Ultomiris [package insert]. Soliris (eculizumab) [package insert]. What you need to know before you use Ultomiris. For further information call emc accessibility on 0800 198 5000. Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial â pack size of 1). This medicinal product is subject to additional monitoring. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FEMARA safely and effectively. 4. Now FDA approved 100 mg/mL formulation: get the details, IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING. or search for MHRA Yellow Card in the Google Play or Apple App Store. 6. The most common side effects of ULTOMIRIS in people with aHUS are upper respiratory infection, diarrhea, nausea, vomiting, headache, high blood pressure and fever. The effects of the medicine on an unborn child are not known. This medicine has been prescribed for you only. Hematology. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). ravulizumab This medicine is subject to additional monitoring. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. Decreased urination (problems with your kidneys). If you had a meningococcal vaccine in the past, you might need additional vaccination. You may need to read it again. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS. Do You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated. See full prescribing information for Ultomiris 300 mg/3 mL single-use vials for injection: 25682-0025-xx Ultomiris 300 mg/30 mL single-use vials for injection: 25682-0022-xx Ultomiris 1100 mg/11 mL single-use vials for injection: 25682-0028-xx VII. The text only version may be available in large print, Braille or audio CD. See the end of section 4 for how to report side effects. Continue typing to refine. … This will allow quick identification of new safety information. ULTOMIRIS can cause serious side effects including infusion-related reactions. Making sure you have all the tools you need to understand and manage your atypical-HUS can really help during your journey. Boston, MA; Alexion Pharmaceuticals, Inc; October 2020. Accessed October 2020. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. Yutiq™ (fluocinolone acetonide intravitreal implant) 0.18 mg is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SOLIRIS safely and effectively. References 1. You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken the antibiotics. The expiry date refers to the last day of that month. Do not receive ULTOMIRIS if you have a meningococcal infection or have not been vaccinated against meningococcal infection unless your doctor decides that urgent treatment with ULTOMIRIS is needed. For individuals with body weight 30 to <40kg the loading dose is 1200mg. ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). You can help by reporting any side effects you may get. 2. Accessed October 2020. Boston, MA: Alexion Pharmaceuticals, Inc.; December 2018. Boston, MA: Alexion Pharmaceuticals, Inc.; October 2019. References 1. Tell your doctor about any side effect that bothers you or that does not go away. The number of vials to be diluted is determined based on the individual patient’s weight and the prescribed dose [see Dosage and Administration (2.2)]. 3 . HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ALDURAZYME safely and effectively. Make sure your child receives vaccinations against Streptococcus pneumoniae and Haemophilis influenzae type b (Hib) if treated with ULTOMIRIS. See section 4. 2. Continue, Alexion Pharma International Operations Unlimited Company. SOLIRIS® is the First and Only Approved Therapy for PNH 2 SOLIRIS® (eculizumab) Humanized First in Class Anti - C5 Antibody Hinge 3 2 Human IgG 4 Heavy Chain Constant Regions 2 and 3 (Eliminates complement activation) Complementarity Determining Regions Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. Ultomiris, a long-acting complement inhibitor, works by specifically binding to the complement protein C5, inhibiting its cleavage to C5a and C5b, thereby preventing the … Adverse events should also be reported to Alexion Pharma UK Ltd on [email protected], Freephone (UK): 0800321 3902. If you have not been vaccinated against meningococcal infection. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. Management of paroxysmal nocturnal hemoglobulinuria in the era of complement inhibitory therapy. 2019;10(40):1-12. For individuals with body weight 40 to <60kg the loading dose is 2400mg. The original leaflet can be viewed using the link above. Your doctor will discuss the possible side effects with you and explain the risks. You may report side effects to FDA at 1-800-FDA-1088. Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. Use aseptic technique to prepare ULTOMIRIS as follows: 1. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Keep this medicine out of the sight and reach of children. Call your doctor or get emergency medical care right away if you get any of these signs and symptoms of a meningococcal infection: headache with nausea or vomiting, headache and fever, headache with a stiff neck or stiff back, fever, fever and a rash, confusion, muscle aches with flu-like symptoms and eyes sensitive to light. The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. To bookmark a medicine you must sign up and log in. It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. FDA-Approved Indication Package leaflet: Information for the user, Ultomiris 300 mg/30 mL concentrate for solution for infusion. For individuals with body weight 10 to <20kg the loading dose is 600mg. This website is intended for residents of the United States. Ultomiris [package insert]. The infusion will take approximately 2 hours. 5. To email a medicine you must sign up and log in. Be the first to get updates about ULTOMIRIS and special patient-focused resources, including webinars featuring leading atypical-HUS experts. RECENT MAJOR CHANGES _____ Indications and Usage 10/2019 Dosing and Administration (2.3, 2.4) 10/2019 Contraindications 10/2019 See full prescribing information for Interrupting or ending treatment with Ultomiris may cause your aHUS symptoms to come back. Symptoms or problems that can happen with TMA may include: confusion or loss of consciousness, seizures, chest pain (angina), difficulty breathing and blood clots or stroke. The dosing for this With ULTOMIRIS, you can experience the freedom of up to 8 weeks between infusionsa, with the comfort of established safety. The maintenance dose is 2700mg, starting 2 weeks after loading dose administration. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/. 2. It is not known if ULTOMIRIS will harm your unborn baby or if it passes into your breast milk. ULTOMIRIS is a prescription medicine used to treat adults and children 1 month of age and older with a disease called atypical Hemolytic Uremic Syndrome (aHUS). Contents of the pack and other information. An increase in your serum creatinine level (problems with your kidneys), Abdominal pain, vomiting, stomach discomfort after meals (dyspepsia), Back pain, joint pain (arthralgia), muscle pain (myalgia) and muscle spasms, Influenza like illness, feeling tired (asthenia). Parker CJ. These measures will help protect the environment. This will allow quick identification of new safety information. Two weeks after receiving your loading dose, you will be given a maintenance dose of Ultomiris, and this will then be repeated once every 8 weeks for patient above 20 kg and every 4 weeks for patient less than 20 kg. Ultomiris 300 mg/30 mL concentrate for solution for infusion. References 1. Possible side effects Before you can receive ULTOMIRIS, your doctor must: enroll in the ULTOMIRIS REMS program; counsel you about the risk of meningococcal infection; give you information and a Patient Safety Card about the symptoms and your risk of meningococcal infection (as discussed above); and make sure that you are vaccinated with a meningococcal vaccine, and if needed, get revaccinated with the meningococcal vaccine. By reporting side effects, you can help provide more information on the safety of this medicine. The risks of stopping Ultomiris include an increase in small blood vessel damage, which may cause: If you have any further questions on the use of this medicine, ask your doctor. ULTOMIRIS can lower the ability of your immune system to fight infections. 1. This medicine contains sodium (see section 2 âUltomiris contains sodiumâ). Ultomiris [package insert]. This includes any possible side effects not listed in this leaflet. Table 1: Ultomiris weight-based dosing regimen. More time between infusions means…I get to actually be home more for homeschooling my 12-year-old. This will allow quick identification of new safety information. Ultomiris ™ was approved by the FDA in 2019 for the treatment of atypical hemolytic uremic syndrome (aHUS) in pediatric patients over one month of age and adult patients. Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 3. Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception. When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain. aTwo weeks after the starting dose, ULTOMIRIS is infused every 8 weeks for adults and every 4 or 8 weeks for pediatric patients (depending on body weight). Tell your doctor about all the vaccines you receive and medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. The maintenance dose is 3300mg, starting 2 weeks after loading dose administration. For individuals with body weight 60 to <100kg the loading dose is 2700mg. Do not use this medicine after the expiry date which is stated on the carton after âEXPâ. responsible for cell lysis. Lee JW, Sicre de Fontbrune F, Wong LL, et al. 49 (Issue 1270), September 24, 2007. Your doctor will decide if you need additional vaccination. ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). After dilution with sodium chloride 9 mg/mL (0.9 %) solution for injection, the medicine should be used immediately, or within 24 hours if refrigerated or within 6 hours at room temperature. Boston, MA; Alexion Pharmaceuticals, Inc; October 2019. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. Alexion Pharmaceuticals; 2009. Package leaflet: Information for the user. ULTOMIRIS requires dilution to a final concentration of 5 mg/mL. Call your doctor right away if you have any new signs or symptoms of infection. Hematology. Because the medicine blocks the complement system, which is part of the bodyâs defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis. Ask your pharmacist how to throw away medicines you no longer use. 2 We may cover Soliris®** (eculizumab) OR we may cover Ultomiris®** (ravulizumab) when all of the following criteria are met: 1. If you are not sure what the side effects below are, ask your doctor to explain them to you.
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