This medicine contains sodium (see section 2 âUltomiris contains sodiumâ). Whether you or a child you care for had a recent atypical-HUS diagnosis, or you’ve been part of the atypical-HUS community for years, now could be the right time to WIDEN YOUR WORLD. 2019;10(40):1-12. INDICATIONS . 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. 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. I. 3 Furzeground Way, Stockley Park, Uxbridge, Middlesex, UB111EZ, UK. Ask your doctor if you are not sure if you need to be revaccinated. Kobayashi RH, Gupta S, Melamed I, et al. In patients with aHUS, their kidneys and blood vessels, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning. Alexion®, ULTOMIRIS®, and Soliris® are registered trademarks and OneSource is a trademark of Alexion Pharmaceuticals, Inc. Your doctor will give you a Patient Safety Card about the risk of meningococcal infection. What Ultomiris looks like and contents of the pack. What you need to know before you use Ultomiris
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. If you were previously receiving another medicine for PNH and aHUS called eculizumab, the loading dose should be given 2 weeks after the last eculizumab infusion. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. To bookmark a medicine you must sign up and log in. Interrupting or ending treatment with Ultomiris may cause your aHUS symptoms to come back. These measures will help protect the environment. You should also be aware that vaccination may not always prevent this type of infection. This medicinal product is subject to additional monitoring. To email a medicine you must sign up and log in. It is written for patients and gives information about taking or using a medicine. FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE SKYRIZI®is indicated for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The infusion will take approximately 2 hours. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections.. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening … This includes any possible side effects not listed in this leaflet. The text only version may be available in large print, Braille or audio CD. Before starting Ultomiris, inform your doctor if you have any infections. Keep this leaflet. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections that may quickly become life-threatening and cause death if not recognized and treated early. Below is a text only representation of the Patient Information Leaflet. Accessed October 2020. Cheshire, CT: Alexion Pharmaceuticals, Inc.; October 2017. If you forget an appointment, please contact your doctor immediately for advice and see section below âIf you stop using Ultomirisâ. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. Read all of this leaflet carefully before you start using this medicine because it contains important information for you. ULTOMIRIS is not used in treating people with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Do not pass it on to others. 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)]. An increase in your lactate dehydrogenase (LDH) levels, a laboratory marker of destruction of red blood cells. How to store Ultomiris
It is not known if ULTOMIRIS is safe and effective in children younger than 1 month of age. What Ultomiris is and what it is used for
Carry it with you at all times during treatment and for 8 months after your last ULTOMIRIS dose. References 1. ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Ultomiris 300 mg/30 mL concentrate for solution for infusion. or search for MHRA Yellow Card in the Google Play or Apple App Store. Front Immunol. Meningococcal vaccines reduce but do not prevent all meningococcal infections. SOLIRIS® (eculizumab) [package insert]. 2. 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. Call your doctor right away if you have any new signs or symptoms of infection. 6. 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. If you are not sure what the side effects below are, ask your doctor to explain them to you. Each vial of solution contains 300 mg of ravulizumab. 2011; 21-29. Continue typing to refine. 2. ULTOMIRIS is a drug used to treat adults with a disease called paroxysmal nocturnal hemoglobinuria (PNH).PNH is a rare, life-threatening disease in which the bone marrow does not produce enough blood cells and red blood cells break apart prematurely (called hemolysis). Before beginning Ultomiris ™, a baseline serum creatine, LDH, and platelet count are necessary for diagnosis and monitoring throughout therapy. Find support and connect with the atypical-HUS community. 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. Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines. The expiry date refers to the last day of that month. The maintenance dose is 2700mg, starting 2 weeks after loading dose administration. RECENT MAJOR CHANGES _____ Indications and Usage 10/2019 Dosing and Administration (2.3, 2.4) 10/2019 Contraindications 10/2019 2 We may cover Soliris®** (eculizumab) OR we may cover Ultomiris®** (ravulizumab) when all of the following criteria are met: 1. Alexion Pharmaceuticals; 2009. For further information call emc accessibility on 0800 198 5000. Use aseptic technique to prepare ULTOMIRIS as follows: 1. 2. Management of paroxysmal nocturnal hemoglobulinuria in the era of complement inhibitory therapy. What you need to know before you use Ultomiris. Once diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, this medicine contains 2.65 g sodium (main component of cooking/table salt) in 720 mL at the maximal dose. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FEMARA safely and effectively. If you have not been vaccinated and ULTOMIRIS therapy must be initiated immediately, you should also receive 2 weeks of antibiotics with your vaccinations. 6. Ultomiris injection is used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults. Soliris (eculizumab) [package insert]. Hematology. If you have any further questions, ask your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed below. ULTOMIRIS increases your chance of getting serious and life-threatening meningococcal infections. The effects of the medicine on an unborn child are not known. If you cannot be vaccinated at least 2 weeks before you start treatment with Ultomiris, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. â¼This medicine is subject to additional monitoring. Package leaflet: Information for the user. If you experience any of the following symptoms, you should immediately inform your doctor: Treatment for meningococcal infection while travelling. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use SOLIRIS safely and effectively. If your child is less than 18 years, your doctor will administer a vaccine (if not yet done) against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group. The maintenance dose is 3000mg, starting 2 weeks after loading dose administration. Ravulizumab (ALXN1210) vs eculizumab in adult patients with 49 (Issue 1270), September 24, 2007. Ultomiris [package insert]. Do not use this medicine after the expiry date which is stated on the carton after âEXPâ. These are severe infections affecting the linings of the brain and can spread throughout the blood and body (sepsis). Your first dose is called the loading dose. 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEGSEDI® safely and effectively. Prior authorization is required to ensure the safe, clinically appropriate and cost effective use of Ultomiris while maintaining optimal therapeutic outcomes. Under the ULTOMIRIS REMS, prescribers must enroll in the program (5.1). Your doctor will decide if you need additional vaccination. If your doctor decided that urgent treatment with ULTOMIRIS is needed, you should receive meningococcal vaccination as soon as possible. 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. Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the bodyâs defence system called the âcomplement systemâ. 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). Before you receive ULTOMIRIS, tell your doctor about all of your medical conditions, including if you: have an infection or fever, are pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. HCPs who prescribe ULTOMIRIS must be specifically certified. The other ingredients are: sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate, sodium chloride, polysorbate 80, water for injections. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements which could affect your treatment. When Ultomiris is given, you may experience reactions to the infusion (drip) such as headache, lower back pain, and infusion-related pain. Get complimentary, personalized support from a dedicated team with expertise in health insurance, advanced training in atypical-HUS, and information about atypical-HUS community resources. ULTOMIRIS (ravulizumab-cwvz) injection 10 mg/mL is translucent, slight whitish color solution supplied in single-dose vials as: • 300 mg/30 mL (10 mg/mL) carton containing one vial: NDC 25682-022-01 Store ULTOMIRIS vials refrigerated at 2°C - 8°C (36°F - 46°F) in the original carton to protect from light. Ensure that your current meningococcal vaccination is up to date. 2. Call your doctor right away if you miss an ULTOMIRIS infusion or for medical advice about side effects. For individuals with body weight greater than 100kg the loading dose is 3000mg. ULTOMIRIS is the first and only long-acting C5 inhibitor that provides immediate and complete inhibition for 8 weeks. Talk to your doctor before using Ultomiris. • Lee JW, Sicre de Fontbrune F, Wong LL, et al. FDA-Approved Indication Store in the original package in order to protect from light. 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 … 2. Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception. For individuals with body weight 20 to <30kg the loading dose is 900mg. ULTOMIRIS (ravulizumab) POLICY . Do Contents of the pack and other information, 1. What Ultomiris is and what it is used for. You may report side effects to FDA at 1-800-FDA-1088. To view the changes to a medicine you must sign up and log in. This website is intended for residents of the United States. Keep this medicine out of the sight and reach of children. 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. 18 years of age or older b. Documented baseline value for serum lactate dehydrogenase (LDH) is ≥1.5 times the upper PNH is a rare genetic disorder in which defective red blood cells break down prematurely and leak hemoglobin into your blood. You can help by reporting any side effects you may get. in the complement cascade that is essential for the formation of the membrane attack complex. Accessed October 2019. 5. responsible for cell lysis. You can help by reporting any side effects you may get. This will allow quick identification of new safety information. See the end of section 4 for how to report side effects. Ultomiris is used to treat adult patients with a disease called paroxysmal nocturnal haemoglobinuria (PNH), including patients untreated with complement inhibitor and patients who have received eculizumab for at least the past 6 months. FULL PRESCRIBING INFORMATION . Ravulizumab is a complement inhibitor Food and Drug Administration (FDA) Boston, MA; Alexion Pharmaceuticals, Inc; October 2020. References 1. Management of paroxysmal nocturnal hemoglobulinuria in the era of complement inhibitory therapy. This will allow quick identification of new safety information. 2011; 21-29. Parker CJ. See full prescribing information for ALDURAZYME. See section 4. A significant fall in your platelets (thrombocytopenia). Start typing to retrieve search suggestions. You should not breastfeed during treatment and for 8 months after your final dose of ULTOMIRIS. If you receive more Ultomiris than you should. You should take this into consideration if you are on a controlled sodium diet. Your doctor will discuss the possible side effects with you and explain the risks. For individuals with body weight 40 to <60kg the loading dose is 2400mg. 15. Ultomiris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) (1). 3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 MRD-positive B-cell Precursor ALL BLINCYTO is indicated for the treatment of … 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. aNot used in treating people with STEC-HUS. 1. It is important to show this card to any doctor or nurse to help them diagnose and treat you quickly. 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. Package leaflet: Information for the user, Ultomiris 300 mg/30 mL concentrate for solution for infusion. • Ultomiris [package insert]. If you forget an appointment to receive Ultomiris. See full prescribing information for Adverse events should also be reported to Alexion Pharma UK Ltd on [email protected], Freephone (UK): 0800321 3902. This site uses cookies. Ultomiris is also used to treat patients 10 kg and over with a disease affecting the blood system and kidney called atypical haemolytic uremic syndrome (aHUS), including patients untreated with complement inhibitor and patients who have received eculizumab for at least 3 months. ULTOMIRIS is a medicine that affects your immune system and can lower the ability of your immune system to fight infections. Ultomiris [package insert]. The product code(s) for this leaflet are: EU/1/19/1371/001, EU/1/19/1371/002, EU/1/19/1371/003. For individuals with body weight 60 to <100kg the loading dose is 2700mg. 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). The maintenance dose is 3300mg, starting 2 weeks after loading dose administration. Your doctor will want to monitor you closely for at least 16 weeks. 3. Ultomiris [package insert]. The dosing for this With ULTOMIRIS, you can experience the freedom of up to 8 weeks between infusionsa, with the comfort of established safety. At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections if you have not previously had one or if your vaccination is outdated. … Paroxysmal nocturnal hemoglobinuria (PNH) a. This is equivalent to 133 % of the recommended maximum daily dietary intake of sodium for an adult. In patients with PNH, the complement system is overactive and attacks their red blood cells, which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing, erectile dysfunction and blood clots. By reporting side effects, you can help provide more information on the safety of this medicine. Boston, MA: Alexion Pharmaceuticals, Inc.; October 2019. A significant rise in destruction of your red blood cells. Copyright © 2020 Alexion Pharmaceuticals, Inc. All rights reserved. Boston, MA; Alexion Pharmaceuticals, Inc; October 2019. Clinical efficacy, safety and tolerability of a new subcutaneous immunoglobulin 16.5% (Octanorm [Cutaquig ®]) in the treatment of patients with primary immunodeficiencies. If you have aHUS, your doctor will need to monitor you closely for at least 12 months after stopping treatment for signs of worsening aHUS or problems related to a type of abnormal clotting and breakdown of your red blood cells called thrombotic microangiopathy (TMA). The maintenance dose is 600mg, starting 2 weeks after loading dose administration. Ultomiris is given by infusion (drip) into a vein. ravulizumab This medicine is subject to additional monitoring. You must receive meningococcal vaccines at least 2 weeks before your first dose of ULTOMIRIS if you are not vaccinated. If you cannot be vaccinated 2 weeks beforehand, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated. Very common (may affect more than 1 in 10 people): Common (may affect up to 1 in 10 people): Uncommon (may affect up to 1 in 100 people): If you get any side effects, talk to your doctor, pharmacist or nurse. 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. Ultomiris is a clear to translucent, slight whitish colour, practically free from particles solution. 1. If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor. A significant fall in your red blood cell counts (anaemia). Ultomiris is presented as a concentrate for solution for infusion (30 mL in a vial â pack size of 1). Decreased urination (problems with your kidneys). Eligible patients may pay as little as $0 in out-of-pocket costs relating to medication and infusions. ULTOMIRIS can lower the ability of your immune system to fight infections. Borowitz MJ, Craig FE, DiGiuseppe JA, Illingworth AJ, Rosse W, Sutherland DR, Wittwer CT, Richards SJ. Ultomiris [package insert]. When suggestions are available use up and down arrows to review and ENTER to select. ULTOMIRIS is only available through a program called the ULTOMIRIS REMS.