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