InfoCons Consumer Protection informs you – Ultomiris – Package Leaflet
Ultomiris – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Ultomiris, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Ultomiris is and what it is used for
What is Ultomiris Ultomiris is a medicine that contains the active substance ravulizumab and it belongs to a class of medicines called monoclonal antibodies, that attach to a specific target in the body. Ravulizumab has been designed to attach to the C5 complement protein, which is a part of the body’s defence system called the ‘complement system’.
What is Ultomiris used for Ultomiris is used to treat adult and children patients 10 kg and over 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. 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 swal lowing, erectile dysfunction and blood clots. By attaching to and blocking the C5 complement protein, this medicine can stop complement proteins from attacking red blood cells and so control symptoms of the disease.
Ultomiris is also used to treat adult and children 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.
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. U ltomiris can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable blood vessels and so control symptoms of the disease including injury to the kidneys.
Ultomiris is also used to treat adult patients with a certain type of disease affecting the muscles called generalised Myasthenia Gravis (gMG). In patients with gMG, their muscles can be attacked and damaged by the immune system which can lead to profound muscle weakness, impaired vision and mobility, shortness of breath, extreme fatigue, risk for aspiration, and markedly impaired activities of daily living. Ultomiris can block the body’s inflammatory response, and its ability to attack and destroy 56 its own muscles to improve muscle contraction, thereby reducing symptoms of the disease and impact of the disease on the activities of daily living. Ultomiris is specifically indicated for patients who remain symptomatic despite treatment with other therap ies.
Ultomiris is also used to treat adult patients with a disease of the central nervous system that mainly affects the optic (eye) nerves and the spinal cord called Neuromyelitis Optica Spectrum Disorder (NMOSD). In patients with NMOSD, the optic nerves and spinal cord are attacked and damaged by the immune system working incorrectly, which can lead to loss of sight in one or both eyes, weakness or loss of movement in the legs or arms, painful spasms, loss of feeling, problems with bladder and bowel function a nd marked difficulties with activities of daily living. Ultomiris can block the body’s abnormal immune response, and its ability to attack and destroy its own optic nerves and spinal cord, which reduces the risk of a relapse or attack of NMOSD.
⚠️ 2. What you need to know before you use Ultomiris
Do not use Ultomiris
- If you are allergic to ravulizumab or any of the other ingredients of this medicine (listed in section 6).
- If you have not been vaccinated against meningococcal infection.
- If you have meningococcal infection.
Warnings and precautions
Talk to your doctor before using Ultomiris.
Meningococcal and other Neisseria infections symptoms Because the medicine blocks the complement system, which is part of the body’s defences against infection, the use of Ultomiris increases your risk of meningococcal infection caused by Neisseria meningitidis . These are severe infections affecting the linings of the brain which can cause inflammation of the brain (encephalitis) and can spread throughout the blood and body (sepsis).
Consult your doctor before you start Ultomiris to be sure that you receive vaccination against Neisseria meningitidis at least 2 weeks before beginning therapy. 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. Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not always prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Meningococcal infection symptoms Because of the importance of rapidly identifying and treating meningococcal infection in patients who receive Ultomiris, you will be provided a ‘Patient card’ to carry with you at all times, listing relevant signs and symptoms of meningococcal infection/se psis/encephalitis.
If you experience any of the following symptoms, you should immediately inform your doctor:
- headache with nausea or vomiting
- headache and fever
- headache with a stiff neck or stiff back
- fever
- fever and rash
- confusion
- muscle aches with flu -like symptoms
- eyes sensitive to light Treatment for meningococcal infection while travelling 57 If you are travelling in a region where you are unable to contact your doctor or will be temporarily unable to receive medical treatment, your doctor may prescribe an antibiotic against Neisseria meningitidis to bring with you. If you experience any of the symptoms described above, you should take the course of antibiotics as prescribed. You should bear in mind that you should still see a doctor as soon as possible, even if you feel better after having taken t he antibiotics.
Infections Before starting Ultomiris, inform your doctor if you have any infections.
Infusion-related reactions When Ultomiris is given, you may experience reactions to the infusion (drip) (infusion reaction) such as headache, lower back pain, and infusion -related pain. Some patients may experience allergic or hypersensitivity reactions (including anaphylaxis, a serious allergic reaction which causes difficulty breathing or dizziness).
Children and adolescents
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections.
Elderly There are no special precautions needed for the treatment of patients aged from 65 years and over, although experience with Ultomiris in elderly patients with PNH, aHUS, or NMOSD in clinical studies is limited.
Other medicines and Ultomiris
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
Pregnancy, breast -feeding, and fertility Women of childbearing potential The effects of the medicine on an unborn child are not known. Therefore, effective contraception during treatment and for 8 months after treatment should be used in women who are able to get pregnant.
Pregnancy/ Breast -feeding If you are pregnant or breast -feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Ultomiris is not recommended during pregnancy and in women of childbearing potential not using contraception.
Driving and using machines
This medicine has no or negligible influence on the ability to drive and use machines.
Ultomiris contains sodium
Once diluted with sodium chloride 9 mg/mL (0.9%) solution for injection, this medicine contains 0.18 g sodium (main component of cooking/table salt) in 72 mL at the maximal dose. This is equivalent to 9.1 % of the recommended maximum daily dietary intake of sodium for an adult.
You should take this into consideration if you are on a controlled sodium diet.
Ultomiris contains polysorbate
This medicine contains 1.5 mg of polysorbate 80 in each vial which is equivalent to 0.53 mg/kg. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.
💊 3. How to use Ultomiris
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. 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.
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.
Instructions for proper use Your dose of Ultomiris will be calculated by your doctor, based on your body weight, as shown in Table 1. Your first dose is called the loading dose. 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.
If you were previously receiving another medicine for PNH, aHUS, gMG, or NMOSD called eculizumab, the loading dose should be given 2 weeks after the last eculizumab infusion.
Table 1: Ultomiris weight -based dosing regimen Body weight range (kg) Loading dose (mg) Maintenance dose (mg) 10 to less than 20a 600 600 20 to less than 30a 900 2,100 30 to less than 40a 1,200 2,700 40 to less than 60 2,400 3,000 60 to less than 100 2,700 3,300 above 100 3,000 3,600 a For patients with PNH and aHUS only.
Ultomiris is given by infusion (drip) into a vein. The infusion will take approximately 45 minutes.
If you receive more Ultomiris than you should If you suspect that you have been accidentally given a higher dose of Ultomiris than prescribed, please contact your doctor for advice.
If you forget an appointment to receive Ultomiris If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using Ultomiris”.
If you stop using Ultomiris for PNH
Interrupting or ending treatment with Ultomiris may cause your PNH symptoms to return with greater severity. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely for at least 16 weeks.
The risks of stopping Ultomiris include an increase in the destruction of your red blood cells, which may cause:
- An increase in your lactate dehydrogenase (LDH) levels, a laboratory marker of destruction of red blood cells,
- A significant fall in your red blood cell counts (anaemia),
- Dark urine,
- Fatigue,
- Abdominal pain,
- Shortness of breath,
- Difficulty swallowing,
- Erectile dysfunction (impotence),
- Confusion or change in how alert you are,
- Chest pain, or angina,
- An increase in your serum creatinine level (problems with your kidneys), or 59 • Thrombosis (blood clotting).
If you have any of these symptoms, contact your doctor.
If you stop using Ultomiris for aHUS
Interrupting or ending treatment with Ultomiris may cause your aHUS symptoms to come back. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely.
The risks of stopping Ultomiris include an increase in small blood vessel damage, which may cause:
- A significant fall in your platelets (thrombocytopenia),
- A significant rise in destruction of your red blood cells,
- An increase in your lactate dehydrogenase (LDH) levels, a laboratory marker of destruction of red blood cells,
- Decreased urination (problems with your kidneys),
- An increase in your serum creatinine level (problems with your kidneys),
- Confusion or change in how alert you are,
- Change in your vision
- Chest pain, or angina,
- Shortness of breath,
- Abdominal pain, diarrhoea, or
- Thrombosis (blood clotting).
If you have any of these symptoms, contact your doctor.
If you stop using Ultomiris for gMG
Interrupting or stopping treatment with Ultomiris may cause your gMG symptoms to occur. Please speak to your doctor before stopping Ultomiris. Your doctor will discuss the possible side effects and risks with you. Your doctor will also want to monitor you closely.
If you stop using Ultomiris for NMOSD
Interrupting or stopping treatment with Ultomiris may cause NMOSD relapse to occur. Please speak to your doctor before stopping Ultomiris. Your doctor will discuss the possible side effects and risks with you. Your doctor will also want to monitor you closely.
If you have any further questions on the use of this medicine, ask your doctor.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Ultomiris with you prior to treatment.
Serious side effects
The most serious side effect is meningococcal infection including meningococcal sepsis and encephalitis meningococcal .
If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal infection symptoms), you should immediately inform your doctor.
Other side effects
If you are not sure what the side effects below are, ask your doctor to explain them to you.
60 Very common (may affect more than 1 in 10 people):
- Headache
- Dizziness
- Diarrhoea, nausea, abdominal pain
- Fever, feeling tired (fatigue)
- Upper respiratory tract infection
- Common cold (nasopharyngitis)
- Back pain, joint pain (arthralgia)
- Urinary tract infection
Common (may affect up to 1 in 10 people)
- Vomiting, stomach discomfort after meals (dyspepsia)
- Hives, rash, itchy skin (pruritus)
- Muscle pain (myalgia) and muscle spasms
- Influenza like illness, chills, weakness (asthenia)
- Infusion-related reaction
- Allergic reaction (hypersensitivity)
Uncommon (may affect up to 1 in 100 people)
- Meningococcal infection
- Serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction)
- Disseminated gonococcal infection
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Ultomiris
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C).
Do not freeze.
Store in the original package in order to protect from light.
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 4 hours at room temperature.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Ultomiris contains
- The active substance is ravulizumab. Each vial of solution contains 300 mg of ravulizumab.
- The other ingredients are: sodium phosphate dibasic heptahydrate (E 339), sodium phosphate monobasic monohydrate (E 339), polysorbate 80 (E 433), arginine, sucrose, water for injections.
61 This medicine contains sodium and polysorbate 80 (see section 2 “Ultomiris contains sodium” and “Ultomiris contains polysorbate”).
What Ultomiris looks like and contents of the pack
Ultomiris is presented as a concentrate for solution for infusion (3 mL in a vial – pack size of 1).
Ultomiris is a translucent, clear to yellowish colour, practically free from particles solution.
Marketing Authorisation Holder
Alexion Europe SAS 103-105, rue Anatole France 92300 Levallois -Perret France
Manufacturer
Alexion Pharma International Operations Limited Alexion Dublin Manufacturing Facility College Business and Technology Park Blanchardstown Road North Dublin 15, D15 R925 Ireland Almac Pharma Services (Ireland) Limited Finnabair Industrial Estate Dundalk Co. Louth A91 P9KD Ireland Almac Pharma Services Limited 22 Seagoe Industrial Estate Craigavon, Armagh BT63 5QD United Kingdom For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Alexion Pharma Belgium Tél/Tel: +32 0 800 200 31 Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550 България АстраЗенека България ЕООД Teл.: +359 24455000 Luxembourg/Luxemburg Alexion Pharma Belgium Tél/Tel: +32 0 800 200 31 Česká republika AstraZeneca Czech Republic s.r.o.
Tel: +420 222 807 111 Magyarország AstraZeneca Kft.
Tel.: +36 1 883 6500 Danmark Alexion Pharma Nordics AB Tlf.: +46 (0) 8 557 727 50 Malta Alexion Europe SAS Tel: +353 1 800 882 840 Deutschland Alexion Pharma Germany GmbH Tel: +49 (0) 89 45 70 91 300 Nederland Alexion Pharma Netherlands B.V.
Tel: +32 (0) 2 548 36 67 Eesti Norge 62 AstraZeneca Tel: +372 6549 600 Alexion Pharma Nordics AB Tlf: +46 (0) 8 557 727 50 Ελλάδα AstraZeneca A.E.
Τηλ: +30 210 6871500 Österreich Alexion Pharma Austria GmbH Tel: +41 44 457 40 00 España Alexion Pharma Spain, S.L.U Tel: +34 93 272 30 05 Polska AstraZeneca Pharma Poland Sp. z o.o.
Tel.: +48 22 245 73 00 France Alexion Pharma France SAS Tél: +33 1 47 32 36 21 Portugal Alexion Pharma Spain, S.L- Sucursal em Portugal Tel: +34 93 272 30 05 Hrvatska AstraZeneca d.o.o.
Tel: +385 1 4628 000 România AstraZeneca Pharma SRL Tel: +40 21 317 60 41 Ireland Alexion Europe SAS Tel: 1 800 882 840 Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600 Ísland Alexion Pharma Nordics AB Sími: +46 (0) 8 557 727 50 Slovenská republika AstraZeneca AB, o.z.
Tel: +421 2 5737 7777 Italia Alexion Pharma Italy srl Tel: +39 02 7767 9211 Suomi/Finland Alexion Pharma Nordics AB Puh/Tel: +46( 0) 8 557 727 50 Κύπρος Alexion Europe SAS Τηλ: +357 22490305 Sverige Alexion Pharma Nordics AB Tel: +46 ( 0) 8 557 727 50 Latvija SIA AstraZeneca Latvija Tel: +371 67377100
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu/.
63 ————————————————————————————————————————
🩺 Information intended for healthcare professionals only
Instructions for Use for Healthcare Professionals Handling Ultomiris 300 mg/3 mL concentrate for solution for infusion 1- How is Ultomiris supplied?
Each vial of Ultomiris contains 300 mg of active substance in 3 mL of product solution.
In order to improve the traceability of biological medicine, the name and the batch number of the administered product should be clearly recorded.
2- Before administration Dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.
Ultomiris should be prepared for administration by a qualified healthcare professional using aseptic technique.
- Visually inspect Ultomiris solution for particulate matter and discolouration.
- Withdraw the required amount of Ultomiris from the vial(s) using a sterile syringe.
- Transfer the recommended dose to an infusion bag.
- Dilute Ultomiris to a final concentration of 50 mg/mL (initial concentration divided by 2) by adding the appropriate amount of sodium chloride 9 mg/mL (0.9%) solution for injection to the infusion as per the instructions provided in table below.
Table 1: Loading dose administration reference table Body weight range (kg)a Loading dose (mg) Ultomiris volume (mL) Volume of NaCl diluentb (mL) Total volume (mL) Minimum infusion duration minutes (hours) ≥ 10 to < 20c 600 6 6 12 45 (0.8) ≥ 20 to < 30c 900 9 9 18 35 (0.6) ≥ 30 to < 40c 1,200 12 12 24 31 (0.5) ≥ 40 to < 60 2,400 24 24 48 45 (0.8) ≥ 60 to < 100 2,700 27 27 54 35 (0.6) ≥ 100 3,000 30 30 60 25 (0.4) a Body weight at time of treatment b Ultomiris should only be diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection c For PNH and aHUS indications only.
Table 2: Maintenance dose administration reference table Body weight range (kg)a Maintenance dose (mg) Ultomiris volume (mL) Volume of NaCl diluentb (mL) Total volume (mL) Minimum infusion duration minutes (hours) ≥ 10 to < 20c 600 6 6 12 45 (0.8) ≥ 20 to < 30c 2,100 21 21 42 75 (1.3) ≥ 30 to < 40c 2,700 27 27 54 65 (1.1) ≥ 40 to < 60 3,000 30 30 60 55 (0.9) ≥ 60 to < 100 3,300 33 33 66 40 (0.7) ≥ 100 3,600 36 36 72 30 (0.5) a Body weight at time of treatment b Ultomiris should be only diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection c For PNH and aHUS indications only.
64 Table 3: Supplemental dose administration reference table Body weight range (kg)a Supplemental dose (mg) Ultomiris volume (mL) Volume of NaCl diluentb (mL) Total volume (mL) Minimum infusion duration minutes (hr) ≥ 40 to < 60 600 6 6 12 15 (0.25) 1,200 12 12 24 25 (0.42) 1,500 15 15 30 30 (0.5) ≥ 60 to < 100 600 6 6 12 12 (0.20) 1,500 15 15 30 22 (0.36) 1,800 18 18 36 25 (0.42) ≥ 100 600 6 6 12 10 (0.17) 1,500 15 15 30 15 (0.25) 1,800 18 18 36 17 (0.28) a Body weight at time of treatment b Ultomiris should be only diluted using sodium chloride 9 mg/mL (0.9 %) solution for injection
- Gently agitate the infusion bag containing the diluted Ultomiris solution to ensure thorough mixing of the medicine and diluent. Ultomiris should not be shaken.
- The diluted solution should be allowed to warm to room temperature (18 °C–25 °C) prior to administration by exposure to ambient air during approximately 30 min.
- The diluted solution must not be heated in a microwave or with any heat source other than the prevailing room temperature.
- Discard any unused portion left in a vial.
- The prepared solution should be administered immediately following preparation. Infusion must be administered through a 0.2 µm filter. After administration of Ultomiris, flush the entire line with 0.9% Sodium Chloride Injection, USP.
- If the medicine is not used immediately after dilution, storage times must not exceed 24 hours at 2 °C–8 °C or 4 hours at room temperature taking into account the expected infusion time.
3- Administration
- Do not administer Ultomiris as an intravenous push or bolus injection.
- Ultomiris should only be administered via intravenous infusion.
- The diluted solution of Ultomiris should be administered by intravenous infusion over approximately 45 min using a syringe -type pump or an infusion pump. It is not necessary to protect the diluted solution of Ultomiris from light during administration to the patient.
The patient should be monitored for one hour following infusion. If an adverse event occurs during the administration of Ultomiris, the infusion may be slowed or stopped at the discretion of the physician.
4- Special handling and storage Store in a refrigerator (2°C –8°C). Do not freeze. Store in the original package in order to protect from light.
Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.
Any unused medicine or waste material should be disposed of in accordance with local requirements.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Ultomiris (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/19/1371).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.
