300 mg\/3 ml\u00a0concentrate for\u00a0infusion\u00a0solution
BBN<\/p>\n\n\n\n
What <\/strong>Ultomiris is<\/strong><\/p>\n\n\n\n Ultomiris is a drug that contains the active substance ravulizumab and belongs to a drug class called monoclonal antibodies that bind to a specific target in the body. Ravulizumab has been designed to bind to the C5 complement protein, which is part of the body’s defense system known as the ‘complement system’.<\/p>\n\n\n\n What <\/strong>Ultomiris is used for<\/strong><\/p>\n\n\n\n Ultomiris is used to treat adults and children weighing 10 kg or more with a condition called\u00a0paroxysmal\u00a0nocturnal hemoglobinuria (PNH), including patients who have not been treated with complement inhibitors and patients who have received eculizumab in the past 6 months.\u00a0In patients with PNH, the complement system is overactive and attacks the red\u00a0blood cells, which can lead to low\u00a0blood cell counts\u00a0(\u00a0anemia\u00a0), fatigue, difficulty functioning, pain, abdominal pain, dark urine, shortness of breath, difficulty swallowing,\u00a0erectile dysfunction, and blood clots.\u00a0By attaching to and blocking the C5 complement protein, this drug can prevent the complement proteins from attacking the red\u00a0blood cells in the organs and can thus control the symptoms of the disease.<\/p>\n\n\n\n Ultomiris is also used to treat patients who weigh 10 kg or more with a disease affecting the blood and kidneys called atypical\u00a0hemolytic uraemic syndrome\u00a0(aHUS), including patients who have not been treated with complement inhibitors and patients who have received eculizumab for at least 3 months.\u00a0In patients with aHUS, the kidneys and blood vessels, and even the platelets, can become inflamed.\u00a0It can lead to low blood counts (too low numbers of\u00a0platelets\u00a0[lack of\u00a0platelets\u00a0] and\u00a0red blood cells[anemia]), impaired or lost kidney function, blood clots, fatigue, and general low functioning.\u00a0Ultomiris can block the body’s inflammatory reaction and its ability to attack and destroy its sensitive blood vessels, and can thus control the symptoms of the disease, e.g.\u00a0kidney damage.<\/p>\n\n\n\n Ultomiris is also used to treat adult patients with a certain type of disease that affects the muscles, called generalized\u00a0myasthenia gravis(gMG).\u00a0In patients with gMG, the muscles can be attacked and damaged by the immune system, which can lead to pronounced muscle weakness, impaired vision and mobility, shortness of breath, extreme fatigue, risk of aspiration (risk of food and drink ending up in the windpipe instead of the esophagus) and marked impairment of daily activities.\u00a0Ultomiris can block the body’s inflammatory response and its ability to attack and destroy muscles to improve muscle contraction, thereby reducing the symptoms of the disease and the impact of the disease on activities of daily living.\u00a0Ultomiris is especially intended for patients who still have symptoms, despite treatment with other medicines. Talk to your doctor before using Ultomiris.<\/p>\n\n\n\n Symptoms of infection with meningococcus and other types of Neisseria<\/em><\/strong><\/p>\n\n\n\n Because the medicine blocks the complement system, which is part of the body’s defense against\u00a0infection, using Ultomiris increases the risk that you will get a meningococcal infection caused by\u00a0Neisseria meningitides.\u00a0These are severe\u00a0infections\u00a0that affect the meninges and can spread in the blood and body (\u00a0sepsis\u00a0[blood poisoning]).<\/p>\n\n\n\n Talk to your doctor before starting Ultomiris to make sure you are vaccinated against\u00a0Neisseria meningitides<\/em>\u00a0at least 2 weeks before starting treatment.\u00a0If you cannot be vaccinated 2 weeks in advance, your doctor will\u00a0prescribe\u00a0antibiotics\u00a0to reduce the risk of\u00a0infection\u00a0until 2 weeks after the vaccination.\u00a0Make sure your current meningococcal vaccination is up to date.\u00a0You should also know that vaccination does not always prevent this type of\u00a0infection.\u00a0By national recommendations, your doctor may consider that you need additional measures to prevent\u00a0infection.<\/p>\n\n\n\n Symptoms of meningococcal infection<\/p>\n\n\n\n As it is important to quickly identify and treat meningococcal infection in patients receiving Ultomiris, you will be given a ‘patient card’ to carry with you at all times. The card states the relevant signs and symptoms of meningococcal infection\/blood poisoning.<\/p>\n\n\n\n If you experience any of the following symptoms, you must inform your doctor immediately:<\/p>\n\n\n\n Treatment for meningococcal infection during travel<\/p>\n\n\n\n If you are traveling in a region where you cannot contact your doctor or are temporarily unable to receive medical treatment, your doctor may prescribe\u00a0antibiotics\u00a0against\u00a0Neisseria meningitides<\/em>\u00a0that you can take with you.\u00a0If you get any of the symptoms described above, you must take the antibiotic course as\u00a0prescribed.\u00a0You need to remember to still see a doctor as soon as possible, even if you feel better after taking the antibiotics.<\/p>\n\n\n\n Infection you<\/strong><\/p>\n\n\n\n Before receiving Ultomiris, inform your doctor if you have any\u00a0infections.<\/p>\n\n\n\n Infusion reactions<\/strong><\/p>\n\n\n\n When Ultomiris is given, you may have infusion reactions (reactions to the drip) such as headache, low back pain, and infusion-related pain.\u00a0Some patients may experience an\u00a0allergic\u00a0or\u00a0hypersensitivity reaction\u00a0(including\u00a0anaphylaxis, a severe\u00a0allergic reaction\u00a0that causes difficulty breathing or dizziness).<\/p>\n\n\n\n Older<\/strong><\/p>\n\n\n\n No special precautions are required when treating patients 65 years of age and older, although experience with Ultomiris in elderly patients with PNH and aHUS in clinical trials is limited.<\/a><\/p>\n\n\n\n Patients under 18 years of age must be vaccinated against\u00a0Haemophilus influenza<\/em>\u00a0and pneumococcal infections.<\/p>\n\n\n\n Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.<\/p>\n\n\n\n Fertile women<\/p>\n\n\n\n The drug’s effects on an unborn child are not known. Fertile women must therefore use an effective contraceptive method during treatment and for up to 8 months after the end of treatment.<\/p>\n\n\n\n Pregnancy\/breastfeeding<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.<\/p>\n\n\n\n Ultomiris is not recommended during pregnancy or for women of childbearing potential who are not using contraception.<\/a><\/p>\n\n\n\n This medicine has no or negligible effect on the ability to drive and use machines.<\/a><\/p>\n\n\n\n After dilution with sodium chloride 9 mg\/ml (0.9%) solution for\u00a0injection, this medicinal product contains 0.18 g of\u00a0sodium\u00a0(the main component of common\/table salt) in 72 ml at the maximum\u00a0dose.\u00a0This corresponds to 9.1% of the maximum recommended daily intake of\u00a0sodium\u00a0for adults.<\/p>\n\n\n\n This should be taken into account if you have been prescribed a low-salt diet.<\/a><\/p>\n\n\n\n At least 2 weeks before you start treatment with Ultomiris, your doctor will give you a vaccine against meningococcal infections, if you have not already received this or if the vaccination is no longer protective. 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.<\/p>\n\n\n\n If your child is under 18 years of age, the doctor will vaccinate the child (if not already done) against\u00a0Haemophilus influenza<\/em>\u00a0and pneumococcal infections according to national vaccination recommendations for each age group.<\/p>\n\n\n\n Instructions for correct use<\/strong><\/p>\n\n\n\n Your doctor will calculate your\u00a0dose\u00a0of Ultomiris based on your body weight, as shown in Table 1. Your first\u00a0dose\u00a0is called\u00a0a loading\u00a0dose.\u00a0Two weeks after receiving your\u00a0loading dose, you will receive a maintenance dose of Ultomiris which is then repeated once every eight weeks for patients weighing more than 20 kg and every four weeks for patients weighing less than 20 kg.<\/p>\n\n\n\n If you have previously received another medicine for PNH or aHUS called eculizumab, the loading dose should\u00a0be\u00a0given 2 weeks after the last eculizumab\u00a0infusion.<\/p>\n\n\n\n Table 1: Weight-based dosing regimen for Ultomiris<\/strong><\/p>\n\n\n\n an<\/sup>\u00a0Only for patients with PNH and aHUS.<\/p>\n\n\n\n Ultomiris is given by infusion (drip) into a vein. Infusion one takes about 45 minutes.<\/p>\n\n\n\n If you suspect that you have received a higher dose of Ultomiris than prescribed, contact your doctor for advice.<\/a><\/p>\n\n\n\n
<\/p>\n\n\n\nWhat you need to know before you use Ultomiris<\/h2>\n\n\n\n
Do not use Ultomiris<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
Children and young people<\/h2>\n\n\n\n
Other medicines and Ultomiris<\/h2>\n\n\n\n
Pregnancy, breastfeeding, and fertility<\/h2>\n\n\n\n
Driving ability and use of machinery<\/h2>\n\n\n\n
Ultomiris contains sodium<\/h2>\n\n\n\n
How to use Ultomiris<\/h2>\n\n\n\n
Body weight range (kg)<\/strong><\/td> Loading dose (mg)<\/strong><\/td> Maintenance dose (mg)<\/strong><\/td><\/tr> 10 to less than 20 a<\/sup><\/td> 600<\/td> 600<\/td><\/tr> 20 to less than 30 a<\/sup><\/td> 900<\/td> 2,100<\/td><\/tr> 30 to less than 40 a<\/sup><\/td> 1,200<\/td> 2,700<\/td><\/tr> 40 to less than 60<\/td> 2,400<\/td> 3,000<\/td><\/tr> 60 to less than 100<\/td> 2,700<\/td> 3,300<\/td><\/tr> 100 or more<\/td> 3,000<\/td> 3,600<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n If you have been given too much Ultomiris<\/h2>\n\n\n\n
If you forget a visit where you were supposed to get Ultomiris<\/h2>\n\n\n\n