Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vyvgart

Document Subject

Generated Narrative: MedicinalProductDefinition mpf819453f37e8574dc396f13201d03208

identifier: http://ema.europa.eu/identifier/EU/1/22/1674/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vyvgart 20 mg/mL concentrate for solution for infusion

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-f819453f37e8574dc396f13201d03208

identifier: http://ema.europa.eu/identifier/EU/1/22/1674/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vyvgart

Attesters

What is in this leaflet

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

What Vyvgart is Vyvgart contains the active substance efgartigimod alfa. Efgartigimod alfa binds to and blocks a protein in the body called neonatal Fc receptor (FcRn). By blocking FcRn, efgartigimod alfa decreases the level of IgG autoantibodies which are proteins of the immune system that attack parts of a person s own body by mistake.

What Vyvgart is used for Vyvgart is used together with standard therapy to treat adults with generalised Myasthenia Gravis (gMG), an autoimmune disease that causes muscle weakness. gMG can affect multiple muscle groups throughout the body. The condition can also lead to shortness of breath, extreme fatigue and difficulties swallowing.

In patients with gMG, IgG autoantibodies attack and damage proteins on nerves called acetylcholine receptors. Because of this damage, the nerves are not able to make the muscles contract as well as normal, leading to muscle weakness and difficulty moving. By binding to the FcRn protein and reducing autoantibody levels, Vyvgart can improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on daily activities.

Do not use Vyvgart

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

Warnings and precautions Talk to your doctor before using Vyvgart.

MGFA class V Your doctor may not prescribe this medicine if you are on a ventilator due to gMG muscle weakness (myasthenic crisis).

Infections Vyvgart treatment may reduce your natural resistance to infections. Therefore, before starting Vyvgart, inform your doctor if you have any infections.

Infusion reactions and allergic reactions Vyvgart contains a protein that can cause reactions such as rash or itching in some people. Vyvgart may cause anaphylactic reaction (a serious allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat or tongue which makes it difficult to swallow or breathe, or shortness of breath, feeling of losing consciousness, or skin rash during or after the infusion, then tell your doctor immediately.
You will be monitored for signs of an infusion reaction or allergic reaction during and for 1 hour 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 18 years of age because the safety and efficacy of Vyvgart have not been established in this population.

Elderly There are no special precautions needed for the treatment of patients who are older than 65 years of age.

Other medicines and Vyvgart Tell your doctor 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.

Driving and using machines Vyvgart is not expected to influence the ability to drive or use machines.

Vyvgart contains sodium This medicine contains 67.2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.4% of the recommended maximum daily dietary intake of sodium for an adult.

The treatment will be given by your doctor or other health care provider. Your healthcare provider will first dilute the product. The dilution will be administered from a drip bag through a tube directly into one of your veins over the course of 1 hour.

What dose of Vyvgart you will receive and how often The dose you receive will depend on your bodyweight, and will be administered in cycles of one infusion per week for 4 weeks. Your doctor will determine when further treatment cycles are needed. Instructions for the healthcare provider on the proper use of this medicine are provided at the end of this document.

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

If you forget an appointment to receive Vyvgart If you forget an appointment, please contact your doctor immediately for advice and see section below If you stop using Vyvgart .

If you stop using Vyvgart Interrupting or stopping treatment with Vyvgart may cause your gMG symptoms to come back. Please speak to your doctor before stopping Vyvgart. 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.

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 Vyvgart with you prior to treatment.

Tell your doctor straight away if you notice:
Signs of a serious allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue which makes it difficult to swallow or breathe, shortness of breath, feeling of loss of consciousness, or skin rash during or after the infusion. If you are not sure what the side effects below are, ask your doctor to explain them to you.

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

• nose and throat (upper respiratory tract) infections

Common (may affect up to 1 in 10 people)

• pain or a burning sensation during urination, which may be a sign of a urinary tract infection
• inflammation of the airways in the lungs (bronchitis)
• muscle pain (myalgia)
• headache during or after the administration of Vyvgart

Not known

• Allergic reactions during or after infusion
• swelling of the face, lips, throat, or tongue which makes it difficult to swallow or breathe, shortness of breath
• pale skin, a weak and rapid pulse, or a feeling of loss of consciousness
• sudden rash, itching, or hives.

Reporting of side effects If you get any side effects, talk to your doctor. 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 carton and on the label 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.

Do not use this medicine if visible particles are observed and/or the liquid in the vial is discoloured.

After dilution the product should be used immediately and the infusion (drip) should be completed within 4 hours of dilution. Allow the diluted medicinal product to reach room temperature before administration. The infusion should be completed within 4 hours of removal from the refrigerator.

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 Vyvgart contains The active substance is efgartigimod alfa.

• Each 20 mL vial contains 400 mg efgartigimod alfa (20 mg/mL). The other ingredients are:

• sodium dihydrogen phosphate, monohydrate

• disodium hydrogen phosphate, anhydrous

• sodium chloride

• arginine hydrochloride

• polysorbate - water for injections

What Vyvgart looks like and contents of the pack Vyvgart is presented as a sterile concentrate for intravenous (IV) infusion (20 mL in a vial pack size of 1). Vyvgart is a liquid. It is colourless to slightly yellow, clear to almost clear.

Marketing Authorisation Holder and Manufacturer argenx BV Industriepark-Zwijnaarde 7 9052 Gent Belgium

Manufacturer Propharma Group The Netherlands Schipholweg 2316 ZL Leiden The Netherlands

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

Belgi /Belgique/Belgien/Eesti argenx BV T l/Tel: +32 (0) 9 3969394 / +32 (0) 800 54medinfobe@argenx.com Lietuva argenx BV Tel: 8 800 80 medinfolt@argenx.com

argenx BV Te .: 0800 46 medinfobg@argenx.com

Luxembourg/Luxemburg argenx BV T l/Tel: 800 25 medinfolu@argenx.com

esk republika argenx BV Tel: 800 040 medinfocz@argenx.com

Magyarorsz g argenx BV Tel.: (80) 088 medinfohu@argenx.com

Danmark argenx BV Tlf: 80 25 41 medinfodk@argenx.com

Malta argenx BV Tel: 8006 5medinfomt@argenx.com

Deutschland argenx Germany GmbH Tel: 08001803medinfode@argenx.com

Nederland argenx BV Tel: 0800 0232medinfonl@argenx.com

Medison Pharma Greece Single Member Societe Anonyme
: +30 210 0100 medinfogr@argenx.com

Norge argenx BV Tlf: 800 62 medinfono@argenx.com

Espa a argenx BV Tel: 900 876 medinfoes@argenx.com

sterreich argenx BV Tel: 0800 017medinfoat@argenx.com France argenx France SAS T l: +33 (0) 1 88898medinfofr@argenx.com

Polska argenx BV Tel.: 800 005 medinfopl@argenx.com Hrvatska argenx BV Tel: 0800 806 medinfohr@argenx.com

Portugal argenx BV Tel: 800 180 medinfopt@argenx.com

Ireland/United Kingdom (Northern Ireland) argenx BV Tel: 1800 851 medinfoie@argenx.com

Rom nia argenx BV Tel: 0800 360 medinforo@argenx.com

sland argenx BV S mi: 800 4medinfois@argenx.com

Slovenija argenx BV Tel: 080 688medinfosi@argenx.com

Italia argenx Italia s.r.l Tel: 800776medinfoit@argenx.com

Slovensk republika argenx BV Tel: 0800 002 medinfosk@argenx.com

argenx BV : 80 077medinfocy@argenx.com

Suomi/Finland argenx BV Puh/Tel: 0800 412medinfofi@argenx.com

Latvija argenx BV Tel: 80 205 medinfolv@argenx.com

Sverige argenx BV Tel: 020-12 74 medinfose@argenx.com

This leaflet was last revised in.

Other sources of information

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