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Symptoms or problems that can happen due to red blood cell Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). It is important to show this card to any doctor or nurse who treats you. Under the Soliris REMS, prescribers must enroll in the program. Physicians, Prescribing If you have an infusion-related reaction to SOLIRIS, your doctor may need to infuse SOLIRIS more slowly, or stop SOLIRIS. meningococcal vaccine. 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. Ask your doctor if you are not sure if you need to be revaccinated, give you information about the symptoms of meningococcal infection. 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. Certain people may be at risk of serious infections with gonorrhea. If you are a prescriber or infusion center that would like to be See Important Safety Information, including Boxed Warning, and full Prescribing Information. 888-765-4747 for support. SOLIRIS include: For questions concerning the technical and a drop in your platelet count. And, when the … These are life-threatening genetic diseases that cause the breakdown of red blood cells resulting in various medical complications. Before you can receive SOLIRIS, your doctor must enroll in Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. Soliris is a treatment that is given by intravenous (IV) infusion. Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain, trouble breathing or … Plans of Treatment. https://policies.google.com/privacy?hl=en, counsel you about the risk of meningococcal infection, give you information about the symptoms of meningococcal Tell your doctor or nurse right away if you experience any of these symptoms during your Soliris infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; or if you feel faint or pass out. See Important Safety Information, including Boxed Warning, and full Prescribing Information. Eculizumab (Soliris®) On June 27, 2019, The U.S. Food and Drug Administration approved Eculizumab (Soliris®) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive. The most common side effects in people with PNH treated with Outcomes measured included age- and sex-matched survival rates, transfusion requirements, thrombotic event rates, and platelet counts. If an adverse event occurs during the administration of Soliris, the infusion may be slowed or stopped at the discretion of the physician. or throat, and feel faint or pass out. SOLIRIS is a medicine that affects your immune system. after your last SOLIRIS dose. SOLIRIS include: Soliris® Enrollment Form Fax Referral To: 1-800- 323 -2445 Phone: 1 -800 -237- 2767 Email Referral To: customerservicefax@caremark.com ... Hospital/Clinic CVS Specialty to coordinate skilled nursing to provide home infusion or medication via gravity per home care protocols and provide IV/port access care, flushing per protocol Other . You and your healthcare professional should Soliris: Infusion Therapy for aHUS Living with a chronic health condition is not only uncomfortable and frustrating, but it can also take a toll on your emotional wellbeing and quality of life. Infusion therapy involves inserting an IV line into a vein in your arm to administer the medicine. See “How will I receive SOLIRIS?” in the Medication Guide. adults with a disease called neuromyelitis optica spectrum including prescription and over-the-counter medicines, vitamins, your nose or throat (nasopharyngitis), diarrhea, back pain, have not been vaccinated against meningitis infection unless your doctor decides that urgent treatment with SOLIRIS is needed. For more information, ask your doctor or pharmacist. does not go away. SOLIRIS is not for use in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). medical conditions, including if you: 1 Tell your doctor about any side effect that bothers you or that does not go away. It is You are now leaving SolirisInfusionFinder.com, a website provided by Alexion Pharmaceuticals, Inc. If the infusion is slowed, the total infusion time may not exceed two hours. SOLIRIS may also increase the risk of other types of serious (nasopharyngitis), back pain, and nausea. Terms and Conditions, For vaccinations during treatment with SOLIRIS. If you have an allergic reaction to Soliris, your doctor may need to slow or stop the infusion. with PNH, gMG, or NMOSD. include: stroke, confusion, seizure, chest pain (angina), your search area or call OneSource™ at Visit MedWatch, or call 1-800-FDA-1088. By using this function, you will be leveraging a different site, in which this Privacy Notice does not apply. medicines you take, You are encouraged to report negative side effects of prescription drugs to the FDA. SOLIRIS may also increase the risk of other types of serious infections. SOLIRIS can cause serious side effects including serious allergic reactions. needed, you should receive meningococcal vaccination as soon To Provide You Infusion Sites in Your Search Area: The Site provides access to a locator tool, which shows sites providing infusion services. (contusion). are breastfeeding or plan to breastfeed. breathing or shortness of breath, swelling of your face, tongue, before your first dose of SOLIRIS if you are not vaccinated. symptoms during your SOLIRIS infusion: chest pain, trouble Your doctor will decide if you need people with Shiga toxin E. coli related hemolytic uremic Initial phase: 600 mg of eculizumab via a 25 – 45 minute intravenous infusion every week for the first 4 weeks (weeks 1-4). Soliris is a complement inhibitor used to reduce hemolysis in patients with PNH, inhibit complement-mediated thrombotic microangiopathy in patients with aHUS and reduce the activity of complement at the muscle surface in patients with anti-AchR+ gMG. Meningococcal infections may quickly become life-threatening and cause death if not recognized and treated early. SOLIRIS can lower the ability of your immune system to fight infections. Essential Health Benefits for Individual and Small Group For plan … administering infusions. Soliris must be administered by a healthcare professional and under the supervision of a physician experienced in the management of patients with haematological, renal, neuromuscular or neuro-inflammatory disorders. Visit MedWatch, or call 1-800-FDA-1088. have not been vaccinated against meningitis infection unless The enabling program we utilize, provided by Google Maps, does leverage analytic tools, which include features that store and track features consistent with their privacy policy, which can be found here: https://policies.google.com/privacy?hl=en. If you had a meningococcal vaccine in the past, you might need Is this a 1. st. dose? disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody Your doctor will give you a Patient Safety Card about the risk Know the medications you take and the vaccines you receive. • Transfer the recommended dose to an infusion bag. cold (upper respiratory infection), stomach-area (abdominal) adults with a disease called generalized myasthenia gravis By providing my information above, I am giving Alexion and companies working with Alexion permission to contact me by mail, email, telephone, or text message for communications or marketing purposes to provide me with information about Alexion’s products, services, and programs or other topics of interest; conduct market research; or ask me about my experience with or thoughts about such topics. medical care right away if you get any of these signs and Dilute Soliris to a final admixture concentration of 5 mg/mL using the following steps: • Withdraw the required amount of Soliris from the vial into a sterile syringe. encouraged to report negative side effects of prescription drugs patients with a disease called Paroxysmal Nocturnal • Maintenance phase: 900 mg of Soliris administered via a 25 – 45 minute (35 minutes ± 10 minutes) Tell your doctor about any side effect that bothers you or that as possible. Meningococcal vaccines reduce the risk of meningococcal infection but do not prevent all meningococcal infections. Meningococcal vaccines reduce but do not prevent all Home Infusion; Patient Center. See. It is not Tell your doctor or nurse right away if you get any of these symptoms during your SOLIRIS infusion: chest pain; trouble breathing or shortness of breath; swelling of your face, tongue, or throat; and feel faint or pass out. Your doctor will perform a blood test to make sure Soliris is the right treatment for your condition. Soliris® (eculizumab) Home | HCP Site 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). Refer to Oxford’s Home Health Care policy. Please see the accompanying full US/SOL-a/0125 11/20, Contact Us antibiotics with your vaccinations. SOLIRIS is a medicine that affects your immune system. This is followed by 900 mg of eculizumab for the fifth week of the initial phase. By using our website, you agree to our use of cookies in accordance with our. If you have not been vaccinated and SOLIRIS therapy must be Home infusion of Soliris and Ultomiris requires additional prior authorization for the home care services. Requests for home infusion of Soliris require additional pre-certification for the home care services. Talk to your doctor about whether you are at risk for gonorrhea infection, about gonorrhea prevention, and regular testing. Do not receive SOLIRIS if you have a meningococcal infection or 4- Special Handling and Storage Soliris vials must be stored in the original carton until time of use under refrigerated conditions at 2-8ºC and protected from light. SOLIRIS is a prescription medicine used to treat: It is not known if SOLIRIS is safe and effective in children Feel the freedom that comes from getting the treatment you need without going into the doctor’s office. SOLIRIS REMS. to any doctor or nurse to help them diagnose and treat you meningococcal infection; give you information and a (gMG) who are anti-acetylcholine receptor (AChR) antibody In the UK, Leeds Teaching Hospitals with Healthcare at Home have developed a home infusion programme that ensures safe administration of eculizumab in the patient’s home at a time … Soliris is a medicine used to treat adults and children with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS). Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Yes No Please see Privacy Notice.
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Geschrieben am Februar 20th, 2021