You are encouraged to report negative side effects of prescription drugs to the FDA. It is not known if Soliris is safe and effective in children with NMOSD. Copyright © 2019, Alexion Pharmaceuticals, Inc. All rights reserved. Use the doctor discussion guide to get the conversation started with your doctor. Other Systemic Infections Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active PI documents can be found by searching this website or by using the PI search database in eBusiness Services. CHOLBAM ® (cholic acid) capsules is a medicine that can help these conditions.. CHOLBAM ® is a bile acid indicated for: . ULTOMIRIS is the first and only long-acting complement inhibitor for atypical-HUS in adult and pediatric patients 1 month of age and older. Limitation of Use adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). are pregnant or plan to become pregnant. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Ask your doctor if you are not sure if you need to be revaccinated. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. 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. This link will take you to a different site that is owned and operated by an independent third party to which this Privacy Policy does not apply. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). All physicians who intend to prescribe Soliris must ensure they are familiar with the physician's guide to prescribing. By using our website, you agree to our use of cookies in accordance with our, I agree to my personal data being processed in accordance with the attached. Building a community of people who know what you’re going through can be key for patients and caregivers. 2993 0 obj <> endobj SOLIRIS and NMOSD. 1 b Not indicated for STEC‑HUS 1 You are now leaving SolirisNMOSD.com, a website provided by Alexion Pharmaceuticals, Inc. Please see Summary of Product Characteristics for full prescribing information for Soliris, including all … Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. This information is intended for U.S. Healthcare Professionals. have all recommended vaccinations before you start SOLIRIS, receive 2 weeks of antibiotics if you immediately start SOLIRIS, stay up-to-date with all recommended vaccinations during treatment with SOLIRIS, common cold (upper respiratory infection), pain or swelling of your nose or throat (nasopharyngitis), flu like symptoms (influenza) including fever, headache, tiredness, cough, sore throat, and body aches, adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. You can enter the product name, licence details, sponsor details, active ingredient names or the ARTG number to get results. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), … HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SOLIRIS safely and effectively. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Soliris is covered by most insurance plans. are breastfeeding or plan to breastfeed. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. See Important Safety Information, including Boxed Warning, and full Prescribing Information. SOLIRIS is used to treat: adults with a disease called generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive It is not known if SOLIRIS is safe and effective in children with gMG. Soliris is only available through a restricted program called the SOLIRIS REMS (Risk Evaluation and Mitigation Strategy). Soliris is a prescription medicine called a monoclonal antibody. The Prescribing Information for Soliris recommends that patients and healthcare providers comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies. make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. Eliza Dollard, PharmD August 2015 Eculizumab (Soliris®) Procedure for Use in Patients Age ≥ 18 Years Jackson Memorial Hospital Eculizumab Prescribing Procedure: All prescribers must be enrolled in the Soliris REMS (Risk Evaluation and Mitigation Strategy) Program o Additional REMS information and enrollment instructions can be found at www.solirisrems.com Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Certain people may be at risk of serious infections with gonorrhea. Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card. Resources for your patients on Soliris® (eculizumab). This link will take you to a different site that is owned and operated by an independent third party to which this Privacy Policy does not apply. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Soliris® (eculizumab) Concentrated solution for intravenous infusion . 1 SOLIRIS is the first and only FDA-approved drug for the treatment of NMOSD in adult patients who are anti-AQP4 antibody positive. Print and sign the Prescriber Enrollment Form Mail the form to Soliris REMS, Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210. 1.2 Atypical Hemolytic Uremic Syndrome (aHUS) Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Soliris safely and effectively. You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine. Please see the full SOLIRIS Product Information, including information regarding meningococcal infection and other serious infections (including sepsis) 10 Administering Soliris to patients 1 SOLIRIS is supplied as a 300 mg single-use vial. SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. reduction in risk of relapse in adults treated with Soliris compared to placebo, were relapse-free after ~1 year vs 63% with placebo. h�b```��,�� ���� For more information, ask your doctor or pharmacist. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. To become certified, prescribers must: 1) Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. It is important to show this card to any doctor or nurse who treats you. %PDF-1.6 %���� See “How will I receive SOLIRIS?” in the Medication Guide. Initial U.S. Approval: 2007 . 3065 0 obj <>stream It is not known if SOLIRIS is safe and effective in children with NMOSD. 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. SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). 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. 1,b a Starting 2 weeks after the loading dose, maintenance doses are administered once every 4 or 8 weeks (depending on body weight). Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. We will work with you to find the best option. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD. What is the most important information I should know about SOLIRIS? Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Keep a list of them to show your doctor and pharmacist when you get a new medicine. For further information call emc accessibility on 0800 198 5000. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. It is not known if SOLIRIS will harm your unborn baby. SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. That’s why we’re developing events near you as well as online webinars you can join from home. Know the medications you take and the vaccines you receive. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. Your doctor will decide if you need additional meningococcal vaccination. These are not all the possible side effects of SOLIRIS. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS SOLIRIS (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007 . Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. Where availablelinks to product information (PI) pdf documents are provided. 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. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: Important update: Information on COVID-19 from Alexion. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. See full prescribing information for SOLIRIS. When your patient enrolls in the OneSource program, they will be assigned to a dedicated OneSource Case Manager who can help them with: Whether you are newly diagnosed or have had multiple relapses, see how it may be able to help you control your NMOSD. These are not all the possible side effects of SOLIRIS. You may report side effects to FDA at 1-800-FDA-1088. 3011 0 obj <>/Filter/FlateDecode/ID[]/Index[2993 73]/Info 2992 0 R/Length 98/Prev 771931/Root 2994 0 R/Size 3066/Type/XRef/W[1 3 1]>>stream Soliris® (eculizumab) 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. Sign up to get the latest news and information about anti-AQP4 antibody-positive NMOSD relapses and how Soliris can help. We use cookies to give you the best online experience. Below is a text only representation of the Patient Information Leaflet. Call your doctor for medical advice about side effects. SOLIRIS and other medicines can affect each other causing side effects. Fax the form to Soliris REMS at 1-877-580-2596 (ALXN); or Scan and email the form to rems@alexion.com Contraindications . Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 2 Patients should be immunized with meningococcal vaccines at least 2 weeks prior to receiving the first dose of Soliris. Visit MedWatch, or call 1-800-FDA-1088. This site is intended for patients and caregivers. Soliris is a prescription medicine called a monoclonal antibody. SOLIRIS is used to treat: adults with a disease called neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive It is not known if SOLIRIS is safe and effective in children with NMOSD. Physicians must discuss the benefits and risks of Soliris therapy with patients and provide them with a patient information brochure and a patient safety card (see Package Leaflet for a description). General information about the safe and effective use of SOLIRIS. These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications.