Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - rystiggo

Document Subject

Generated Narrative: MedicinalProductDefinition mpb4a7586c3f2386c190c1701cbb794f3c

identifier: http://ema.europa.eu/identifier/EU/1/23/1780/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Rystiggo 140 mg/ml solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

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-b4a7586c3f2386c190c1701cbb794f3c

identifier: http://ema.europa.eu/identifier/EU/1/23/1780/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - rystiggo

Attesters

What is in this leaflet

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

What is Rystiggo

Rystiggo contains the active substance rozanolixizumab. Rozanolixizumab is a monoclonal antibody (a type of protein) designed to recognise and attach to FcRn, a protein that keeps the immunoglobulin G (IgG) antibodies in the body for longer.

Rystiggo is used together with standard therapy in adults to treat generalised myasthenia gravis (gMG), an autoimmune disease that causes muscle weakness which can affect multiple muscle groups throughout the body. The condition can also lead to shortness of breath, extreme fatigue and difficulties swallowing. Rystiggo is used in adults with gMG that produces IgG autoantibodies against acetylcholine receptors or muscle-specific kinase.

In generalised myasthenia gravis (gMG), these IgG autoantibodies (proteins of the immune system that attack parts of a person s own body) attack and damage proteins that are involved in communication between nerves and muscle, called acetylcholine receptors or muscle-specific kinase. By attaching to FcRn, Rystiggo reduces the level of IgG antibodies, including IgG autoantibodies, thereby helping to improve symptom of the disease.

Do not use Rystiggo

• If you are allergic to rozanolixizumab or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using this medicine if any of the following applies to you:

Myasthenic crisis Your doctor may not prescribe this medicine if you are, or are likely to be, on a ventilator due to gMG muscle weakness (myasthenic crisis).

Inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis) Aseptic meningitis has been observed in association with this medicine at a higher dose. Seek immediate medical attention if you develop symptoms of aseptic meningitis such as severe headache, fever, stiffness of the neck, nausea, vomiting and/or intolerance to bright light.

Infections This medicine may reduce your natural resistance to infections. Before starting or during treatment with this medicine, inform your doctor if you have any symptoms of infection (feeling warm, fever, chills or shivering, cough, sore throat or fever blisters may be signs of an infection).

Hypersensitivity (allergic reactions) This medicine contains a protein that can cause reactions such as rash, swelling or itching in some people. You will be monitored for signs of an infusion reaction during and for 15 minutes after treatment.

Immunisations (vaccinations) Please inform your doctor if you have received a vaccine in the last 4 weeks, or if you plan to be vaccinated in the near future.

Children and adolescents

Do not give this medicine to children below the age of 18 years because the use of Rystiggo has not been studied in this age group.

Other medicines and Rystiggo

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

Taking Rystiggo with other medicines may decrease the effectiveness of those medicines, including therapeutic antibodies (such as rituximab) or subcutaneous or intravenous immunoglobulins. Other medicines, including subcutaneous or intravenous immunoglobulins, or interventions such as plasmapheresis (a process in which the liquid part of the blood, or plasma, is separated from blood that has been drawn from a person), may impair the effect of Rystiggo. Tell your doctor if you are taking or planning to take other medicines.

Tell your doctor about your treatment with Rystiggo before you have a vaccination. This medicine may impair the effect of vaccines. Vaccination with so-called live-attenuated or live vaccines is not recommended during treatment with Rystiggo.

Pregnancy and 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.

The effects of this medicine in pregnancy are not known. You should 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 this medicine passes into human milk. Your doctor will help you decide if you should breast-feed and use Rystiggo.

Driving and using machines

Rystiggo is not likely to affect your driving and use of machines.

Rystiggo contains proline

This medicine contains 29 mg of proline in each ml of medicine. Proline may be harmful for patients with hyperprolinaemia, a rare genetic disorder in which an excess of the amino acid, proline, builds up in the body. If you have hyperprolinaemia, tell your doctor and do not use this medicine unless your doctor has recommended it.

Treatment with Rystiggo will be initiated and supervised by a specialist physician experienced in the management of neuromuscular or neuro-inflammatory disorders.

How much Rystiggo is given and for how long

You will be given Rystiggo in cycles of 1 infusion per week for 6 weeks.
Your doctor will calculate the correct dose for you based on your weight:

• if you weigh at least 100 kg, the recommended dose is 840 mg per infusion (requiring 6 ml per administration)
• if you weigh from 70 kg to less than 100 kg, the recommended dose is 560 mg per infusion (requiring 4 ml per administration)
• if you weigh from 50 kg to less than 70 kg, the recommended dose is 420 mg per infusion (requiring 3 ml per administration)
• if you weigh from 35 kg to less than 50 kg, the recommended dose is 280 mg per infusion (requiring 2 ml per administration)

The frequency of treatment cycles varies for each patient and your doctor will consider if and when a new treatment cycle is appropriate for you.

Your doctor will advise you on how long you should be treated with this medicine.

How Rystiggo is given

Rystiggo will be given to you by a doctor or nurse.

You will be given this medicine as an infusion under the skin (subcutaneous use). It is usually injected into the lower part of the tummy, below the belly button. Injections should not be given into areas where the skin is tender, bruised, red or hard.

Each administration is done using an infusion pump set at a flow rate up to 20 ml/hr.

If you receive more Rystiggo than you should

If you suspect that you have been accidentally administered a higher dose of Rystiggo than prescribed, please contact your doctor for advice.

If you forget or miss an appointment to receive Rystiggo

If you miss a dose, please contact your doctor immediately for advice and to schedule another appointment to receive Rystiggo within the next 4 days. Thereafter, the next dose should be given according to the original dosing schedule until the treatment cycle is completed.

If you stop using Rystiggo

Do not stop using this medicine without talking to your doctor first. Interrupting or stopping treatment with Rystiggo may cause your symptoms of generalised myasthenia gravis to come back.

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.

The below side effects, presented in order of decreasing frequency, have been observed with Rystiggo:

Very common: may affect more than 1 in 10 people

• Headache (including migraine)
• Diarrhoea
• Fever (pyrexia)

Common: may affect up to 1 in 10 people

• Rapid swelling under the skin in areas such as the face, throat, arms and legs (angioedema)
• Joint pain (arthralgia)
• Skin rash, sometimes with red bumps (rash papular)
• Injection site reaction including injection site rash, redness of the skin (erythema), inflammation, discomfort, and infusion site pain

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 vial 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 vial in the outer carton in order to protect from light.

Each vial of solution for injection must be used only once (single use). Any unused product or waste material should be disposed of in accordance with local requirements.

Do not use this medicine if you notice that the liquid looks cloudy, contains foreign particles, or has changed colour. 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 Rystiggo contains

• The active substance is rozanolixizumab. Each ml of solution contains 140 mg of rozanolixizumab. Each vial of 2 ml contains 280 mg rozanolixizumab.
• The other ingredients are: histidine, histidine hydrochloride monohydrate, proline, polysorbate 80, and water for injections. See section 2 Rystiggo contains proline.

What Rystiggo looks like and contents of the pack

Rystiggo is a solution for injection. Each carton contains 1 vial of 2 ml solution for injection. The solution is colourless to pale brownish-yellow, clear to slightly opalescent.
The devices used for administration should be procured separately.

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 S.A./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 Rom nia UCB Pharma Romania S.R.L. Tel: + 40 21 300 29 Ireland UCB (Pharma) Ireland Ltd. Tel: + 353 / (0)1-46 37 Slovenija Medis, d.o.o. Tel: + 386 1 589 69 sland Vistor hf. S mi: + 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: