It is not known if SOLIRIS is safe and effective in children with gMG. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SOLIRIS safely and effectively. Soliris may be able to help reduce your risk of relapse. This will help them diagnose and treat you quickly. are breastfeeding or plan to breastfeed. If your doctor decided that urgent treatment with SOLIRIS is needed, you should receive meningococcal vaccination as soon as possible. make sure that you are vaccinated with the meningococcal vaccine and, if needed, get revaccinated with the meningococcal vaccine. When your patient enrolls in the OneSource program, they will be assigned to a dedicated OneSource Case Manager who can help them with: You must receive meningococcal vaccines at least 2 weeks before your first dose of SOLIRIS if you have not already had this vaccine. Keep a list of them to show your doctor and pharmacist when you get a new medicine. 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 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. 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. endstream endobj startxref Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), … You are now leaving SolirisNMOSD.com, a website provided by Alexion Pharmaceuticals, Inc. WARNING: SERIOUS MENINGOCOCCAL INFECTIONS The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). WARNING: SERIOUS MENINGOCOCCAL INFECTIONS You may report side effects to FDA at 1-800-FDA-1088. 2993 0 obj <> endobj 1 b Not indicated for STEC‑HUS 1 SOLIRIS is the first and only complement inhibitor approved by the FDA for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). Contraindications . SOLIRIS (eculizumab) injection, for intravenous use Initial U.S. Approval: 2007 . 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. Please enter your information below to receive updates about anti-AQP4 antibody-positive NMOSD. Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Soliris is a prescription medicine called a monoclonal antibody. The original leaflet can be viewed using the link above. %%EOF Know the medications you take and the vaccines you receive. 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. It is not known if SOLIRIS passes into your breast milk. To become certified, prescribers must: 1) Review the SOLIRIS Prescribing Information, Prescriber Safety Brochure, Patient Safety Brochure and the Patient Safety Card. Search PI documents Soliris is generally well tolerated in patients with PNH and aHUS. 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 You are now leaving Solirisinfusionfinder.com a website provided by Alexion Pharmaceuticals, Inc. Limitation of Use 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. Copyright © 2019, Alexion Pharmaceuticals, Inc. All rights reserved. Soliris treatment should not alter anticoagulant management. That’s why we’re developing events near you as well as online webinars you can join from home. ... form is a generic referral form that could be utilized for any Soliris provider and is meant to provide the pertinent information needed to process a Soliris referral. 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 Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The Soliris prescribing information contains a boxed warning that serious meningococcal infections have occurred in patients taking this medication. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. We will work with you to find the best option. These are not all the possible side effects of SOLIRIS. Call your doctor for medical advice about side effects. Download the SOLIRIS Prescribing Information (PDF) OneSource™ Case Managers act as a bridge between you, your staff, and your patients to help support and facilitate your treatment plan. Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. 143 adults with anti-AQP4 antibody-positive NMOSD enrolled (96 received Soliris, 47 received placebo), Immunosuppressive therapies were allowed, though some people only received Soliris, The goal of the study was to determine the time to first adjudicated relapse, An adjudicated relapse means that an independent committee of medical experts confirmed that a relapse occurred, counsel you about the risk of meningococcal infection, give you information about the symptoms of meningococcal infection. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Other Systemic Infections Due to its mechanism of action, Soliris therapy should be administered with caution to patients with active We use cookies to give you the best online experience. 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. 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® and Alexion® are registered trademarks and OneSource™ is a trademark of Alexion Pharmaceuticals, Inc. Soliris® (eculizumab) Concentrated solution for intravenous infusion . Where availablelinks to product information (PI) pdf documents are provided. See full prescribing information for SOLIRIS. Soliris is only available through a restricted program called the SOLIRIS REMS (Risk Evaluation and Mitigation Strategy). SOLIRIS and other medicines can affect each other causing side effects. General information about the safe and effective use of SOLIRIS. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. It is not known if SOLIRIS will harm your unborn baby. 3065 0 obj <>stream adults and children with a disease called atypical Hemolytic Uremic Syndrome (aHUS). It is not known if SOLIRIS is safe and effective in children with gMG. h�bbd```b``q � �9Dr��HFM�f"Y_��C`g�t�^&�����@��>LځDD��?�H&Fn�]��$����� &�� More information including the full prescribing information on Soliris is available at www.soliris.net. Your doctor will decide if you need additional meningococcal vaccination. **If nursing services will be required for the therapy administration, the home health nurse will call for Whether you are newly diagnosed or have had multiple relapses, see how it may be able to help you control your NMOSD. What is the most important information I should know about SOLIRIS? 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. You can also use the TGA's MedSearch appavailable for Apple and Android devices. Your risk of meningococcal infection may continue for several weeks after your last dose of SOLIRIS. 0 SOLIRIS can lower the ability of your immune system to fight infections. Carry it with you at all times during treatment and for 3 months after your last SOLIRIS dose. 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. You can enter the product name, licence details, sponsor details, active ingredient names or the ARTG number to get results. All prescribers must be specially certified. 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. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Call your doctor for medical advice about side effects. Initial U.S. Approval: 2007 . 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. RX.PA.069.E.MPC - Soliris (Eculizumab) PAGE NUMBER: 3 of 3 Codes: J Code(s) Code Description J1300 Injection, eculizumab, 10 mg REFERENCES 1. See “How will I receive SOLIRIS?” in the Medication Guide. For more information, ask your doctor or pharmacist. See. Meningococcal vaccination is required before starting Soliris 1 Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. SOLIRIS is a prescription medicine called a monoclonal antibody. 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. Important Safety Information. If you have not been vaccinated and SOLIRIS therapy must be initiated immediately, you should also receive two weeks of antibiotics with your vaccinations. It is important to show this card to any doctor or nurse who treats you. For more information, ask your doctor or pharmacist. Below is a text only representation of the Patient Information Leaflet. SOLIRIS may also increase the risk of other types of serious infections. 1 SOLIRIS is the first and only FDA-approved drug for the treatment of NMOSD in adult patients who are anti-AQP4 antibody positive. These are not all the possible side effects of SOLIRIS. SOLIRIS and NMOSD. 4 PRESCRIBING INFORMATION Four simple steps to submit your referral. Resources for your patients on Soliris® (eculizumab). See Important Safety Information, including Boxed Warning, and full Prescribing Information. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Please see full Prescribing Information for Soliris, including Boxed WARNING regarding serious meningococcal infections. Certain people may be at risk of serious infections with gonorrhea. 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. h�b```��,�� ���� Soliris® (eculizumab) HCP | Dosing Dosing information for Soliris® (eculizumab). Fax the form to Soliris REMS at 1-877-580-2596 (ALXN); or Scan and email the form to rems@alexion.com %PDF-1.6 %���� CHOLBAM ® (cholic acid) capsules is a medicine that can help these conditions.. CHOLBAM ® is a bile acid indicated for: . Soliris is a prescription medicine called a monoclonal antibody. Soliris [prescribing information]. This information is intended for U.S. Healthcare Professionals. 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. 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). For further information call emc accessibility on 0800 198 5000. SOLIRIS increases your chance of getting serious and life-threatening meningococcal infections. 2 Patients should be immunized with meningococcal vaccines at least 2 weeks prior to receiving the first dose of Soliris. If you have an allergic reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. See full prescribing information for Soliris. These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. Use the doctor discussion guide to get the conversation started with your doctor. Sign up to get the latest news and information about anti-AQP4 antibody-positive NMOSD relapses and how Soliris can help. The text only version may be available in large print, Braille or audio CD. SOLIRIS is a medicine that affects your immune system. 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. Certain fungal infections (Aspergillus) may also happen if you take SOLIRIS and have a weak immune system or a low white blood cell count. have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. reduction in risk of relapse in adults treated with Soliris compared to placebo, were relapse-free after ~1 year vs 63% with placebo. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Please see Summary of Product Characteristics for full prescribing information for Soliris, including all … Soliris is a prescription medicine called a monoclonal antibody. If you had a meningococcal vaccine in the past, you might need additional vaccination before starting SOLIRIS. are pregnant or plan to become pregnant. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. 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 indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. Ask your doctor if you are not sure if you need to be revaccinated. 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. You are encouraged to report negative side effects of prescription drugs to the FDA. Building a community of people who know what you’re going through can be key for patients and caregivers. �x a�1X&)�.aZ�`� $�Tݠ��v���!�� H�cri��������f����!�#����e� �i��� >F&�l'/600�2�D����u�7Y�Ӣu�iO �(ʭ%�qÊ$5ǫ. All physicians who intend to prescribe Soliris must ensure they are familiar with the physician's guide to prescribing. SOLIRIS is a prescription medicine used to treat: patients with a disease called Paroxysmal Nocturnal Hemoglobinuria (PNH). SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Please see the full Prescribing Information and Medication Guide for SOLIRIS, including Boxed WARNING regarding serious and life-threatening meningococcal infections. 1,b a Starting 2 weeks after the loading dose, maintenance doses are administered once every 4 or 8 weeks (depending on body weight). Visit MedWatch, or call 1-800-FDA-1088. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Soliris safely and effectively. It is not known if SOLIRIS is safe and effective in children with NMOSD. Soliris is covered by most insurance plans. PI documents can be found by searching this website or by using the PI search database in eBusiness Services. ULTOMIRIS is the first and only long-acting complement inhibitor for atypical-HUS in adult and pediatric patients 1 month of age and older. Print and sign the Prescriber Enrollment Form Mail the form to Soliris REMS, Alexion Pharmaceuticals, 121 Seaport Boulevard, Boston, MA 02210. This site is intended for patients and caregivers. If you are a Healthcare Professional, click OK to continue; if not, click cancel to go back. Limitation of Use Tell your doctor about any side effect that bothers you or that does not go away. *Required fields.