infusion over 35 minutes in adults and 1 to 4 hours in pediatric patients via gravity feed, a syringe-type pump, or an infusion pump. Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early. NMOSD is an autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Soliris is given as an infusion (drip) into a vein and the recommended dose depends on what it is used for, and for patients under 18 years of age, on their bodyweight. The U.S. Food and Drug Administration today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 2.5 Dose Adjustment in Case of Plasmapheresis, Plasma Exchange, or Fresh Frozen Plasma Infusion For adult and pediatric patients with aHUS and adult patients with gMG, supplemental dosing of Soliris is required in the setting of concomitant plasmapheresis or plasma exchange, or fresh frozen plasma infusion (PE/PI) (Table 2).