VYVGART 20 mg /Ml Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Vyvgart 20 mg/mL concentrate for solution for infusion
   1. What is Vyvgart and what is it used for
   2. What you need to know before using Vyvgart
   3. How to use Vyvgart
   4. Possible side effects
   5. How to store Vyvgart
   6. Contents of the pack and other information
   7. How is Vyvgart supplied?
   8. Before administration
   9. Preparation and Administration
   10. Special Handling and Storage Instructions
2. Vyvgart 1 000 mg injectable solution
   1. What is Vyvgart and what is it used for
   2. What you need to know before using Vyvgart
   3. How to use Vyvgart
   4. Possible side effects
   5. How to store Vyvgart
   6. Contenuto della confezione e altre informazioni
3. Vyvgart 1 000 mg injectable solution in pre-filled syringe
   1. What is Vyvgart and what is it used for
   2. What you need to know before using Vyvgart
   3. How to use Vyvgart
   4. Possible side effects
   5. How to store Vyvgart
   6. Contents of the pack and other information
   7. Remove the package from the refrigerator
   8. Check the prefilled syringe before
   9. Allow the pre-filled syringe to
   10. Gather the materials and wash your hands
   11. Remove the syringe cap
   12. Choose and clean the injection site
   13. Pull back the needle shield
   14. Perform the injection
   15. Cover the needle and dispose of the used syringe

Vyvgart 20 mg/mL concentrate for solution for infusion

efgartigimod alfa

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is Vyvgart and what is it used for

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

What is Vyvgart used for
Vyvgart is used in combination with standard therapy in the treatment of adults with generalized myasthenia gravis
(gMG), an autoimmune disease that causes muscle weakness. Generalized myasthenia gravis can affect multiple
muscle groups throughout the body. The disease can also cause shortness of breath, extreme fatigue, and difficulty
swallowing.
In patients with generalized myasthenia gravis, IgG autoantibodies attack and damage certain
proteins on the nerves called acetylcholine receptors. Due to this damage, the nerves are unable to
cause the muscles to contract as effectively as usual, leading to muscle weakness and difficulty of
movement. By binding to the FcRn protein and reducing levels of autoantibodies, Vyvgart can
improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on
daily activities.

2. What you need to know before using Vyvgart

Do not use Vyvgart

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

Warnings and precautions
Talk to your doctor before using Vyvgart.
Class V according to the MGFA
Your doctor may not prescribe this medicine if you are undergoing ventilation due to
muscle weakness from gMG (myasthenic crisis).
Infections
Treatment with Vyvgart may reduce natural resistance to infections. Therefore, before starting to
use Vyvgart, tell your doctor if you have any infections.
Infusion reactions and allergic reactions
Vyvgart contains a protein that may cause reactions such as rash or itching in some people. Vyvgart
may cause anaphylaxis (a severe allergic reaction). If allergic reactions appear
such as swelling of the face, lips, throat or tongue that make it difficult to swallow or
breathe, shortness of breath, feeling of loss of consciousness or skin rash during or after
the infusion, tell your doctor immediately.
You will be monitored for any signs of an infusion reaction or allergic reaction during and for
1 hour after treatment.
Immunizations (vaccinations)
Tell your doctor if you have received a vaccine in the last 4 weeks, or if you are due to receive a
vaccination soon.

Children and adolescents
Do not give this medicine to children under 18 years of age as the safety and efficacy of
Vyvgart have not been established in this population.

Elderly
No special precautions are necessary for the treatment of patients over 65 years of age.

Other medicines and Vyvgart
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Vyvgart is not expected to affect the ability to drive vehicles and operate machinery.

Vyvgart contains sodium
This medicine contains 67.2 mg of sodium (the main component of table salt) per
vial. This is equivalent to 3.4% of the maximum daily recommended intake of sodium for
an adult. This medicine will be further prepared for administration with a solution
containing sodium. This must be taken into consideration in relation to the total
daily sodium intake from all sources by the patient.

Vyvgart contains polysorbate
This medicine contains 4.1 mg of polysorbate 80 per vial equivalent to 0.2 mg/mL. Polysorbates
may cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Vyvgart

The treatment will be administered to you by your doctor or other healthcare professional. The healthcare professional will first dilute the product. The dilution will be administered from an infusion bag through a tube directly into a vein over 1 hour.

What dose of Vyvgart you will receive and how often
The dose you will receive will depend on your body weight and will be administered in cycles of one infusion per week for 4 weeks. The doctor will determine when further treatment cycles are necessary.
Instructions for the healthcare professional regarding the correct use of this medicine are included at the end of this document.

If you receive too much Vyvgart
If you suspect that you have been accidentally given a dose of Vyvgart higher than prescribed, consult your doctor.

If you miss an appointment for Vyvgart administration
If you miss an appointment, consult your doctor immediately and refer to the next paragraph “If you stop treatment with Vyvgart”.

If you stop treatment with Vyvgart
Stopping or interrupting treatment with Vyvgart may cause the reappearance of symptoms of generalized myasthenia gravis. Consult your doctor before stopping treatment with Vyvgart.
The doctor will discuss with you the possible undesirable effects and risks. The doctor will also want to keep you under close supervision.
If you have any doubts about 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.
Before treatment, your doctor will discuss possible side effects with you and explain the risks
and benefits of Vyvgart.

Tell your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or
tongue that 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 have any doubts about the side effects listed below, ask your doctor for clarification.

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

• upper respiratory tract infections (nose and throat infections).

Common(may affect up to 1 in 10 people)

• pain or 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
• nausea.

Not known(frequency cannot be estimated from available data)

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet. You can also report side effects directly through the national reporting system
mentioned in Appendix V. By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Vyvgart

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 package and 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 to protect the medicine from light.
Do not use this medicine if you notice visible particles and/or if the color of the liquid in the vial has
changed.
The product must be used immediately after dilution and the infusion (drip) must be completed
within 4 hours of dilution. Wait for the diluted medicine to reach room temperature
before administration. The infusion must be completed within 4 hours of removal
from the refrigerator.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vyvgart contains
The active ingredient is efgartigimod alfa.

• Each 20 mL vial contains 400 mg of efgartigimod alfa (20 mg/mL). The other ingredients are:
• monobasic disodium phosphate monohydrate
• anhydrous disodium hydrogen phosphate
• sodium chloride
• arginine hydrochloride
• polysorbate 80 (E433)
• water for injections

Description of Vyvgart and contents of the pack
Vyvgart is presented as a sterile concentrate for intravenous (i.v.) infusion (20 mL in a
vial – pack of 1 vial).
Vyvgart is a liquid. It is colourless to slightly yellow, clear or almost clear.

Marketing authorisation holder and manufacturer
argenx BV
Industriepark‑Zwijnaarde 7
9052 Gent
Belgium

Manufacturer
Propharma Group The Netherlands
Schipholweg 73
2316 ZL Leiden
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
argenx BV
Tél/Tel: +32 (0)9 39 69 394/+32 (0)800 54 477
[email protected]

Lietuva
argenx BV
Tel: +370 (0)800 80 052
[email protected]

България
argenx BV
Teл.: +359 (0)800 46 273
[email protected]

Luxembourg/Luxemburg
argenx BV
Tél/Tel: +352 800 25 233
[email protected]

Česká republika
argenx BV
Tel: +420 800 040 854
[email protected]

Magyarország
argenx BV
Tel.: +36 800 88 578
[email protected]

Danmark
argenx BV
Tlf.: +45 80 25 41 88
[email protected]

Malta
argenx BV
Tel: +356 800 65 101
[email protected]

Deutschland
argenx Germany GmbH
Tel: +49 (0)800 180 3963
[email protected]

Nederland
argenx BV
Tel: +31 (0)800 023 2882
[email protected]

Eesti
argenx BV
Tel: +372 800 010 0919
[email protected]

Norge
argenx BV
Tlf: +47 800 62 225
[email protected]

Ελλάδα
Medison Pharma Greece Single Member
Societe Anonyme
Τηλ: +30 210 0100 188
[email protected]

Österreich
argenx BV
Tel: +43 (0)800 017936
[email protected]

España
argenx Spain S.L.
Tel: +34 900 876 188
[email protected]

Polska
argenx BV
Tel.: +48 800 005 155
[email protected]

France
argenx France SAS
Tél: +33 (0)1 88 89 89 92
[email protected]

Portugal
argenx Spain S.L. Sucursal Em Portugal
Tel: +351 800 180 844
[email protected]

Hrvatska
argenx BV
Tel: +385 (0)800 806 524
[email protected]

România
argenx BV
Tel: +40 (0)800 360 912
[email protected]

Ireland
argenx BV
Tel: +353 1800 851 868
[email protected]

Slovenija
argenx BV
Tel: +386 (0)80 688 955
[email protected]

Ísland
argenx BV
Sími: +354 800 4422
[email protected]

Slovenská republika
argenx BV
Tel: +421 (0)800 002 646
[email protected]

Italia
argenx Italia s.r.l
Tel: +39 800 729 052
[email protected]

Suomi/Finland
argenx BV
Puh/Tel: +358 (0)800 412 838
[email protected]

Κύπρος
argenx BV
Τηλ: +357 800 77 122
[email protected]

Sverige
argenx BV
Tel: +46 (0)20 12 74 56
[email protected]

Latvija
argenx BV
Tel: +371 80 205 267
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website, https://www.ema.europa.eu. Links to other websites on rare diseases and related therapeutic treatments are also provided.
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The following information is intended exclusively for healthcare professionals:

Instructions for use for healthcare professionals handling Vyvgart

1. How is Vyvgart supplied?

Each vial contains 400 mg of efgartigimod alfa at a concentration of 20 mg/mL, to be
diluted in sodium chloride 9 mg/mL (0.9%) injectable solution.

2. Before administration

Reconstitution and dilution must be performed in accordance with good practice guidelines, in
particular with respect to aseptic technique.
Vyvgart must be prepared for administration by a qualified healthcare professional using
aseptic technique.
Using the formula in the table below, calculate the following:

• The dose of Vyvgart needed based on the patient's body weight at the recommended dose of 10 mg/kg. For patients weighing more than 120 kg, calculate the dose considering a body weight of 120 kg. The maximum total dose per infusion is 1,200 mg. Each vial contains 400 mg of efgartigimod alfa at a concentration of 20 mg/mL.
• The number of vials needed.
• The volume of sodium chloride 9 mg/mL (0.9%) injectable solution. The total volume of diluted medicine is 125 mL.

Table 1. Formula

3. Preparation and Administration

• Do not administer Vyvgart as a rapid injection or intravenous bolus injection.
• Vyvgart must be administered exclusively by intravenous infusion as described below.

Preparation

• Visually inspect the vial contents to ensure they are clear to slightly opalescent, from colorless to slightly yellow, and free from particulate matter. If visible particles and/or a change in the color of the liquid in the vial is observed, the vial must be discarded. Do not shake the vials.
• Using aseptic technique for the entire preparation of the diluted solution:
• Slowly withdraw the required amount of Vyvgart from the appropriate number of vials using a sterile syringe and needle. Discard partially used or empty vials.
• Transfer the calculated dose of the product into an infusion bag.
• Dilute the withdrawn product by adding the calculated amount of sodium chloride 9 mg/mL (0.9%) injectable solution to obtain a total volume of 125 mL.
• Gently invert the infusion bag containing the diluted product withoutshakingto ensure thorough mixing of the product and diluent.
• The efgartigimod alfa solution diluted in sodium chloride 9 mg/mL (0.9%) injectable solution can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and ethylene/propylene copolymer (polyolefin) bags, as well as PE, PVC and polyurethane/polypropylene infusion lines, together with polyurethane (PUR) or PVC filters, with a polyethersulfone (PES) or polyvinylidene fluoride (PVDF) filter membrane.

Administration

• Vyvgart must be administered by intravenous infusion by a healthcare professional. Do not administer as a rapid injection or intravenous bolus injection.
• Visually inspect the solution for the presence of particulate matter before administration.
• Infuse the total 125 mL of diluted medicine over 1 hour using a 0.2 µm filter. Administer the entire volume of solution. After administration of the product, the line must be flushed with sodium chloride 9 mg/mL (0.9%) injectable solution.
• Administer immediately after dilution and complete the infusion of the diluted solution within 4 hours of dilution.
• Chemical and physical stability has been demonstrated during use for 24 hours at 2 °C - 8 °C. From a microbiological point of view, unless the dilution method excludes the risk of microbial contamination, the product must be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user. Do not freeze. Allow the diluted medicine to reach room temperature before administration. Complete the infusion within 4 hours of removal from the refrigerator. The diluted medicine must only be warmed to room temperature.
• If infusion reactions occur, the infusion rate should be reduced, interrupted or discontinued.
• Do not inject other medicines into the side ports of the infusion or mix them with Vyvgart.

4. Special Handling and Storage Instructions

Store the vials in a refrigerator (2 °C - 8 °C) until the time of use. Do not freeze.
Store in the original packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”.
The expiry date refers to the last day of that month.

Vyvgart 1 000 mg injectable solution

efgartigimod alfa

Medicine subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before you use this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is Vyvgart and what is it used for

What is Vyvgart
Vyvgart contains the active substance efgartigimod alfa. Efgartigimod alfa binds to a protein in the
body called the neonatal Fc receptor (FcRn) and blocks it. By blocking FcRn, efgartigimod alfa
reduces the level of autoantibodies immunoglobulin G (IgG), which are proteins of the immune system
that mistakenly attack certain parts of a person's body.

What is Vyvgart used for
Vyvgart is used with standard therapy in the treatment of adults with generalized myasthenia gravis
(gMG), an autoimmune disease that causes muscle weakness. Generalized myasthenia gravis can affect
multiple muscle groups throughout the body. The disease can also cause
shortness of breath, extreme fatigue and difficulty swallowing.
In patients with generalized myasthenia gravis, IgG autoantibodies attack and damage certain
proteins on the nerves called acetylcholine receptors. Due to this damage, the nerves are unable to
make the muscles contract effectively, 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.
Vyvgart is also used for the treatment of adults with chronic inflammatory demyelinating
polyneuropathy (CIDP), a form of autoimmune disease. CIDP causes muscle weakness and/or numbness
mainly of the legs and arms. Vyvgart can protect the nerves
from attack and reduce the symptoms of the disease and their impact on daily activities.

Vyvgart contains polysorbate
This medicine contains 2.7 mg of polysorbate 20 per vial equivalent to 0.4 mg/mL. Polysorbates can
cause allergic reactions. Tell your doctor if you have any known allergies.

2. What you need to know before using Vyvgart

Do not use Vyvgart

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

Warnings and precautions
Talk to your doctor before using Vyvgart.
Class V according to the MGFA
Your doctor may not prescribe this medicine if you are undergoing ventilation due to
muscle weakness from gMG (myasthenic crisis).
Infections
Treatment with Vyvgart may reduce natural resistance to infections. Therefore, before starting to
use Vyvgart, tell your doctor if you have any infections.
Reactions to the injection and allergic reactions
Vyvgart contains a protein that may cause reactions such as rash or itching in some people. Vyvgart
may cause anaphylaxis (a severe allergic reaction). If allergic reactions appear
such as swelling of the face, lips, throat or tongue that make it difficult to swallow,
breathe, shortness of breath, feeling of loss of consciousness or skin rash during or after
the injection, inform your doctor immediately.
Immunizations (vaccinations)
Tell your doctor if you have received a vaccine in the last 4 weeks, or if you are due to receive a
vaccination soon.

Children and adolescents
Do not give this medicine to children under 18 years of age as the safety and efficacy of
Vyvgart have not been established in this population.

Elderly
No special precautions are necessary for the treatment of patients over 65 years of age.

Other medicines and Vyvgart
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Vyvgart is not expected to affect your ability to drive and operate machinery.

Vyvgart contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per vial, i.e. essentially
“sodium-free”.

3. How to use Vyvgart

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

What dose of Vyvgart you will receive and how often

Generalized Myasthenia Gravis
The recommended dose is 1,000 mg administered in cycles of one injection per week for
4 weeks. The doctor will determine when further treatment cycles are necessary.
If you are already being treated with Vyvgart intravenously and wish to switch to Vyvgart subcutaneously, you must receive the subcutaneous injection instead of the intravenous infusion at the beginning of the
next treatment cycle.

Chronic Inflammatory Demyelinating Polyneuropathy
The recommended dose is 1,000 mg, one injection per week. Based on how you respond to
treatment, your doctor may change the dose to 1 injection every 2 weeks.

Vyvgart Injection
Vyvgart is administered by injection under the skin ( subcutaneous). You and your doctor must
decide whether, after adequate training, you or the person assisting you can inject Vyvgart.
The first self-injection must be performed in the presence of a healthcare professional. It is important not
to attempt to inject Vyvgart before being trained by a healthcare professional.
If you or the person assisting you injects Vyvgart, you must carefully read and follow the Instructions for
Administration at the end of this leaflet (see “Important instructions for use”).
For any questions about self-administration of an injection, consult your doctor, pharmacist or
nurse.

If you use more Vyvgart than you should
Since Vyvgart is administered in a single-use vial, it is unlikely that you will receive an
excessive amount. However, if you are concerned, consult your doctor, pharmacist or nurse.

If you miss a dose or forget an appointment for Vyvgart administration
Keep track of your next dose. It is important to use Vyvgart exactly as prescribed by
your doctor.

• If you miss a dose within three days of the scheduled date, you should take it as soon as you remember and then follow the original dosing schedule.
• If you miss a dose for more than three days, ask your doctor when to take the next dose.
• If you forget an appointment, consult your doctor immediately.

Do not take a double dose to make up for a missed dose.

If you stop taking Vyvgart
Stopping or interrupting treatment with Vyvgart may cause your symptoms to return.
Consult your doctor before stopping treatment with Vyvgart. The doctor will discuss with you the
possible side effects and risks. The doctor will also want to monitor you closely.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Before treatment, your doctor will discuss possible side effects with you and explain the risks
and benefits of Vyvgart.

Tell your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or
tongue that makes it difficult to swallow or breathe, shortness of breath, feeling of loss
of consciousness or skin rash during or after the injection.
For any doubt regarding the side effects listed below, ask your doctor for clarification.

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

• nose and throat infections (upper respiratory tract infections)
• reactions at the injection site, which may include redness, itching and pain. These injection site reactions are usually mild to moderate and usually occur within one day of the injection.

Common(may affect up to 1 in 10 people)

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

Not known(frequency cannot be estimated from available data)

• allergic reactions during or after the injection:
• swelling of the face, lips, throat or tongue that makes it difficult to swallow or breathe, shortness of breath
• paleness, weak and rapid pulse or feeling of loss of consciousness
• sudden onset of skin rash, itching or hives.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Vyvgart

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 pack and 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.
If necessary, closed vials can be stored at room temperature (up to 30 °C) for
a maximum of 3 days. After storage at room temperature, the closed vials can
be returned to the refrigerator. The total time out of the refrigerator and at room temperature must not
exceed 3 days.
Store in the original package to protect the medicine from light.
Do not use this medicine if you notice visible particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contenuto della confezione e altre informazioni

Cosa contiene Vyvgart

• Il principio attivo è efgartigimod alfa. Ciascun flaconcino contiene 1 000 mg di efgartigimod alfa in 5,6 mL. Ogni mL contiene 180 mg di efgartigimod alfa.
• Gli altri componenti sono: ialuronidasi umana ricombinante (rHuPH20), L-istidina, L-istidina cloridrato monoidrato, L-metionina, polisorbato 20 (E432), cloruro di sodio, saccarosio, acqua per preparazioni iniettabili. Vedere il paragrafo 2 “Vyvgart contiene sodio”.

Descrizione dell’aspetto di Vyvgart e contenuto della confezione
Vyvgart è una soluzione pronta all’uso, leggermente gialla, da limpida a leggermente torbida, fornita
come soluzione per iniezione sottocutanea.

Titolare dell’autorizzazione all’immissione in commercio e produttore
argenx BV
Industriepark‑Zwijnaarde 7
9052 Gent
Belgio
Per ulteriori informazioni su questo medicinale, contatti il rappresentante locale del titolare
dell’autorizzazione all’immissione in commercio:

België/Belgique/Belgien
argenx BV
Tél/Tel: +32 (0)9 39 69 394/+32 (0)800 54 477
[email protected]

Lietuva
argenx BV
Tel: +370 (0)800 80 052
[email protected]

България
argenx BV
Teл.: +359 (0)800 46 273
[email protected]

Luxembourg/Luxemburg
argenx BV
Tél/Tel: +352 800 25 233
[email protected]

Česká republika
argenx BV
Tel: +420 800 040 854
[email protected]

Magyarország
argenx BV
Tel.: +36 800 88 578
[email protected]

Danmark
argenx BV
Tlf.: +45 80 25 41 88
[email protected]

Malta
argenx BV
Tel: +356 800 65 101
[email protected]

Deutschland
argenx Germany GmbH
Tel: +49 (0)800 180 3963
[email protected]

Nederland
argenx BV
Tel: +31 (0)800 023 2882
[email protected]

Eesti
argenx BV
Tel: +372 800 010 0919
[email protected]

Norge
argenx BV
Tlf: +47 800 62 225
[email protected]

Ελλάδα
Medison Pharma Greece Single Member Societe
Anonyme
Τηλ: +30 210 0100 188
[email protected]

Österreich
argenx BV
Tel: +43 (0)800 017936
[email protected]

España
argenx Spain S.L.
Tel: +34 900 876 188
[email protected]

Polska
argenx BV
Tel.: +48 800 005 155
[email protected]

France
argenx France SAS
Tél: +33 (0)1 88 89 89 92
[email protected]

Portugal
argenx Spain S.L. Sucursal Em Portugal
Tel: +351 800 180 844
[email protected]

Hrvatska
argenx BV
Tel: +385 (0)800 806 524
[email protected]

România
argenx BV
Tel: +40 (0)800 360 912
[email protected]

Ireland
argenx BV
Tel: +353 1800 851 868
[email protected]

Slovenija
argenx BV
Tel: +386 (0)80 688 955
[email protected]

Ísland
argenx BV
Sími: +354 800 4422
[email protected]

Slovenská republika
argenx BV
Tel: +421 (0)800 002 646
[email protected]

Italia
argenx Italia s.r.l
Tel: +39 800 729 052
[email protected]

Suomi/Finland
argenx BV
Puh/Tel: +358 (0)800 412 838
[email protected]

Κύπρος
argenx BV
Τηλ: +357 800 77 122
[email protected]

Sverige
argenx BV
Tel: +46 (0)20 12 74 56
[email protected]

Latvija
argenx BV
Tel: +371 80 205 267
[email protected]

Altre fonti d’informazioni
Informazioni più dettagliate su questo medicinale sono disponibili sul sito web dell’Agenzia europea
per i medicinali, https://www.ema.europa.eu . Inoltre, sono riportati link ad altri siti web su malattie
rare e relativi trattamenti terapeutici.
------------------------------------------------------------------------------------------------------------------------

Istruzioni importanti per l’uso
Vyvgart 1 000 mg soluzione iniettabile
efgartigimod alfa
Uso sottocutaneo
Al fine di migliorare la tracciabilità dei medicinali biologici, il nome e il numero di lotto del
medicinale somministrato devono essere chiaramente registrati.
Si accerti di leggere e comprendere queste Istruzioni per l’uso prima di iniettare Vyvgart.
Se lei o la persona che la assiste intende somministrare Vyvgart, riceverà una formazione su come
iniettare Vyvgart da parte del suo operatore sanitario. L’operatore sanitario deve mostrare a lei o alla
persona che la assiste come preparare e iniettare correttamente Vyvgart prima di usare il medicinale
per la prima volta. Si ritiene necessaria una dimostrazione della corretta autosomministrazione sotto la
supervisione di un operatore sanitario. È importante che lei non provi a iniettare il medicinale finché
non avrà ricevuto una formazione adeguata e lei o la persona che la assiste non sarà sicuro/a di aver
capito come usare Vyvgart. Se ha dubbi, si rivolga all’operatore sanitario.

Informazioni importanti che deve conoscere prima di iniettare Vyvgart per via sottocutanea

• Solo per uso sottocutaneo.
• Il flaconcino è esclusivamente monouso. Nonconservare i flaconcini, anche se non sono vuoti.
• Nonutilizzare flaconcini che presentano opacità insolite o particelle visibili. Il medicinale deve avere un aspetto leggermente giallo, da limpido a leggermente torbido.
• Nonagitare il flaconcino durante la manipolazione.
• Nonutilizzare flaconcini danneggiati o privi di cappuccio protettivo. Segnalare e restituire alla farmacia eventuali flaconcini danneggiati o privi di cappuccio.

Conservazione di Vyvgart

• Conservare in frigorifero (2 °C - 8 °C).
• Noncongelare.
• Se necessario, i flaconcini chiusi possono essere conservati a temperatura ambiente (fino a 30 °C) per un massimo di 3 giorni. Dopo la conservazione a temperatura ambiente, i flaconcini chiusi possono essere rimessi in frigorifero. Il tempo totale di conservazione fuori dal frigorifero e a temperatura ambiente non deve superare i 3 giorni.
• Conservare nella confezione originale per proteggere il medicinale dalla luce.
• Conservi questo medicinale fuori dalla vista e dalla portata dei bambini.

Contenuto della confezione
1 flaconcino contenente Vyvgart

Plastic cap
Rubber
stopper
Aluminum
protection

for use

Forniture aggiuntive non incluse
Conservare le forniture aggiuntive a temperatura ambiente in un luogo asciutto
Tamponi imbevuti di alcol

10 mL syringe
Plunger Body

18 gauge transfer needle, length
≥ 38 mm
Cap
Needle
hub
Needle
(inner cap)

Winged infusion set 25 gauge, 30 cm tube, maximum priming volume of 0.4 mL

Sterile gauze

Adhesive bandage

Sharps disposal container

Preparazione delle forniture
Passaggio 1
Rimuovere la confezione di flaconcini dal frigorifero.

Passaggio 2
Rimuovere il flaconcino dalla confezione e controllare che:

• il flaconcino non sia incrinato, rotto, senza il cappuccio protettivo o mostri segni di danneggiamento.
• la data di scadenza non sia stata superata.

Se una qualsiasi delle condizioni di cui sopra non è
soddisfatta, nonprocedere con l’iniezione e segnalare
questa informazione alla farmacia.

Controlla
Passaggio 3
Attendere almeno 15 minuti affinché il flaconcino si
riscaldi naturalmente a temperatura ambiente.
Controllare se il medicinale nel flaconcino è leggermente
giallo, da limpido a leggermente torbido e non presenta
particelle visibili.

• Nontentare di riscaldare il flaconcino in alcun modo se non lasciandolo a temperatura ambiente.
• Nonagitare il flaconcino.

Passaggio 4
Raccogliere tutte le forniture aggiuntive seguenti:

• 2 tamponi imbevuti di alcol
• 1 siringa da 10 mL
• 1 ago di trasferimento calibro 18
• 1 set di infusione con alette calibro 25 x 30 cm
• 1 garza sterile
• 1 cerotto adesivo
• 1 contenitore per lo smaltimento di oggetti taglienti (vedere Passaggio 28) Passaggio 55a.Pulire l’area di lavoro. 5b.Lavarsi le mani con il sapone e asciugarle accuratamente.

Preparazione della siringa
Passaggio 6
Rimuovere il cappuccio protettivo a strappo in plastica dal
flaconcino.
La protezione in alluminio dovrebbe rimanere in sede.

Passaggio 7
Pulire il tappo in gomma con un nuovo tampone imbevuto
di alcol.
Lasciare asciugare all’aria naturalmente per almeno
30 secondi. Nonsoffiare sul tappo in gomma.

Passaggio 8
Rimuovere la siringa e l’ago di trasferimento dalla
confezione. Spingere l’ago di trasferimento sulla siringa e
ruotarlo in senso orario finché non è saldamente collegato
alla siringa.

Push and rotate

Nontoccare la punta della siringa o la parte inferiore
dell’ago per evitare germi e rischio di infezioni.

Passaggio 9
Tirare indietro lentamente lo stantuffo e aspirare tra
6,2 a 6,8 mL di aria nella siringa.

Passaggio 10
10a.Tenere la siringa a livello del mozzo dell’ago, dove la
siringa è collegata all’ago.

10b.Afferrare il cappuccio dell’ago di trasferimento e
toglierlo con cautela, lontano dal corpo.

10c.Posizionare il cappuccio dell’ago di trasferimento su
una superficie pulita e piana.

10b)

• Nongettare il cappuccio. Sarà necessario richiudere e rimuovere l’ago di trasferimento dopo l’uso. Mantenere l’ago sterile:
• Nontoccare l’ago o la punta dell’ago.
• Nonposizionarlo su una superficie dopo aver

10c)
rimosso il cappuccio dell’ago.

Passaggio 11
Tenere il flaconcino in posizione verticale su una superficie
piana e inserire l’ago di trasferimento attraverso il centro
del tappo in gomma disinfettato.

Nonforare il tappo in gomma del flaconcino più di
una volta per evitare perdite.

Passaggio 12
Capovolgere il flaconcino mantenendo al suo interno l’ago
di trasferimento.

Passaggio 13
13a.Assicurarsi che l’ago di trasferimento nel flaconcino
sia rivolto verso l’alto con la punta dell’ago sopra la
soluzione medicinale.

13b.Spingere delicatamente lo stantuffo per iniettare tutta
l’aria dalla siringa nello spazio vuoto sopra la soluzione
medicinale nel flaconcino.

13c.Tenere il dito premuto sullo stantuffo della siringa.

Noniniettare aria nella soluzione medicinale poiché
ciò potrebbe creare bolle d’aria o schiuma.

Passaggio 14
Riempire la siringa come segue:

14a.Tenere il dito premuto sullo stantuffo della siringa
e far scorrere la punta dell’ago di trasferimento nella
soluzione medicinale nel collo del flaconcino (vicino al
cappuccio del flaconcino) in modo che la punta dell’ago
rimanga completamente ricoperta dalla soluzione.

14b.Tirare indietro lentamente lo stantuffo, mantenendo la
punta dell’ago di trasferimento nella soluzione per evitare
bolle d’aria e schiuma all’interno della siringa.

Fill the syringe with the entire contents of the
vial.

14a)

14b)

Step 15
Remove any large air bubbles.

15a.Hold the transfer needle in the vial and
check that there are no large air bubbles
in the syringe.

15b.Remove any large air bubbles by gently tapping
with your fingers on the body of the syringe until
the air bubbles rise to the top
of the syringe.

15c.Move the tip of the transfer needle above the
medicine solution and slowly push the plunger
upward to expel the air bubbles from the syringe.

15d.To remove any residual medicine solution
from the vial, move the tip of the transfer needle back into the solution and slowly
pull back the plunger until the contents of the
vial are completely in the syringe.

15e.Repeat the previous steps until the larger
air bubbles are eliminated.
If you cannot remove all the liquid from the vial,
place the vial in an upright position to reach
the remaining amount.

Step 16
16a.Place the vial in an upright position and remove
the syringe and transfer needle from the vial.

16b.Using one hand, slide the transfer needle into the
cap and push upwards to
cover the needle.

16c.After covering the transfer needle, rotate the
transfer needle cap onto the syringe to secure it
completely.

15c)

15e)

16a)

16b)

16c)

Step 17
17a.Gently pull and rotate the transfer needle counterclockwise to
remove it from the syringe.

17b.Dispose of (discard) the transfer needle in the
sharps disposal container.

17a)

17b)

Preparation for Vyvgart injection

Step 18
18a.Remove the cap from the end of the winged
infusion set.

18b.Push and gently rotate the end of the winged
infusion set clockwise onto the syringe until
it is firmly attached.
The final syringe configuration should match
the figure on the right.

• Do nottouch the tip of the syringe.
• Do notremove the needle cap.

Step 19
19a.Fill the tube of the winged infusion set by
gently pressing the syringe plunger until
it reaches the 5.6 mL mark.
You should see liquid at the end of the needle.

19b.Place the syringe and winged infusion set
connected on a flat, clean surface.

Do notremove the medicine solution in excess
expelled from the infusion set during filling
of the tube.

Step 20
Choose an injection site

• on the abdomen (belly area) at least 5 cm away from the navel

Choose a different injection site with each injection
(rotate the site) to reduce discomfort.
Note:

Do notinject into areas where the skin is red, bruised,
tender, hard, or areas where there are moles or
scars.

Vyvgart Injection

Step 22
22a.Carefully remove the needle cap from the winged
infusion set.

22b.Fold the wings of the winged infusion set upwards and hold them
between your thumb and index finger, with the needle underneath them.
22a)
Note:
To avoid infection, make sure the needle does not come into
contact with anything before insertion into the skin.
22b)

Step 23
With your free hand, pinch a fold of skin around the
disinfected injection site and lift it upwards. Grab
enough skin to create a “tent” into which to
insert the needle.

Do nothold the skin too tightly to avoid bruising.

Step 24
Insert the needle into the center of the pinched skin area at an angle
of approximately 45 degrees.
Note:
The needle should insert easily into the skin. If you
feel some resistance, you can pull the needle back slightly.

Step 25
Check the infusion set. Make sure there is no blood.
Important:
If you notice blood, pull the needle back slightly without removing it from the skin.

Vyvgart Disposal
Step 28
Dispose of (discard) the winged infusion set (with needle and syringe
attached) and the vial in the sharps disposal container.
If you do nothave a sharps disposal container,
you can use a household container if it is:

made of sturdy plastic;
resealable with a tight-fitting, puncture-resistant lid that does not allow sharp objects to
leak out;
upright and stable;
leakproof;
properly labeled with a warning that hazardous waste is inside.
Dispose of the full container according to the instructions of your
healthcare provider or pharmacist.
Note:
Always keep the sharps disposal container out of sight and reach of children.

Vyvgart 1 000 mg injectable solution in pre-filled syringe

efgartigimod alfa

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicine. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of 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

1. What is Vyvgart and what is it used for

What is Vyvgart
Vyvgart contains the active substance efgartigimod alfa. Efgartigimod alfa binds to a protein in the
body called the neonatal Fc receptor (FcRn) and blocks it. By blocking FcRn, efgartigimod alfa
reduces the level of autoantibodies immunoglobulin G (IgG), which are proteins of the immune system
that mistakenly attack certain parts of a person's body.

What is Vyvgart used for
Vyvgart is used together with standard therapy in the treatment of adults with generalized myasthenia gravis
(gMG), an autoimmune disease that causes muscle weakness. Generalized myasthenia gravis can affect multiple
muscle groups throughout the body. The disease can also cause
shortness of breath, extreme fatigue, and difficulty swallowing.
In patients with generalized myasthenia gravis, IgG autoantibodies attack and damage certain
proteins on the nerves called acetylcholine receptors. Due to this damage, the nerves are unable to
cause the muscles to contract effectively, leading to muscle weakness and difficulty
moving. By binding to the FcRn protein and reducing levels of autoantibodies, Vyvgart can
improve the ability of muscles to contract and reduce the symptoms of the disease and their impact on
daily activities.
Vyvgart is also used for the treatment of adults with chronic inflammatory demyelinating
polyneuropathy (CIDP), a form of autoimmune disease. CIDP causes muscle weakness and/or numbness primarily
of the legs and arms. Vyvgart can protect the nerves
from attack and reduce the symptoms of the disease and their impact on daily activities.

2. What you need to know before using Vyvgart

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.
Class V according to the MGFA
Your doctor may not prescribe this medicine if you are undergoing ventilation due to
muscle weakness from gMG (myasthenic crisis).
Infections
Treatment with Vyvgart may reduce natural resistance to infections. Therefore, before starting to
use Vyvgart, tell your doctor if you have any infections.
Injection site reactions and allergic reactions
Vyvgart contains a protein that may cause reactions such as rash or itching in some people. Vyvgart
may cause anaphylaxis (a severe allergic reaction). If allergic reactions appear
such as swelling of the face, lips, throat or tongue that makes it difficult to swallow,
breathe, shortness of breath, feeling of losing consciousness or skin rash during or after
the injection, tell your doctor immediately.
Immunizations (vaccinations)
Tell your doctor if you have received a vaccine in the last 4 weeks, or if you are due to receive a
vaccination soon.

Children and adolescents
Do not give this medicine to children under 18 years of age as the safety and efficacy of
Vyvgart have not been established in this population.

Elderly
No special precautions are necessary for the treatment of patients over 65 years of age.

Other medicines and Vyvgart
Tell your doctor if you are taking, have recently taken or might take any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Vyvgart is not expected to affect your ability to drive or operate machinery.

Vyvgart contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per syringe, i.e. essentially
“sodium-free”.

Vyvgart contains polysorbate
This medicine contains 2.1 mg of polysorbate 80 per syringe equivalent to 0.4 mg/mL. Polysorbates
may cause allergic reactions. Tell your doctor if you have known allergies.

3. How to use Vyvgart

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

What dose of Vyvgart you will receive and how often

Generalized Myasthenia Gravis
The recommended dose is 1,000 mg administered in cycles of one injection per week for
4 weeks. The doctor will determine when further treatment cycles are necessary.
If you are already being treated with Vyvgart intravenously and wish to switch to Vyvgart subcutaneously, you must receive the subcutaneous injection instead of the intravenous infusion at the beginning of the
next treatment cycle.

Chronic Inflammatory Demyelinating Polyneuropathy
The recommended dose is 1,000 mg, one injection per week. Based on how you respond to
treatment, your doctor may change the dose to 1 injection every 2 weeks.

Vyvgart Injection
Vyvgart is administered by injection under the skin (subcutaneous). You and your doctor must
decide whether, after adequate training, you or the person assisting you can inject Vyvgart.
The first self-injection must be performed in the presence of a healthcare professional. It is important not
to attempt to inject Vyvgart before being trained by a healthcare professional.
If you or the person assisting you injects Vyvgart, you must carefully read and follow the Instructions for
Administration at the end of this leaflet (see “Important Instructions for Use”).
For any questions about self-administering an injection, consult your doctor, pharmacist, or
nurse.

If you use more Vyvgart than you should
Because Vyvgart is administered in a single-use prefilled syringe, it is unlikely that you will receive
an excessive amount. However, if you are concerned, consult your doctor, pharmacist, or nurse.

If you miss a dose or forget an appointment for Vyvgart administration
Keep track of your next dose. It is important to use Vyvgart exactly as prescribed by
your doctor.

• If you miss a dose within three days of the scheduled date, you should take it as soon as you remember and then follow the original dosing schedule.
• If you miss a dose for more than three days, ask your doctor when to take the next dose.
• If you forget an appointment, consult your doctor immediately.

Do not take a double dose to make up for a missed dose.

If you stop taking Vyvgart
Stopping or interrupting treatment with Vyvgart may cause your symptoms to return.
Consult your doctor before stopping treatment with Vyvgart. The doctor will discuss with you the
possible side effects and risks. The doctor will also want to monitor you closely.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Before treatment, your doctor will discuss possible side effects with you and explain the risks
and benefits of Vyvgart.

Tell your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue that makes it difficult to swallow or breathe, shortness of breath, feeling of loss
of consciousness or rash during or after the injection.
For any doubt regarding the side effects listed below, ask your doctor for clarification.

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

• upper respiratory tract infections (nose and throat)
• reactions at the injection site, which may include redness, itching and pain. These injection site reactions are usually mild to moderate and usually occur within one day of the injection.

Common(may affect up to 1 in 10 people)

• pain or 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)
• nausea.

Not known(frequency cannot be estimated based on available data)

• allergic reactions during or after the injection:
• swelling of the face, lips, throat or tongue that makes it difficult to swallow or breathe, shortness of breath
• paleness, weak and rapid pulse or feeling of loss of consciousness
• sudden onset of rash, itching or hives.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor. You can also report side effects directly through the national reporting system reported in
Appendix V. By reporting side effects you can help provide
more information on the safety of this medicine.

5. How to store Vyvgart

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 pack 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.
You can also store the unopened pre-filled syringe at room temperature in the original pack
up to a temperature of 30 °C for a single period of up to 1 month after removing it from the
refrigerator. Discard it if it has not been used within the 1-month period or by the expiry date,
whichever occurs first.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice visible particles.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Vyvgart contains

• The active substance is efgartigimod alfa. Each pre-filled syringe contains 1,000 mg of efgartigimod alfa in 5.0 mL. Each mL contains 200 mg of efgartigimod alfa.
• The other ingredients are: recombinant human hyaluronidase (rHuPH20), L-arginine hydrochloride, L-histidine, L-histidine monohydrate hydrochloride, L-methionine, polysorbate 80 (E433), sodium chloride, sucrose, water for injections. See section 2 “Vyvgart contains sodium”.

Description of Vyvgart and contents of the pack
Vyvgart is a ready-to-use solution, slightly yellow in colour, from clear to slightly cloudy, supplied
as a solution for subcutaneous injection in a pre-filled syringe.

Marketing Authorisation Holder and Manufacturer
argenx BV
Industriepark‑Zwijnaarde 7
9052 Gent
Belgium
For further information on this medicine, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
argenx BV
Tél/Tel: +32 (0)9 39 69 394/+32 (0)800 54 477
[email protected]
argenx BV
Tel: +370 (0)800 80 052
[email protected]

България
argenx BV
Тел.: +359 (0)800 46 273
[email protected]

Luxembourg/Luxemburg
argenx BV
Tél/Tel: +352 800 25 233
[email protected]

Česká republika
argenx BV
Tel: +420 800 040 854
[email protected]

Magyarország
argenx BV
Tel.: +36 800 88 578
[email protected]

Danmark
argenx BV
Tlf.: +45 80 25 41 88
[email protected]

Malta
argenx BV
Tel: +356 800 65 101
[email protected]

Deutschland
argenx Germany GmbH
Tel: +49 (0)800 180 3963
[email protected]

Nederland
argenx BV
Tel: +31 (0)800 023 2882
[email protected]

Eesti
argenx BV
Tel: +372 800 010 0919
[email protected]

Norge
argenx BV
Tlf: +47 800 62 225
[email protected]

Ελλάδα
Medison Pharma Greece Single Member Societe
Anonyme
Τηλ: +30 210 0100 188
[email protected]

Österreich
argenx BV
Tel: +43 (0)800 017936
[email protected]

España
argenx Spain S.L.
Tel: +34 900 876 188
[email protected]

Polska
argenx BV
Tel.: +48 800 005 155
[email protected]

France
argenx France SAS
Tél: +33 (0)1 88 89 89 92
[email protected]

Portugal
argenx Spain S.L. Sucursal Em Portugal
Tel: +351 800 180 844
[email protected]

Hrvatska
argenx BV
Tel: +385 (0)800 806 524
[email protected]

România
argenx BV
Tel: +40 (0)800 360 912
[email protected]

Ireland
argenx BV
Tel: +353 1800 851 868
[email protected]

Slovenija
argenx BV
Tel: +386 (0)80 688 955
[email protected]

Ísland
argenx BV
Sími: +354 800 4422
[email protected]

Slovenská republika
argenx BV
Tel: +421 (0)800 002 646
[email protected]

Italia
argenx Italia s.r.l
Tel: +39 800 729 052
[email protected]

Suomi/Finland
argenx BV
Puh/Tel: +358 (0)800 412 838
[email protected]

Κύπρος
argenx BV
Τηλ: +357 800 77 122
[email protected]

Sverige
argenx BV
Tel: +46 (0)20 12 74 56
[email protected]

Latvija
argenx BV
Tel: +371 80 205 267
[email protected]

Other sources of information
More detailed information on this medicine is available on the website of the European Medicines
Agency, https://www.ema.europa.eu. Links to other websites on rare diseases and related therapeutic treatments are also provided.
------------------------------------------------------------------------------------------------------------------------

Important instructions for use
Vyvgart 1,000 mg solution for injection in pre-filled syringe
efgartigimod alfa
Subcutaneous use
In order to improve the traceability of biological medicines, the name and batch number of the
medicine administered must be clearly recorded.
Make sure to read and understand these Instructions for Use before injecting Vyvgart.
If you or the person assisting you intends to administer Vyvgart, you will receive training on how
to inject Vyvgart from your healthcare professional. The healthcare professional must demonstrate to you or
the person assisting you how to prepare and inject Vyvgart correctly before using the medicine
for the first time. A demonstration of correct self-administration under the
supervision of a healthcare professional is considered necessary. It is important that you do not attempt to inject the medicine until
you have received adequate training and you or the person assisting you are confident that you have
understood how to use Vyvgart. If you have any doubts, contact your healthcare professional.

Important information you must know before injecting Vyvgart subcutaneously

• For subcutaneous use only.
• The pre-filled syringe is for single use only and must not be reused.
• Do notuse the pre-filled syringe if it has been stored at room temperature for more than 1 month.
• Do notuse the pre-filled syringe if the expiry date has been passed.
• Do notuse the pre-filled syringe if it is cracked, broken, damaged or if the cap is missing. Report the problem and return these damaged pre-filled syringes to the pharmacy.
• Do notuse the pre-filled syringe if the colour of the medicine has changed or if the medicine contains particles. The medicine should appear from clear to light yellow. A slight cloudiness is normal.
• Do notshake the pre-filled syringe.

Storage of Vyvgart in a pre-filled syringe

• Store in a refrigerator (2 °C - 8 °C).
• Do notfreeze.
• You can also store the unopened pre-filled syringe at room temperature in its original packaging up to a temperature of 30 °C for a single period of up to 1 month after removing it from the refrigerator. Discard it if it has not been used within the 1-month period or by the expiry date, whichever comes first.
• Store in the original packaging to protect the medicine from light.
• Keep this medicine out of the sight and reach of children.

Components of the pre-filled syringe

Gather and check the materials

1. Remove the package from the refrigerator

• 1.1Remove the box of the prefilled syringe from the refrigerator.
• 1.2Remove 1 prefilled syringe from the box and return the remaining prefilled syringes to the refrigerator for subsequent use.
• 1.3Remove the prefilled syringe from the tray.

2. Check the prefilled syringe before

use

• 2.1Check the expiration date on the prefilled syringe.

Do notuse the prefilled syringe if it has
exceeded the expiration date.

• 2.2Check the condition of the prefilled syringe and its cap.

Do notuse the prefilled syringe if it is
cracked, broken, damaged, or if the cap is
missing.

• 2.3Check the appearance of the medicine in the prefilled syringe. The medicine should appear from transparent to light yellow in color. Slight turbidity is normal. Do notuse the prefilled syringe if the color of the medicine is altered or if the medicine contains particles.

Prepare the injection

3. Allow the pre-filled syringe to

warm to room temperature
Place the pre-filled syringe on a
flat, clean surface and let it rest for
at least 30 minutes, so that it reaches
room temperature.

Do notattempt to warm the pre-filled syringe
in any other way.

Do notuse the pre-filled syringe if it has
been stored at room temperature
for more than 1 month.

4. Gather the materials and wash your hands

• 4.1Gather the following materials notsupplied with the prefilled syringe.
• 4.2Wash your hands with water and soap.

5. Remove the syringe cap

prefilled and attach the needle

• 5.1Carefully open the package and remove the needle. Dispose of the packaging in household waste.

• 5.2Bend the cap of the prefilled syringe to one side to detach it and remove it from the prefilled syringe. Dispose of the syringe cap in household waste and place the prefilled syringe on a clean, flat surface.

Do nottouch the tip of the prefilled syringe
after removing the cap.

• 5.3With the prefilled syringe in one hand, apply the needle by rotating it (clockwise/to the right) until resistance is felt.

Now the needle is attached to the prefilled syringe.

6. Choose and clean the injection site

on the abdomen

• 6.1Choose an injection site on the abdomen (belly area) at least 5 cm away from the navel. Change the site with each injection.

Do notinject into areas with
irritated, reddened, bruised, infected
or scarred skin. Do notinject
into a vein. The prefilled syringe is
intended exclusively for subcutaneous
injection.

• 6.2Clean the chosen injection site with a cotton ball soaked in alcohol and let it air dry.

Do notblow on or touch the injection
site after it has been cleaned.

Inject Vyvgart

7. Pull back the needle shield

and remove the cap

• 7.1Pull back the needle shield.

Note:the needle shield will be
used after the injection to
cover the needle and avoid any
accidental punctures.

• 7.2Hold the body of the prefilled syringe and remove the transparent needle cap with a straight motion. Dispose of the needle cap in household waste.

Do notreplace the cap
on the needle.

8. Perform the injection

• 8.1Pinch the clean injection site. While keeping the skin pinched, insert the needle at an angle between 45 and 90 degrees. Then release the pinched skin.

Do notpinch the skin too
firmly to avoid
bruising.

• 8.2To inject the medicine, slowly press the plunger until it stops. It takes about 20-30 seconds to inject all of the medicine. You will feel some resistance when pressing down. If you experience discomfort, inject more slowly.

If necessary, you can take a
break or change your grip during
the injection.

Do nottry to force the
plunger down quickly as this will increase
resistance.

• 8.3After injecting all of the liquid medicine, withdraw the needle from the skin in a straight line without changing the angle.

Dispose of the used syringe

9. Cover the needle and dispose of the used syringe

• 9.1Carefully push the needle shield onto the needle until it clicks into place and covers the needle itself. This helps to prevent accidental punctures.

Do notreplace the needle cap;
use only the needle shield
to cover it.

• 9.2Immediately after use, dispose of the used syringe, with the needle still inserted, in a sharps container.

Do notthrow away (dispose of) needles and
syringes loosely in household waste.
If you do nothave a sharps disposal container, you can
use a household container if it is:
made of sturdy plastic;
resealable with a tight-fitting, leak-proof lid and
puncture-resistant, preventing sharp objects from
protruding;
upright and stable;
leak-proof;

appropriately labeled with a warning that the container contains hazardous waste. Dispose of the full container according to the instructions of your doctor, nurse, or pharmacist.	c o
10. Treat the injection site If a small amount of blood or fluid is present at the injection site, hold a gauze pad firmly until the bleeding stops. If necessary, you can apply a small adhesive bandage.	a r m a