Vyvgart

Patient Information Leaflet

Vyvgart 20 mg/mL concentrate for solution for infusion

efgartigimod alfa
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because 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 give it to other people, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, 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 using 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 Vyvgart is and what it is used for

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

What Vyvgart is used for
Vyvgart is used in combination with standard therapy for 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 nerves called acetylcholine receptors. Due to this damage, nerves are unable to stimulate muscle contraction effectively, resulting in muscle weakness and difficulty with movement. By binding to the FcRn protein and reducing levels of autoantibodies, Vyvgart may improve the muscles' ability to contract and reduce disease symptoms 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.
MGFA Class V
Your doctor may not prescribe this medicine if you are on ventilation due to muscle weakness from gMG (myasthenic crisis).

Infections
Treatment with Vyvgart 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 may cause reactions such as rash or itching in some people. Vyvgart may cause an anaphylactic reaction (a severe allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or skin rash during or after the infusion, inform your doctor immediately.
You will be monitored for signs of infusion reactions or allergic reactions during and for 1 hour after treatment.

Immunizations (vaccinations)
Inform your doctor if you have received a vaccine within 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 required for treatment of patients aged 65 years and older.

Other medicines and Vyvgart
Inform your doctor if you are currently using, have recently used, or might use any other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Vyvgart is not expected to affect the ability to drive vehicles or operate machinery.

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

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. Inform your doctor if you have known allergies.

3. How to use Vyvgart

Vyvgart will be administered to you by a doctor or other healthcare professional. The healthcare provider will first dilute the product. The diluted solution will then be given through an intravenous infusion bag via a tube directly into a vein over a period of 1 hour.

What dose of Vyvgart will you receive and how often
The dose you will receive depends on your body weight and will be administered in cycles of one infusion per week for 4 weeks. Your doctor will determine when additional treatment cycles are needed.
Instructions for healthcare providers on the correct 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 accidentally received a higher dose of Vyvgart than prescribed, consult your doctor.

If you miss an appointment for administration of Vyvgart
If you miss an appointment, contact your doctor immediately and refer to the next section “If you interrupt treatment with Vyvgart”.

If you interrupt treatment with Vyvgart
Stopping or interrupting treatment with Vyvgart may cause the return of generalized myasthenia gravis symptoms. Consult your doctor before discontinuing treatment with Vyvgart. Your doctor will discuss with you the potential side effects and risks, and may wish to monitor you closely.

If you have any questions about the use of this medicine, speak to your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Before treatment, your doctor will discuss with you the possible side effects and explain the risks and benefits of Vyvgart.
Inform your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or a rash during or after the infusion.

For any questions regarding the side effects listed below, please ask your doctor for clarification.

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

• Infections of the nose and throat (upper respiratory tract infections)

Common (may affect up to 1 in 10 people)

• Pain or burning sensation when urinating, which may be a sign of urinary tract infection
• Inflammation of the airways in the lungs (bronchitis)
• Muscle pain (myalgia)
• Headache during or after administration of Vyvgart
• Nausea

Not known (frequency cannot be estimated from the available data)

• Allergic reactions during or after infusion:
• Swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath
• Pallor, weak and rapid pulse or feeling faint
• Sudden onset of rash, itching or hives

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via 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 stated on the carton 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.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you notice visible particles and/or if the colour of the liquid in the vial has changed.
The product must be used immediately after dilution and the infusion must be completed within 4 hours of dilution. Allow 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Vyvgart contains
The active substance is efgartigimod alfa.

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

Description of the appearance of Vyvgart and contents of the pack
Vyvgart is a sterile concentrate for intravenous (i.v.) infusion (20 mL in a vial – pack of 1 vial).
Vyvgart is a liquid. It is colourless or 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
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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

България Luxembourg/Luxemburg
argenx BV argenx BV
Teл.: +359 (0)800 46 273 Tél/Tel: +352 800 25 233
[email protected] [email protected]

Česká republika Magyarország
argenx BV argenx BV
Tel: +420 800 040 854 Tel.: +36 800 88 578
[email protected] [email protected]

Danmark Malta
argenx BV argenx BV
Tlf.: +45 80 25 41 88 Tel: +356 800 65 101
[email protected] [email protected]

Deutschland Nederland
argenx Germany GmbH argenx BV
Tel: +49 (0)800 180 3963 Tel: +31 (0)800 023 2882
[email protected] [email protected]

Eesti Norge
argenx BV argenx BV
Tel: +372 800 010 0919 Tlf: +47 800 62 225
[email protected] [email protected]

Ελλάδα Österreich
Medison Pharma Greece Single Member argenx BV
Societe Anonyme Tel: +43 (0)800 017936
Τηλ: +30 210 0100 188 [email protected]
[email protected]

España Polska
argenx Spain S.L. argenx BV
Tel: +34 900 876 188 Tel.: +48 800 005 155
[email protected] [email protected]

France Portugal
argenx France SAS argenx Spain S.L. Sucursal Em Portugal
Tél: +33 (0)1 88 89 89 92 Tel: +351 800 180 844
[email protected] [email protected]

Hrvatska România
argenx BV argenx BV
Tel: +385 (0)800 806 524 Tel: +40 (0)800 360 912
[email protected] [email protected]

Ireland Slovenija
argenx BV argenx BV
Tel: +353 1800 851 868 Tel: +386 (0)80 688 955
[email protected] [email protected]

Ísland Slovenská republika
argenx BV argenx BV
Sími: +354 800 4422 Tel: +421 (0)800 002 646
[email protected] [email protected]

Italia Suomi/Finland
argenx Italia s.r.l argenx BV
Tel: +39 800 729 052 Puh/Tel: +358 (0)800 412 838
[email protected] [email protected]

Κύπρος Sverige
argenx BV argenx BV
Τηλ: +357 800 77 122 Tel: +46 (0)20 12 74 56
[email protected] [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 website of the European Medicines Agency: https://www.ema.europa.eu. Additionally, links to other websites on rare diseases and related therapeutic treatments are provided.

The following information is intended exclusively for healthcare professionals:

Instructions for use for healthcare professionals handling Vyvgart

Vyvgart is a ready-to-use solution for intravenous infusion. No preparation is required before administration.

Administration

Vyvgart must be administered by intravenous infusion only.

• The solution must be administered using a sterile, non-pyrogenic, non-protein binding, low protein binding infusion set equipped with an in-line, low protein binding, 0.2 µm filter.
• Do not mix Vyvgart with other medicinal products.
• The product must not be administered as an intravenous push or bolus injection.
• Vyvgart must be administered through a dedicated line. If a separate line is not available, the line may be flushed before and after infusion with 0.9% sodium chloride solution.
• The infusion line must be flushed after the infusion with 0.9% sodium chloride solution.

Infusion Duration

• The recommended infusion duration is 1 hour.
• If the patient tolerates the first infusion well, subsequent infusions may be administered over a shorter duration of 30 minutes.
• If the patient experiences infusion-related reactions, the infusion rate may be reduced or stopped.

Dosage

The recommended dosage regimen is as follows:

• Initial dose: 10 mg/kg body weight administered once weekly for 4 weeks.
• Maintenance dose: 10 mg/kg body weight administered every 4 weeks.

Monitoring

• Monitor patients during and after infusion for signs and symptoms of infusion-related reactions.
• Pre-medication may be considered to reduce the risk of infusion-related reactions.

Storage

• Store in the refrigerator (2°C – 8°C).
• Protect from light.
• Do not freeze.
• Do not shake.

Disposal

Dispose of unused product and waste materials in accordance with local requirements.

For full details, refer to the Summary of Product Characteristics.

1. How is Vyvgart supplied?

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

2. Before administration

Reconstitution and dilution must be performed in accordance with good practice standards,
particularly maintaining aseptic conditions.
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 required 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 based on a body weight of 120 kg. The maximum total dose for infusion is 1,200 mg. Each vial contains 400 mg of efgartigimod alfa at a concentration of 20 mg/mL.
• The number of vials required.
• The volume of 9 mg/mL (0.9%) sodium chloride injection solution. The total volume of diluted medicinal product 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 solution in the vial for clarity. The solution should be clear to slightly opalescent, colorless to slightly yellow, and free of particulate matter. If visible particles are observed and/or if discoloration of the liquid in the vial is noted, discard the vial. Do not shake the vials.
• Using aseptic technique throughout the 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 product into an infusion bag.
  • Dilute the withdrawn product by adding the calculated amount of 9 mg/mL (0.9%) sodium chloride injection solution to achieve a total volume of 125 mL.
• Gently invert the infusion bag containing the diluted product without shaking to ensure adequate mixing of product and diluent.
  • The diluted efgartigimod alfa solution in 9 mg/mL (0.9%) sodium chloride injection solution may be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), and ethylene/propylene copolymer (polyolefin bags), as well as with PE, PVC, and polyurethane/polypropylene infusion lines, together with polyurethane (PUR) or PVC filters, with filter membrane made of polyethersulfone (PES) or polyvinylidene fluoride (PVDF).

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 prior to administration.
• Infuse the total volume of 125 mL of diluted medication over 1 hour using a 0.2 µm filter. Administer the entire amount of solution. After administration of the product, flush the line with 9 mg/mL (0.9%) sodium chloride injection solution.
• Administer immediately after dilution and complete the infusion of the diluted solution within 4 hours of dilution.
• Chemical and physical stability during use has been demonstrated for 24 hours at 2 °C – 8 °C. From a microbiological standpoint, unless the dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the times and conditions of storage during use are the responsibility of the user. Do not freeze. Allow the diluted medication to reach room temperature before administration. Complete the infusion within 4 hours after removal from the refrigerator. The diluted medication must be warmed exclusively to room temperature.
• If infusion-related reactions occur, the infusion rate should be reduced, or the infusion interrupted or suspended.
• Do not inject other medicinal products into the side ports of the infusion line nor mix them with Vyvgart.

4. Special handling and storage instructions

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

Package leaflet: information for the patient

Vyvgart 1000 mg solution for injection

efgartigimod alfa
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact 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 using 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 Vyvgart is and what it is used for

What Vyvgart is
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 levels of immunoglobulin G (IgG) autoantibodies, which are immune system proteins that mistakenly attack certain parts of a person's body.

What Vyvgart is used for
Vyvgart is used together with standard therapy for the treatment of adults with generalized myasthenia gravis (gMG), an autoimmune disease causing muscle weakness. Generalized myasthenia gravis can affect multiple muscle groups throughout the body. The disease may also cause shortness of breath, extreme fatigue, and difficulty swallowing.

In patients with generalized myasthenia gravis, IgG autoantibodies attack and damage certain proteins on nerves called acetylcholine receptors. Due to this damage, nerves are unable to stimulate muscle contraction effectively, resulting in muscle weakness and movement difficulties. By binding to the FcRn protein and reducing levels of autoantibodies, Vyvgart can improve the muscles' ability to contract and reduce disease symptoms 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 in the legs and arms. Vyvgart may protect nerves from attack and reduce disease symptoms 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 may cause allergic reactions. Inform your doctor if you have 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.
MGFA Class V
Your doctor may not prescribe this medicine if you are on ventilation due to muscle weakness from gMG (myasthenic crisis).
Infections
Treatment with Vyvgart may reduce your natural resistance to infections. Therefore, before starting Vyvgart, inform your doctor if you have any infections.
Injection reactions and allergic reactions
Vyvgart contains a protein that may cause reactions such as rash or itching in some people. Vyvgart may cause an anaphylactic reaction (a severe allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or skin rash during or after the injection, inform your doctor immediately.
Immunizations (vaccinations)
Inform your doctor if you have received a vaccine within 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 required for treatment of patients over 65 years of age.
Other medicines and Vyvgart
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Vyvgart is not expected to have an effect on the ability to drive or 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 exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

What dose of Vyvgart will you receive and how often

Generalized myasthenia gravis
The recommended dose is 1,000 mg administered in cycles consisting of one weekly injection for 4 weeks. Your doctor will determine when further treatment cycles are needed.
If you are already being treated with intravenous Vyvgart and wish to switch to subcutaneous Vyvgart, you should receive the subcutaneous injection instead of the intravenous infusion at the beginning of your next treatment cycle.

Chronic inflammatory demyelinating polyneuropathy
The recommended dose is 1,000 mg, one injection per week. Depending on your response to treatment, your doctor may adjust the dose to one injection every two weeks.

Vyvgart injection
Vyvgart is administered by injection under the skin (subcutaneously). You and your doctor must decide whether, after adequate training, you or your caregiver may administer Vyvgart injections.
The first self-injection must be performed under the supervision of a healthcare professional. It is important not to attempt to inject Vyvgart before being properly trained by a healthcare professional.
If you or your caregiver will be administering Vyvgart injections, you must carefully read and follow the Instructions for Administration provided 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
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, take it as soon as you remember, then continue with 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 miss an appointment, contact your doctor immediately.

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Before starting treatment, your doctor will discuss the possible side effects with you and explain the risks and benefits of Vyvgart.
Contact your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or skin rash during or after the injection.

If you have any doubts about the side effects listed below, please ask your doctor for clarification.

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

• Infections of the nose and throat (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 typically occur within one day after the injection.

Common (may affect up to 1 in 10 people)

• Pain or burning sensation when urinating, 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 from the available data)

• Allergic reactions during or after the injection:
  • Swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath
  • Pallor, weak and rapid pulse or feeling faint
  • Sudden onset of skin rash, itching or hives

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

5. How to store 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 carton and label after
"Exp.". The expiry date refers to the last day of that month.
Store in the refrigerator (2 °C - 8 °C). Do not freeze.
If necessary, unopened vials may be stored at room temperature (up to 30 °C) for
a maximum of 3 days. After storage at room temperature, unopened vials may
be returned to the refrigerator. The total time outside the refrigerator and at room temperature must not
exceed 3 days.
Keep 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 via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Vyvgart contains

• The active substance is efgartigimod alfa. Each vial contains 1,000 mg of efgartigimod alfa in 5.6 mL. Each mL contains 180 mg of efgartigimod alfa.
• The other components are: recombinant human hyaluronidase (rHuPH20), L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 20 (E432), sodium chloride, sucrose, water for injections. See section 2 “Vyvgart contains sodium”.

Description of the appearance of Vyvgart and contents of the pack
Vyvgart is a ready-to-use, slightly yellow, from clear to slightly cloudy solution, supplied as a solution for subcutaneous injection.
Marketing Authorisation Holder and Manufacturer
argenx BV
Industriepark-Zwijnaarde 7
9052 Gent
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
argenx BV argenx BV
Tél/Tel: +32 (0)9 39 69 394/+32 (0)800 54 477 Tel: +370 (0)800 80 052
[email protected] [email protected]
България Luxembourg/Luxemburg
argenx BV argenx BV
Teл.: +359 (0)800 46 273 Tél/Tel: +352 800 25 233
[email protected] [email protected]
Česká republika Magyarország
argenx BV argenx BV
Tel: +420 800 040 854 Tel.: +36 800 88 578
[email protected] [email protected]
Danmark Malta
argenx BV argenx BV
Tlf.: +45 80 25 41 88 Tel: +356 800 65 101
[email protected] [email protected]
Deutschland Nederland
argenx Germany GmbH argenx BV
Tel: +49 (0)800 180 3963 Tel: +31 (0)800 023 2882
[email protected] [email protected]
Eesti Norge
argenx BV argenx BV
Tel: +372 800 010 0919 Tlf: +47 800 62 225
[email protected] [email protected]
Ελλάδα Österreich
Medison Pharma Greece Single Member Societe argenx BV
Anonyme Tel: +43 (0)800 017936
Τηλ: +30 210 0100 188 [email protected]
[email protected]
España Polska
argenx Spain S.L. argenx BV
Tel: +34 900 876 188 Tel.: +48 800 005 155
[email protected] [email protected]
France Portugal
argenx France SAS argenx Spain S.L. Sucursal Em Portugal
Tél: +33 (0)1 88 89 89 92 Tel: +351 800 180 844
[email protected] [email protected]
Hrvatska România
argenx BV argenx BV
Tel: +385 (0)800 806 524 Tel: +40 (0)800 360 912
[email protected] [email protected]
Ireland Slovenija
argenx BV argenx BV
Tel: +353 1800 851 868 Tel: +386 (0)80 688 955
[email protected] [email protected]
Ísland Slovenská republika
argenx BV argenx BV
Sími: +354 800 4422 Tel: +421 (0)800 002 646
[email protected] [email protected]
Italia Suomi/Finland
argenx Italia s.r.l argenx BV
Tel: +39 800 729 052 Puh/Tel: +358 (0)800 412 838
[email protected] [email protected]
Κύπρος Sverige
argenx BV argenx BV
Τηλ: +357 800 77 122 Tel: +46 (0)20 12 74 56
[email protected] [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 website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.

---

Important instructions for use
Vyvgart 1,000 mg injectable solution
efgartigimod alfa
Subcutaneous use
To improve the traceability of biological medicinal products, the name and batch number of the administered product must be clearly recorded.
Please ensure you 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 from your healthcare provider on how to inject Vyvgart. Your healthcare provider must demonstrate to you or the person assisting you how to properly prepare and inject Vyvgart before using the medicine for the first time. A demonstration of correct self-administration under the supervision of a healthcare provider 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 feel confident in understanding how to use Vyvgart. If you have any doubts, consult your healthcare provider.
Important information you should know before injecting Vyvgart subcutaneously

• For subcutaneous use only.
• The vial is for single use only. Do not store vials, even if they are not empty.
• Do not use vials that appear unusually cloudy or contain visible particles. The medicine should appear slightly yellow, from clear to slightly cloudy.
• Do not shake the vial during handling.
• Do not use vials that are damaged or missing the protective cap. Report and return any damaged vials or vials without a protective cap to the pharmacy.

Storage of Vyvgart

• Store in the refrigerator (2 °C - 8 °C).
• Do not freeze.
• If necessary, unopened vials may be stored at room temperature (up to 30 °C) for a maximum of 3 days. After storage at room temperature, unopened vials may be returned to the refrigerator. The total time stored outside the refrigerator at room temperature must not exceed 3 days.
• Keep in the original packaging to protect from light.
• Keep this medicine out of the sight and reach of children.

Contents of the pack

1 vial containing Vyvgart
Plastic cap
Rubber stopper
Aluminum seal

Vyvgart package leaflet and instructions
for use
Additional supplies not included
Store additional supplies at room temperature in a dry place
Alcohol-impregnated swabs

10 mL syringe
Plunger Barrel

18-gauge transfer needle, length ≥ 38 mm
Needle hub Needle
(capsule cap)

Infusion set with wings, 25-gauge, 30 cm tubing, maximum priming volume 0.4 mL

Sterile gauze

Adhesive plaster

Sharps disposal container
Preparation of supplies
Step 1
Remove the vial packaging from the refrigerator.
Step 2

Remove the vial from the packaging and check that:

• the vial is not cracked, broken, missing the protective cap, or shows signs of damage.
• the expiry date has not been exceeded. Check If any of the above conditions are not met, do not proceed with the injection and report this to the pharmacy.

Step 3

Wait at least 15 minutes for the vial to warm naturally to room temperature.
Check that the medicine in the vial is slightly yellow, from clear to slightly cloudy, and does not contain visible particles.

• Do not attempt to warm the vial in any way other than leaving it at room temperature.
• Do not shake the vial.

Step 4
Gather all the following additional supplies:

• 2 alcohol-impregnated swabs
• 1 10 mL syringe
• 1 18-gauge transfer needle
• 1 infusion set with wings, 25-gauge x 30 cm
• 1 sterile gauze
• 1 adhesive plaster
• 1 sharps disposal container (see Step 28)
  Step 5
  5a. Clean the work area.
  5b. Wash your hands with soap and dry them thoroughly.

Preparing the syringe
Step 6

Remove the plastic pull-off cap from the vial.
The aluminum seal should remain in place.
Step 7
Clean the rubber stopper with a new alcohol-impregnated swab.
Allow to air dry naturally for at least 30 seconds. Do not blow on the rubber stopper.
Step 8

Push and rotate
Remove the syringe and transfer needle from their packaging. Push the transfer needle onto the syringe and rotate clockwise until securely attached.
Do not touch the tip of the syringe or the lower part of the needle to avoid contamination and risk of infection.

Step 9
Slowly pull back the plunger and draw between 6.2 and 6.8 mL of air into the syringe.
Step 10

10a. Hold the syringe at the hub of the needle, where the syringe is attached to the needle.
10b. Grasp the cap of the transfer needle and carefully remove it away from the body.
10c. Place the cap of the transfer needle on a clean, flat surface.

• Do not discard the cap. It will be needed to cover and remove the transfer needle after use. Keep the needle sterile:

10c)

• Do not touch the needle or the tip of the needle.
• Do not place it on a surface after removing the needle cap.

Step 11
Hold the vial upright on a flat surface and insert the transfer needle through the center of the disinfected rubber stopper.
Do not pierce the rubber stopper of the vial more than once to avoid leakage.

Step 12
Invert the vial, keeping the transfer needle inside.
Step 13

13a. Ensure the transfer needle in the vial is pointing upwards, with the needle tip above the medicinal solution.
13b. Gently push the plunger to inject all the air from the syringe into the headspace above the medicinal solution in the vial.
13c. Keep your finger pressed on the syringe plunger.
Do not inject air into the medicinal solution, as this could create air bubbles or foam.
Step 14

Fill the syringe as follows:
14a)
14a. Keep your finger pressed on the syringe plunger and slide the tip of the transfer needle into the medicinal solution in the neck of the vial (near the vial cap), so that the needle tip remains fully submerged in the solution.
14b. Slowly pull back the plunger, keeping the tip of the transfer needle in the solution to avoid air bubbles and foam inside the syringe.
Fill the syringe with the entire content of the
vial.

Step 15
Remove any large air bubbles.
15c)
15a. Keep 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 barrel of the syringe until the bubbles rise to the top of the syringe.
15c. Move the tip of the transfer needle above the medicinal solution and slowly push the plunger upward to expel the air bubbles from the syringe.
15d. To remove any residual medicinal solution from the vial, move the tip of the transfer needle back into the solution and slowly pull back the plunger until the entire content of the vial is in the syringe.
15e. Repeat the previous steps until the larger air bubbles are eliminated.
If not all liquid can be removed from the vial, hold the vial upright to access the remaining amount.

Step 16
16a. Hold the vial upright and remove the syringe and transfer needle from the vial.
16b. Using one hand, slide the transfer needle into the cap and push upward to cover the needle.
16c. After covering the transfer needle, rotate the transfer needle cap onto the syringe to secure it completely.
16b)
16c)

Step 17
17a)
17a. Gently pull and rotate the transfer needle counterclockwise to remove it from the syringe.
17b. Dispose of the transfer needle in the sharps disposal container.
17b)
Preparation for injection of Vyvgart

Step 18
18a. Remove the cap from the end of the winged infusion set.
18b. Gently push and rotate the end of the winged infusion set clockwise onto the syringe until securely attached.
The final syringe configuration should match the figure on the right.

• Do not touch the tip of the syringe.
• Do not remove the needle cap.

Step 19
19a. Fill the tubing of the winged infusion set by gently pushing the syringe plunger until it reaches the 5.6 mL mark. Liquid should be visible at the needle tip.
19b. Place the syringe and attached winged infusion set on a clean, flat surface.
Do not discard the excess medicinal solution expelled from the infusion set during tubing priming.
Step 20

Choose an injection site

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

Choose a different injection site for each injection (rotate sites) to reduce discomfort.
Note:
Do not inject in areas where the skin is red, bruised, tender, hard, or where moles or scars are present.

Vyvgart Injection

Step 22
22a. Carefully remove the needle cap from the winged infusion set for 22a)
infusion.
22b. Bend the wings of the infusion set upward and hold them
between your thumb and index finger, with the needle beneath them.
Note:
To avoid infection, ensure the needle does not touch 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 upward. Grasp enough skin to create a “tent” for needle insertion.
Do not stretch 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 smoothly into the skin. If you feel resistance, you may gently pull the needle back slightly.

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

Disposal of Vyvgart
Step 28

Dispose of the winged infusion set (with attached needle and syringe) and the vial into a sharps disposal container.
If a sharps disposal container is not available, a household container may be used provided that it is:
made of heavy-duty plastic;
closable with a tight-fitting, puncture-resistant lid, without any leakage or protrusion of sharp objects;
upright and stable;
leak-resistant;
clearly labeled to indicate that hazardous waste is inside.
Dispose of the full container according to instructions provided by your healthcare provider or pharmacist.
Note:
Always keep the sharps disposal container out of sight and reach of children.

Patient information leaflet

Vyvgart 1,000 mg solution for injection in pre-filled syringe

efgartigimod alfa
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before using this medicine because 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 using 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 Vyvgart is and what it is used for

What Vyvgart is
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 levels of immunoglobulin G (IgG) autoantibodies, which are immune system proteins that mistakenly attack certain parts of a person's body.

What Vyvgart is used for
Vyvgart is used in combination with standard therapy for 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 may also cause shortness of breath, extreme fatigue, and difficulty swallowing.

In patients with generalized myasthenia gravis, IgG autoantibodies attack and damage certain proteins on nerves called acetylcholine receptors. Due to this damage, nerves are unable to make muscles contract as effectively as normal, resulting in muscle weakness and difficulty moving. By binding to the FcRn protein and reducing levels of autoantibodies, Vyvgart can improve the muscles' ability to contract and reduce disease symptoms 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 in the legs and arms. Vyvgart may protect nerves from attack and reduce disease symptoms 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.
MGFA Class V
Your doctor may decide not to prescribe this medicine if you are undergoing ventilation due to muscle weakness from gMG (myasthenic crisis).
Infections
Treatment with Vyvgart 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 may cause reactions such as rash or itching in some people. Vyvgart may cause an anaphylactic reaction (a severe allergic reaction). If allergic reactions occur, such as swelling of the face, lips, throat, or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint, or skin rash during or after the infusion, inform your doctor immediately.
Immunizations (vaccinations)
Inform your doctor if you have received a vaccine within 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 required for treating patients over 65 years of age.
Other medicines and Vyvgart
Inform 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, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
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., it is 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. Inform your doctor if you have known allergies.

3. How to use Vyvgart

Use this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.

What dose of Vyvgart will you receive and how often

Generalized myasthenia gravis
The recommended dose is 1,000 mg administered in cycles of one weekly injection for 4 weeks. Your doctor will determine when further treatment cycles are needed.
If you are already being treated with intravenous Vyvgart and wish to switch to subcutaneous Vyvgart, you should receive the subcutaneous injection instead of the intravenous infusion at the beginning of your next treatment cycle.

Chronic inflammatory demyelinating polyneuropathy
The recommended dose is 1,000 mg, one injection per week. Depending on your response to treatment, your doctor may adjust the dose to one injection every 2 weeks.

Vyvgart injection
Vyvgart is administered by injection under the skin (subcutaneously). You and your doctor must decide whether, after adequate training, you or your caregiver may inject Vyvgart.
The first self-injection must be performed under the supervision of a healthcare professional. It is important not to attempt to inject Vyvgart before being trained by a healthcare professional.
If you or your caregiver will be injecting Vyvgart, you must carefully read and follow the Instructions for Administration provided at the end of this leaflet (see “Important instructions for use”).
For any questions regarding self-administration of the injection, consult your doctor, pharmacist, or nurse.

If you use more Vyvgart than you should
Since 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 administration of Vyvgart
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, then continue with your 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, contact your doctor immediately.

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

If you stop treatment with Vyvgart
Stopping or interrupting treatment with Vyvgart may cause symptoms to return.
Consult your doctor before stopping treatment with Vyvgart. Your doctor will discuss potential side effects and risks with you and may wish to monitor you closely.

If you have any questions 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 with you the possible side effects and explain the risks and benefits of Vyvgart.
Contact your doctor immediately if you notice:
signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue making it difficult to swallow or breathe, shortness of breath, feeling faint or a skin rash during or after the injection.
If you have any doubts about the side effects listed below, please ask your doctor for clarification.

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

• infections of the nose and throat (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 generally occur within one day of the injection.

Common (may affect up to 1 in 10 people)

• pain or burning sensation when urinating, 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 from the available data)

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. Reporting side effects 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 stated on the carton 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.
The unopened pre-filled syringe may also be stored at room temperature in the original carton, up to a maximum temperature of 30 °C, for a single period of up to 1 month after removal from the refrigerator. Dispose of it if it has not been used within this 1-month period or by the expiry date, whichever comes first.
Keep in the original packaging to protect the medicine from light.
Do not use this medicine if you see visible particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents 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 components are: recombinant human hyaluronidase (rHuPH20), L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sodium chloride, sucrose, water for injections. See section 2 “Vyvgart contains sodium”.

Description of the appearance of Vyvgart and contents of the pack
Vyvgart is a ready-to-use solution, slightly yellow, from clear to slightly cloudy, supplied as a solution for subcutaneous injection in a pre-filled syringe.
Marketing Authorization Holder and Manufacturer
argenx BV
Industriepark-Zwijnaarde 7
9052 Ghent
Belgium
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
argenx BV argenx BV
Tél/Tel: +32 (0)9 39 69 394/+32 (0)800 54 477 Tel: +370 (0)800 80 052
[email protected] [email protected]
България Luxembourg/Luxemburg
argenx BV argenx BV
Teл.: +359 (0)800 46 273 Tél/Tel: +352 800 25 233
[email protected] [email protected]
Česká republika Magyarország
argenx BV argenx BV
Tel: +420 800 040 854 Tel.: +36 800 88 578
[email protected] [email protected]
Danmark Malta
argenx BV argenx BV
Tlf.: +45 80 25 41 88 Tel: +356 800 65 101
[email protected] [email protected]
Deutschland Nederland
argenx Germany GmbH argenx BV
Tel: +49 (0)800 180 3963 Tel: +31 (0)800 023 2882
[email protected] [email protected]
Eesti Norge
argenx BV argenx BV
Tel: +372 800 010 0919 Tlf: +47 800 62 225
[email protected] [email protected]
Ελλάδα Österreich
Medison Pharma Greece Single Member Societe argenx BV
Anonyme Tel: +43 (0)800 017936
Τηλ: +30 210 0100 188 [email protected]
[email protected]
España Polska
argenx Spain S.L. argenx BV
Tel: +34 900 876 188 Tel.: +48 800 005 155
[email protected] [email protected]
France Portugal
argenx France SAS argenx Spain S.L. Sucursal Em Portugal
Tél: +33 (0)1 88 89 89 92 Tel: +351 800 180 844
[email protected] [email protected]
Hrvatska România
argenx BV argenx BV
Tel: +385 (0)800 806 524 Tel: +40 (0)800 360 912
[email protected] [email protected]
Ireland Slovenija
argenx BV argenx BV
Tel: +353 1800 851 868 Tel: +386 (0)80 688 955
[email protected] [email protected]
Ísland Slovenská republika
argenx BV argenx BV
Sími: +354 800 4422 Tel: +421 (0)800 002 646
[email protected] [email protected]
Italia Suomi/Finland
argenx Italia s.r.l argenx BV
Tel: +39 800 729 052 Puh/Tel: +358 (0)800 412 838
[email protected] [email protected]
Κύπρος Sverige
argenx BV argenx BV
Τηλ: +357 800 77 122 Tel: +46 (0)20 12 74 56
[email protected] [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 website of the European Medicines Agency, https://www.ema.europa.eu. In addition, links to other websites on rare diseases and related therapeutic treatments are provided.

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Important instructions for use
Vyvgart 1,000 mg injectable solution in pre-filled syringe
efgartigimod alfa
For subcutaneous use
To improve the traceability of biological medicinal products, the name and batch number of the administered medicine 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 from your healthcare provider on how to inject Vyvgart. Your healthcare provider must demonstrate to you or the person assisting you how to properly prepare and inject Vyvgart before using the medicine for the first time. A demonstration of correct self-administration under the supervision of a healthcare provider 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 in understanding how to use Vyvgart. If you have any doubts, consult your healthcare provider.
Important information you need to know before injecting Vyvgart subcutaneously

• For subcutaneous use only.
• The pre-filled syringe is for single use only and must not be reused.
• Do not use the pre-filled syringe if it has been stored at room temperature for more than 1 month.
• Do not use the pre-filled syringe if the expiry date has been exceeded.
• Do not use 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 not use the pre-filled syringe if the colour of the medicine has changed or if the medicine contains particles. The medicine should appear clear to slightly yellow. Slight cloudiness is normal.
• Do not shake the pre-filled syringe.

Storage of Vyvgart in pre-filled syringe

• Store in a refrigerator (2 °C - 8 °C).
• Do not freeze.
• You may also store the unopened pre-filled syringe at room temperature inside the original carton at temperatures up to 30 °C for a single period of up to 1 month after removal from the refrigerator. Dispose of it if not used within this 1-month period or before the expiry date, whichever comes first.
• Keep in the original packaging to protect 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

1.1 Remove the pre-filled syringe carton from the refrigerator.
1.2 Take out 1 pre-filled syringe from the carton and return the remaining pre-filled syringes to the refrigerator for later use.
1.3 Remove the pre-filled syringe from the tray.

2. Check the pre-filled syringe before

use
2.1 Check the expiry date on the pre-filled syringe.
Do not use the pre-filled syringe if the expiry date has been exceeded.
2.2 Check the condition of the pre-filled syringe and its cap.
Do not use the pre-filled syringe if it is cracked, broken, damaged, or if the cap is missing.
2.3 Check the appearance of the medicine in the pre-filled syringe. The medicine should appear transparent to pale yellow in color.
Slight opalescence is normal.
Do not use the pre-filled syringe if the colour of the medicine has changed 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 sit for
at least 30 minutes, so it reaches
room temperature.
Do not attempt to warm the pre-filled
syringe in any other way.
Do not use 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

4.1 Gather the following materials not provided
with the prefilled syringe.
4.2 Wash your hands with water and soap.

5. Remove the prefilled syringe cap

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

5.2 Bend the cap of the prefilled syringe
on one side to detach 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 not touch the tip of the prefilled syringe
after removing the cap.

5.3 Holding the prefilled syringe in one hand,
attach the needle by rotating it (clockwise/to the
right) until resistance is felt.
The needle is now attached to the prefilled syringe.

6. Choose and clean the injection site

on the abdomen
6.1 Choose an injection site on the abdomen
(abdominal area) at least 5 cm away
from the navel. Change the injection site each time.
Do not administer the injection into areas with
irritated, red, bruised, infected skin,
or areas with scars. Do not inject
into a vein. The pre-filled syringe is
for subcutaneous injection only.

6.2 Clean the selected injection site with a
cotton ball or pad soaked in alcohol and let it
air dry.
Do not blow on or touch the injection site
after cleaning.
Inject Vyvgart

7. Pull back the needle shield

and remove the cap
7.1 Pull back the needle shield.
Note: The needle shield will be used after injection to cover the needle and prevent accidental needlestick injuries.

7.2 Hold the pre-filled syringe body and remove the transparent needle cap with a straight motion.
Dispose of the needle cap in household waste.
Do not reattach the cap onto the needle.

8. Administer the injection

8.1 Pinch the clean injection site.
While pinching the skin, insert the
needle at an angle between 45 and
90 degrees.
Then release the pinched skin.
Do not pinch the skin too
tightly to avoid bruising.

8.2 To inject the medicine,
slowly push the plunger down until
it stops. It will take approximately
20–30 seconds to inject the full
dose of medicine.
You will feel some resistance as you
push down. If uncomfortable, inject
more slowly.
If needed, you may pause or change
your grip during the injection.
Do not attempt to force the
plunger down quickly, as this will
increase resistance.

8.3 After injecting all the liquid
medicine, remove the needle from
the skin straight out, without changing
the angle.
Dispose of the used syringe

9. Cover the needle and dispose of the used syringe

9.1 Carefully push the needle shield forward over the needle until it clicks securely into place, covering the needle.
This helps prevent accidental needle sticks.
Do not re-cap the needle;
use only the built-in needle shield to cover it.
9.2 Immediately after use, dispose of the used syringe, with the needle still attached, into a sharps disposal container.

Do not discard loose needles or syringes into household waste.
If you do not have a sharps disposal container, you may use a household container if it is:
made of strong plastic;
closable with a tight-fitting, puncture-resistant lid, without sharp items sticking out;
upright and stable;
leak-resistant;