Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - zilbrysq

Document Subject

Generated Narrative: MedicinalProductDefinition mp46af9fe042942e0b323406b7f9580690

identifier: http://ema.europa.eu/identifier/EU/1/23/1764/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Zilbrysq 16.6 mg solution for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-46af9fe042942e0b323406b7f9580690

identifier: http://ema.europa.eu/identifier/EU/1/23/1764/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - zilbrysq

Attesters

What is in this leaflet

1. What Zilbrysq is and what it is used for
2. What you need to know before you use Zilbrysq
3. How to use Zilbrysq
4. Possible side effects
5. How to store Zilbrysq
6. Contents of the pack and other information

Zilbrysq contains the active substance zilucoplan. Zilucoplan attaches to and blocks a protein in the body known as the C5 complement protein, which is a part of the immune system (the body s natural defences). By blocking this protein, zilucoplan prevents the body s immune system from attacking and destroying connections between nerves and muscles, thereby improving symptoms of the disease.

Zilbrysq is used together with standard therapy to treat adult patients with generalised myasthenia gravis (gMG), an autoimmune disease that causes muscle weakness. It is used in adults whose immune system produces antibodies against a protein called the acetylcholine receptor, located on muscle cells. In patients with gMG, the muscles can be attacked and damaged by the immune system, which can lead to profound muscle weakness, impaired mobility, shortness of breath, extreme tiredness, difficulties swallowing and markedly impaired activities of daily living.

Zilbrysq can reduce symptoms of the disease and improve the quality of life.

Do not use Zilbrysq

• if you are allergic to zilucoplan or any of the other ingredients of this medicine (listed in section 6).
• if you have not been vaccinated against meningococcal infection. See warnings and precautions section.
• if you have a meningococcal infection.

Warnings and precautions
Meningococcal and other Neisseria infections alert As Zilbrysq inhibits the body s natural defences against infection, its use may increase your risk of infections caused by Neisseria meningitidis, such as meningococcal infection (severe infection of the linings of the brain and spinal cord and/or an infection of the blood) and also of other infections caused by Neisseria bacteria, such as gonorrhea.

Consult your doctor before you take Zilbrysq to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, 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 received your first vaccine dose. Ensure that your meningococcal vaccinations are up to date. You should be aware that vaccination may not always prevent this type of infection.

If you are at risk of gonorrhoea (sexually transmitted bacterial infection), ask your doctor for advice before using this medicine.

Meningococcal infection symptoms Because of the importance of rapidly identifying and treating meningococcal infections in patients who receive Zilbrysq, you will be provided a card to carry with you at all times, listing specific signs and symptoms of possible meningococcal infection. It also contains information for healthcare professionals that may not be familiar with Zilbrysq. This card is named patient alert card . You will also be provided a patient/carer guide which contains further information on Zilbrysq.

If you experience any of the following symptoms, you should immediately inform your doctor:

• Headache with additional symptoms such as nausea (feeling sick), vomiting, fever and stiff neck or back
• Fever with or without a rash
• Eyes sensitive to light
• Confusion / drowsiness
• Muscle pain with flu-like symptoms

Treatment for meningococcal infection while travelling If you are travelling in a region where you are unable to contact your doctor or will temporarily be 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 antibiotic treatment as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotic treatment.

Children and adolescents Do not give this medicine to children below the age of 18 years. Zilbrysq has not been studied in this age group.

Other medicines and Zilbrysq Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility 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 taking this medicine.

There is uncertainty about the effects that Zilbrysq can have to your unborn child, so do not use this medicine if you are pregnant or think that you may be pregnant unless your doctor specifically recommends it.

It is not known whether Zilbrysq passes into human milk. There may be a risk to newborns/infants.

A decision must be made whether to discontinue breast feeding or to discontinue Zilbrysq therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.

Driving and using machines Zilbrysq is not likely to affect your ability to drive or use machines.

Zilbrysq contains sodium This medicine contains less than 23 mg of sodium per pre-filled syringe, that is to say essentially sodium-free .

At least 2 weeks before you start treatment with Zilbrysq, your doctor will give you a vaccine against meningococcal infection if you have not previously received it or if your vaccination is outdated. If you cannot be vaccinated at least 2 weeks before you start treatment with Zilbrysq, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have received your first vaccine dose.

Before you start treatment you should also discuss with your doctor if you need any other vaccines.

After suitable training, your doctor will allow you to inject Zilbrysq yourself. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

The dose you receive will depend on your bodyweight. Always administer your daily dose at approximately the same time of the day.

The following table indicates the total daily dose of Zilbrysq according to your body weight:

Body weight
Dose Number of pre-filled syringes by colour < 56 kg 16.6 mg 1 (Rubine red)
56 to < 77 kg 23 mg 1 (Orange)
77 kg 32.4 mg 1 (Dark blue)

How Zilbrysq is given You and your doctor or nurse will decide if you can inject this medicine yourself. Do not self-inject this medicine unless you have been trained by a healthcare professional. Another person may also give your injections after they have been trained.

Zilbrysq will be given as a subcutaneous injection (an injection under the skin) once a day. It can be injected into the stomach area, the front of the thighs or the back of the upper arms. Injections in the back of the upper arms should only be given by another person. The injection location should be rotated and should not be given into areas where the skin is tender, bruised, red or hard or where the skin has scars or stretch marks.

It is important that you read the instructions for use at the end of the package leaflet for detailed information on how to use Zilbrysq.

If you use more Zilbrysq than you should If you suspect that you have accidentally received a higher dose of Zilbrysq than prescribed, please contact your doctor for advice.

If you forget to use Zilbrysq If you didn't inject the dose at the usual time or missed a dose, please inject as soon as you realize it and then continue with the dosing at the normal time the next day. Do not administer more than one dose per day.

If you stop using Zilbrysq Interrupting or stopping treatment with Zilbrysq may cause your symptoms to come back. Please speak to your doctor before stopping Zilbrysq. Your doctor will discuss the possible side effects and risks with you. Your doctor may also want to monitor you closely.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people)

• Injection site reactions, such as bruising, pain, itching and forming of a lump.
• Nose and throat infections.

Common (may affect up to 1 in 10 people)

• Diarrhoea
• Increased pancreas enzymes (amylase, lipase) seen in blood test.

Morphoea (condition that causes localized discolored and hardened areas of the skin).

Uncommon (may affect up to 1 in 100 people)

• Increased of eosinophils (a type of white blood cell), seen in blood test.

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.

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 syringe label and outer 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. Keep the pre-filled syringe in the outer carton in order to protect from light.

You may store the Zilbrysq pre-filled syringe at room temperature in the original carton up to 30 C for only one single period of up to 3 months. Once Zilbrysq has been removed from the refrigerator, it should not be placed back into the refrigerator. The product must be discarded if not used within 3 months or when the expiry date is reached, whichever occurs first.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Zilbrysq contains

• The active substance is: zilucoplan.
• The other ingredients are: sodium dihydrogen phosphate monohydrate, disodium phosphate (anhydrous), sodium chloride, water for injections (see section 2 Zilbrysq contains sodium).

What Zilbrysq looks like and contents of the pack Zilbrysq is a solution for injection in pre-filled syringe (injection) and is a clear to slightly opalescent and colourless solution, free of visible particles.

Zilbrysq 16.6 mg solution for injection in pre-filled syringe Each pre-filled syringe with rubine red plunger contains zilucoplan sodium equivalent to 16.6 mg zilucoplan in 0.416 mL.

Zilbrysq 23 mg solution for injection in pre-filled syringe Each pre-filled syringe with orange plunger contains zilucoplan sodium equivalent to 23 mg zilucoplan in 0.574 mL.

Zilbrysq 32.4 mg solution for injection in pre-filled syringe Each pre-filled syringe with dark blue plunger contains zilucoplan sodium equivalent to 32.4 mg zilucoplan in 0.810 mL.

Pack size of 7 pre-filled syringes for 16.6 mg, 23 mg and 32.4 mg solution for injection. Multipack containing 28 (4 packs of 7) pre-filled syringes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
UCB Pharma S.A., All e de la Recherche 60, B-1070 Bruxelles, Belgium

Manufacturer UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l Alleud, Belgium.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien UCB Pharma S.A./NV
T l/Tel: + 32 / (0)2 559 92 Lietuva UAB Medfiles Tel: + 370 5 246 16

Te .: + 359 (0) 2 962 30 Luxembourg/Luxemburg UCB Pharma SA/NV
T l/Tel: + 32 / (0)2 559 92 00 (Belgique/Belgien)

esk republika UCB s.r.o.
Tel: + 420 221 773 Magyarorsz g UCB Magyarorsz g Kft.
Tel.: + 36-(1) 391 0Danmark UCB Nordic A/S
Tlf: + 45 / 32 46 24 Malta Pharmasud Ltd.
Tel: + 356 / 21 37 64 Deutschland UCB Pharma GmbH
Tel: + 49 /(0) 2173 48 4Nederland UCB Pharma B.V.
Tel: + 31 / (0)76-573 11 Eesti O Medfiles Tel: + 372 730 5Norge UCB Nordic A/S
Tlf: + 47 / 67 16 5
UCB . .
: + 30 / 2109974 sterreich UCB Pharma GmbH
Tel: + 43-(0)1 291 80 Espa a UCB Pharma, S.A.
Tel: + 34 / 91 570 34 Polska UCB Pharma Sp. z o.o. / VEDIM Sp. z o.o. Tel: + 48 22 696 99 France UCB Pharma S.A.
T l: + 33 / (0)1 47 29 44 Portugal UCB Pharma (Produtos Farmac uticos), Lda
Tel: + 351 21 302 5Hrvatska Medis Adria d.o.o.
Tel: +385 (0) 1 230 34 Ireland UCB (Pharma) Ireland Ltd.
Tel: + 353 / (0)1-46 37 Rom nia UCB Pharma Romania S.R.L.
Tel: + 40 21 300 29 Slovenija Medis, d.o.o.
Tel: + 386 1 589 69 sland Vistor hf.
Simi: + 354 535 7Slovensk republika UCB s.r.o., organiza n zlo ka
Tel: + 421 (0) 2 5920 2Italia UCB Pharma S.p.A.
Tel: + 39 / 02 300 Suomi/Finland UCB Pharma Oy Finland
Puh/Tel: + 358 9 2514 4
Lifepharma (Z.A.M.) Ltd
: + 357 22 056Sverige UCB Nordic A/S
Tel: + 46 / (0) 40 294 Latvija Medfiles SIA Tel: + 371 67 370 United Kingdom (Northern Ireland) UCB (Pharma) Ireland Ltd.
Tel : + 353 / (0)1-46 37 This leaflet was last revised in .

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: