efgartigimod alfa: package leaflet

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

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

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

Do not use Vyvgart
- if you are allergic to efgartigimod alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Vyvgart.

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

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

Infusion reactions and allergic reactions
Vyvgart contains a protein that can cause reactions such as rash or itching in some people. Vyvgart may cause anaphylactic reaction (a serious allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat or tongue which makes it difficult to swallow or breathe, or shortness of breath, feeling of losing consciousness, or skin rash during or after the infusion, then tell your doctor immediately.
You will be monitored for signs of an infusion reaction or allergic reaction during and for 1 hour after treatment.

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

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

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

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

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Vyvgart contains sodium
This medicine contains 33.2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult. This medicinal product will be further prepared for administration with sodium-containing solution and this should be considered in relation to the total sodium intake to the patient from all sources per day.

Vyvgart contains polysorbate
This medicine contains 8.2 mg of polysorbate 80 in each vial which is equivalent to 0.4 mg/mL.
Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

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

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

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

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

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

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

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

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

Very common (may affect more than 1 in 10 people)
- nose and throat (upper respiratory tract) infections.

Common (may affect up to 1 in 10 people)
- pain or a burning sensation during urination, which may be a sign of a urinary tract infection
- inflammation of the airways in the lungs (bronchitis)
- muscle pain (myalgia)
- headache during or after the administration of Vyvgart
- 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 which makes it difficult to swallow or breathe, shortness of breath
- pale skin, a weak and rapid pulse, or a feeling of loss of consciousness
- sudden rash, itching, or hives.

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C - 8 °C).

Do not freeze.

Store in the original package in order to protect from light.

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

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

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

What Vyvgart contains
The active substance is efgartigimod alfa.
- Each 20 mL vial contains 400 mg efgartigimod alfa (20 mg/mL).
The other ingredients are:
- L-histidine
- L-histidine hydrochloride monohydrate
- L-methionine
- sodium chloride
- sucrose
- L-arginine hydrochloride
- polysorbate 80 (E433)
- water for injections

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

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

For any information about this medicine, please 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 medinfobe@argenx.com
Lietuva argenx BV
Tel: +370 (0)800 80 052 medinfolt@argenx.com
България argenx BV
Teл.: +359 (0)800 46 273 medinfobg@argenx.com
Luxembourg/Luxemburg argenx BV
Tél/Tel: +352 800 25 233 medinfolu@argenx.com
Česká republika argenx BV
Tel: +420 800 040 854 medinfocz@argenx.com
Magyarország argenx BV
Tel.: +36 800 88 578 medinfohu@argenx.com
Danmark argenx BV
Tlf.: +45 80 25 41 88 medinfodk@argenx.com
Malta argenx BV
Tel: +356 800 65 101 medinfomt@argenx.com
Deutschland argenx Germany GmbH
Tel: +49 (0)800 180 3963 medinfode@argenx.com
Nederland argenx BV
Tel: +31 (0)800 023 2882 medinfonl@argenx.com
Eesti argenx BV
Tel: +372 800 010 0919 medinfoee@argenx.com
Norge argenx BV
Tlf: +47 800 62 225 medinfono@argenx.com
Ελλάδα
Medison Pharma Greece Single Member Societe
Anonyme
Τηλ: +30 210 0100 188 medinfogr@argenx.com
Österreich argenx BV
Tel: +43 (0)800 017936 medinfoat@argenx.com
España argenx Spain S.L.
Tel: +34 900 876 188 medinfoes@argenx.com
Polska argenx BV
Tel.: +48 800 005 155 medinfopl@argenx.com
France argenx France SAS
Tél: +33 (0)1 88 89 89 92 medinfofr@argenx.com
Portugal argenx Spain S.L. Sucursal Em Portugal
Tel: +351 800 180 844 medinfopt@argenx.com
Hrvatska argenx BV
Tel: +385 (0)800 806 524 medinfohr@argenx.com
România argenx BV
Tel: +40 (0)800 360 912 medinforo@argenx.com

Ireland argenx BV
Tel: +353 1800 851 868 medinfoie@argenx.com
Slovenija argenx BV
Tel: +386 (0)80 688 955 medinfosi@argenx.com
Ísland argenx BV
Sími: +354 800 4422 medinfois@argenx.com
Slovenská republika argenx BV
Tel: +421 (0)800 002 646 medinfosk@argenx.com
Italia argenx Italia s.r.l
Tel: +39 800 729 052 medinfoit@argenx.com
Suomi/Finland argenx BV
Puh/Tel: +358 (0)800 412 838 medinfofi@argenx.com
Κύπρος argenx BV
Τηλ: +357 800 77 122 medinfocy@argenx.com
Sverige argenx BV
Tel: +46 (0)20 12 74 56 medinfose@argenx.com
Latvija argenx BV
Tel: +371 80 205 267 medinfolv@argenx.com

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Instructions for use for healthcare professionals handling Vyvgart

1.
How is Vyvgart supplied?

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

2.
Before administration

Reconstitution and dilution should be performed in accordance with good practices rules, particularly for the respect of asepsis.

Vyvgart should 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 bodyweight at the recommended dose of 10 mg/kg. For patients weighing over 120 kg use a bodyweight of 120 kg to calculate the dose.
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%) solution for injection. The total volume of diluted medicinal product is 125 mL.

Table 1. Formula
Step 1 – Calculate the dose (mg)
10 mg/kg x weight (kg)
Step 2 – Calculate the volume of concentrate (mL) dose (mg) ÷ 20 mg/mL
Step 3 – Calculate the number vials volume of concentrate (mL) ÷ 20 mL
Step 4 – Calculate the volume of sodium chloride 9 mg/mL
(0.9%) solution for injection (mL)
125 mL – concentrate volume (mL)

3.
Preparation and Administration

• Do not administer Vyvgart as an intravenous push or bolus injection.
• Vyvgart should only be administered via intravenous infusion as described below.

Preparation
- Visually inspect that the vial content is clear to slightly opalescent, colourless to slightly yellow, and devoid of particulate matter. If visible particles are observed and/or the liquid in the vial is discoloured, the vial must be discarded. Do not shake the vials.
- Using aseptic technique throughout the preparation of the diluted solution:
- Gently withdraw the required amount of Vyvgart from the appropriate number of vials with a sterile syringe and needle. Discard any 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%) solution for injection to make a total volume of 125 mL.
- Gently invert the infusion bag containing the diluted product without shaking to ensure thorough mixing of the product and the diluent.

• The efgartigimod alfa solution diluted in sodium chloride 9 mg/mL (0.9%) solution for injection can be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene vinyl acetate (EVA) and ethylene/polypropylene copolymer bags (polyolefins bags), as well as with PE, PVC and polyurethane/polypropylene infusion lines, together with polyurethane (PUR) or PVC filters with polyethersulfone (PES) or polyvinylidene fluoride (PVDF) filter membrane.

Administration
- Vyvgart should be administered via intravenous infusion by a healthcare professional. Do not administer as a push or bolus injection.
- Inspect the solution visually for particulate matter prior to administration.
- Infuse the total 125 mL of diluted medicine over 1 hour using a 0.2 µm filter. Administer the full amount of solution. After administration of the product, the line should be flushed with sodium chloride 9 mg/mL (0.9%) solution for injection.
- Administer immediately after dilution and complete the infusion of diluted solution within 4 hours of dilution.
- Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, unless the method of dilution precludes the risks of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions 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 should not be heated in any other manner than via ambient air.
- Should infusion reactions occur, the infusion should be administered at a slower rate, interrupted or discontinued.
- Other medicines should not be injected into infusion side ports or mixed with Vyvgart.

4.
Special Handling and Storage

Store the vials in a refrigerator (2 °C - 8 °C) until the time of use. Do not freeze. Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.

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

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

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

Vyvgart is also used to treat adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a form of autoimmune disease. CIDP causes muscle weakness and/or numbness mainly in the legs and arms. Vyvgart can protect the nerves from being attacked and reduce the symptoms of the disease and their impact on daily activities.

Do not use Vyvgart
- if you are allergic to efgartigimod alfa or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Vyvgart.

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

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

Injection reactions and allergic reactions
Vyvgart contains a protein that can cause reactions such as rash or itching in some people. Vyvgart may cause anaphylactic reaction (a serious allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat or tongue which makes it difficult to swallow or breathe, shortness of breath, feeling of loss of consciousness, or skin rash during or after the injection, then tell your doctor immediately.

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

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

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

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

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

Vyvgart contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodium-free”.

Vyvgart contains polysorbate
This medicine contains 2.7 mg of polysorbate 80 in each vial which is equivalent to 0.4 mg/mL.
Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

What dose of Vyvgart you will receive and how often

Generalized myasthenia gravis

The recommended dose is 1 000 mg given in cycles of one injection per week for 4 weeks. Your doctor will determine when further treatment cycles are needed.

If you are already on intravenous Vyvgart treatment and wish to transition to Vyvgart subcutaneous, you should receive the subcutaneous injection instead of your intravenous infusion at the start of the next treatment cycle.

Chronic inflammatory demyelinating polyneuropathy

The recommended dose is 1 000 mg, one injection per week. Depending on how you respond to treatment, your doctor may change this to 1 injection every 2 weeks.

Injecting Vyvgart
Vyvgart is given by injection under the skin (subcutaneously). You and your doctor should decide if, after adequate training, you or your caregiver may inject Vyvgart. The first self-injection should be carried out in front of your healthcare provider. It is important not to try to inject Vyvgart before being trained by a healthcare professional.

If you or your caregiver inject Vyvgart, you or your caregiver must carefully read and follow the Instructions for administration at the end of this leaflet (see “Important instructions for use”). Talk to your doctor, pharmacist or nurse if you have any questions about giving yourself an injection.

If you use more Vyvgart than you should
Because Vyvgart is given in one single-use vial, it is unlikely that you will receive too much.
However, if you are worried, please contact your doctor, pharmacist or nurse for advice.

If you miss a dose of or forget an appointment to receive Vyvgart
Keep track of your next dose. It is important to use Vyvgart exactly as prescribed by your doctor.
- If you miss your dose within three days of when you are supposed to take it, take your dose as soon as you remember and then follow your original dosing schedule.
- If you miss your dose by more than three days, ask your doctor when to take your next dose.
- If you forget an appointment, please contact your doctor immediately for advice.

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

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

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

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

Tell your doctor straight away if you notice:
Signs of a serious allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat or tongue which makes it difficult to swallow or breathe, shortness of breath, feeling of loss of consciousness, or skin rash during or after the injection.

If you are not sure what the side effects below are, ask your doctor to explain them to you.

Very common (may affect more than 1 in 10 people)
- nose and throat (upper respiratory tract) infections
- reactions where the injection was given, which may include redness, itching, pain. These injection site reactions are usually mild to moderate and usually occur within a day after the injection.

Common (may affect up to 1 in 10 people)
- pain or a burning sensation during urination, which may be a sign of a urinary tract infection
- inflammation of the airways in the lungs (bronchitis)
- muscle pain (myalgia)
- nausea.

Not known (frequency cannot be estimated from the available data)
- allergic reactions during or after injection
- swelling of the face, lips, throat, or tongue which makes it difficult to swallow or breathe, shortness of breath
- pale skin, a weak and rapid pulse, or a feeling of loss of consciousness
- sudden rash, itching, or hives.

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

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and on the label after “EXP”. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C - 8 °C). Do not freeze.
If needed, unopened vials may be stored at room temperature (up to 30 °C) for up to 3 days. After storage at room temperature unopened vials may be returned to the refrigerator. The total amount of time outside cold storage and at room temperature should not exceed 3 days.

Store in the original package in order to protect from light.

Do not use this medicine if you notice visible particles.

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

What Vyvgart contains
- The active substance is efgartigimod alfa. Each vial contains 1 000 mg efgartigimod alfa in 5.6 mL. Each mL contains 180 mg of efgartigimod alfa.
- The other ingredients are: Recombinant human hyaluronidase (rHuPH20), L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, Polysorbate 80 (E433), Sodium chloride, sucrose, Water for injections. See section 2 “Vyvgart contains sodium”.

What Vyvgart looks like and contents of the pack
Vyvgart is a ready to use, slightly yellow, 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 any information about this medicine, please 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 medinfobe@argenx.com
Lietuva argenx BV
Tel: +370 (0)800 80 052 medinfolt@argenx.com
България argenx BV
Teл.: +359 (0)800 46 273 medinfobg@argenx.com
Luxembourg/Luxemburg argenx BV
Tél/Tel: +352 800 25 233 medinfolu@argenx.com
Česká republika argenx BV
Tel: +420 800 040 854 medinfocz@argenx.com
Magyarország argenx BV
Tel.: +36 800 88 578 medinfohu@argenx.com
Danmark argenx BV
Tlf.: +45 80 25 41 88 medinfodk@argenx.com
Malta argenx BV
Tel: +356 800 65 101 medinfomt@argenx.com
Deutschland argenx Germany GmbH
Tel: +49 (0)800 180 3963 medinfode@argenx.com
Nederland argenx BV
Tel: +31 (0)800 023 2882 medinfonl@argenx.com
Eesti argenx BV
Tel: +372 800 010 0919 medinfoee@argenx.com
Norge argenx BV
Tlf: +47 800 62 225 medinfono@argenx.com

Ελλάδα
Medison Pharma Greece Single Member Societe
Anonyme
Τηλ: +30 210 0100 188 medinfogr@argenx.com
Österreich argenx BV
Tel: +43 (0)800 017936 medinfoat@argenx.com
España argenx Spain S.L.
Tel: +34 900 876 188 medinfoes@argenx.com
Polska argenx BV
Tel.: +48 800 005 155 medinfopl@argenx.com
France argenx France SAS
Tél: +33 (0)1 88 89 89 92 medinfofr@argenx.com
Portugal argenx Spain S.L. Sucursal Em Portugal
Tel: +351 800 180 844 medinfopt@argenx.com
Hrvatska argenx BV
Tel: +385 (0)800 806 524 medinfohr@argenx.com
România argenx BV
Tel: +40 (0)800 360 912 medinforo@argenx.com
Ireland argenx BV
Tel: +353 1800 851 868 medinfoie@argenx.com
Slovenija argenx BV
Tel: +386 (0)80 688 955 medinfosi@argenx.com
Ísland argenx BV
Sími: +354 800 4422 medinfois@argenx.com
Slovenská republika argenx BV
Tel: +421 (0)800 002 646 medinfosk@argenx.com
Italia argenx Italia s.r.l
Tel: +39 800 729 052 medinfoit@argenx.com
Suomi/Finland argenx BV
Puh/Tel: +358 (0)800 412 838 medinfofi@argenx.com
Κύπρος argenx BV
Τηλ: +357 800 77 122 medinfocy@argenx.com
Sverige argenx BV
Tel: +46 (0)20 12 74 56 medinfose@argenx.com
Latvija argenx BV
Tel: +371 80 205 267 medinfolv@argenx.com

This leaflet was last revised in.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:
https://www.ema.europa.eu. There are also links to other websites about rare diseases and treatments.

------------------------------------------------------------------------------------------------------------------------ Important instructions for use Vyvgart 1 000 mg solution for injection efgartigimod alfa Subcutaneous use

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Be sure to read and understand these instructions for use before injecting Vyvgart.
If you or your caregiver are willing to administer Vyvgart, you will get training on how to inject Vyvgart by your healthcare professional. Your healthcare professional should show you or your caregiver how to prepare and inject Vyvgart properly before using it for the first time. A demonstration of proper self-administration under supervision of healthcare professional is considered necessary. It is important that you do not try to inject the medicinal product until you have been trained and you or your caregiver are sure that you understand how to use Vyvgart. Ask your healthcare professional if you have any questions.

Important information you need to know before injecting Vyvgart subcutaneous
- For subcutaneous use only.
- The vial is for single use only. Do not save vials, even if they are not empty.
- Do not use a vial if you see unusual cloudiness or visible particles. The medicine should appear slightly yellow, clear to slightly cloudy.
- Do not shake the vial during handling.
- Do not use damaged vials or vials missing a protective cap. Report and return damaged or uncapped vials to the pharmacy.

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

Package contents
1 vial containing Vyvgart

Vyvgart package leaflet and instructions for use

Additional supplies not included
Store additional supplies at room temperature in a dry location
Alcohol swabs

Syringe 10 mL

Transfer needle 18-gauge, ≥ 38 mm length
Winged infusion set 25-gauge, 30 cm tubing, maximum priming volume of 0.4 mL

Sterile gauze

Adhesive bandage
Sharps container

Preparing the supplies
Step 1
Remove vial carton from the refrigerator.

Step 2
Remove the vial from the carton and check:
• the vial is not cracked, broken, missing the protective cap, or shows any signs of damage.
• the expiry date has not passed.

If any of the conditions above are not met, do not inject, and report this information to the pharmacy.

Step 3
Wait at least 15 minutes for the vial to naturally warm-up to room temperature.

Check if the medicine in the vial is slightly yellow, clear to slightly cloudy, and has no visible particles.

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

Step 4
Collect all of the following additional supplies:
• 2 alcohol swabs
• 1 syringe 10 mL
• 1 transfer needle 18-gauge
• 1 winged infusion set 25-gauge x 30 cm
• 1 sterile gauze
• 1 adhesive bandage
• 1 sharps container (see Step 28)

Step 5
5a. Clean the work area.
5b. Wash your hands with soap and thoroughly dry them.

Preparing the syringe
Step 6
Remove the plastic flip-off protective cap from the vial.

The aluminium shield should remain in place.

Step 7
Clean the rubber stopper with a new alcohol swab.

Allow to air dry naturally for at least 30 seconds. Do not blow on the rubber stopper.

Step 8
Unwrap the syringe and transfer needle. Push the transfer needle onto the syringe and twist it clockwise until the needle is firmly connected to the syringe.

Do not touch the tip of the syringe or the bottom of the needle to avoid germs and infection risk.

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

Step 10
10a. Hold the syringe at the needle hub where the syringe is connected to the needle.
10b. Grip the transfer needle cap and carefully pull the needle cap straight off, away from your body.
10c. Place the transfer needle cap down on a clean, flat surface.

• Do not throw the cap away. You will need to recap and remove the transfer needle after use.
Keep the needle sterile:
• Do not touch the needle or needle tip.
• Do not place it on a surface after the needle cap has been removed.

Step 11
Keep the vial upright on a flat surface and insert the transfer needle through the centre of the disinfected rubber stopper.

Do not puncture the vial’s rubber stopper more than one time to avoid leaking.

Step 12
Turn the vial upside down while keeping transfer needle in the vial.
10b)
10c)

Step 13
13a. Make sure the transfer needle in the vial points upwards with the needle tip above the medicine solution.
13b. Gently push the plunger to inject all the air from the syringe into the empty space above the medicine solution in the vial.
13c. Keep your finger pressed down on the syringe plunger.

Do not inject air into the medicine solution as this could create air bubbles or foam.

Step 14
Fill the syringe, as follows:
14a. Keep your finger pressed on the syringe plunger and slide the transfer needle tip into the medicine solution in the neck of the vial (close to the vial cap) so that the needle tip remains completely covered in the solution.
14b. Slowly pull back the plunger, keeping the transfer needle tip in the solution to avoid air bubbles and foam in the syringe.

Fill the syringe with the entire content of the vial.

Step 15
Remove large air bubbles, if present.
15a. Keep the transfer needle in the vial and check the syringe for large air bubbles.
15b. Remove the large air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe.
15c. Move the transfer needle tip above the medicine solution and slowly push the plunger up to push the air bubbles out of the syringe.
15d. To remove any remaining medicine solution from the vial, move the tip of the transfer needle into the solution again and slowly pull back the plunger until you have the full contents of the vial in the syringe.
15e. Repeat the steps above until you have removed the large air bubbles.
If you cannot remove all of the liquid from the vial, turn the vial upright to reach the remaining amount.

14a)
14b)
15c)
15e)

Step 16
16a. Turn 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 scoop upwards to cover the needle.
16c. After the transfer needle is covered, twist the transfer needle cap onto the syringe to fully attach it.

Step 17
17a. Gently pull and twist the transfer needle counter- clockwise to remove it from the syringe.
17b. Throw away (dispose of) the transfer needle in the sharps container.

17a)
17b)
16a)
16b)
16c)

Preparing to inject Vyvgart
Step 18
18a. Remove the cap from the end of the winged infusion set.

18b. Gently push and twist the end of the winged infusion set clockwise onto the syringe until firmly connected.

The final syringe setup should look like the figure to 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 pressing the syringe plunger until the plunger is at the 5.6 mL mark. You should see some liquid at the end of the needle.
19b. Place the syringe and attached winged infusion set down on the clean, flat surface.

Do not wipe off any excess medicine solution expelled from the infusion set while filling the tubing.

Step 20
Choose an injection site
• on the abdomen (belly area) that is at least 5 cm away from the belly button

Choose a different injection site each time you inject (rotate the site) to decrease discomfort.

Note:
Do not inject into areas where the skin is red, bruised, tender, hard, or into areas where there are moles or scars.

Step 21
Disinfect the injection site with a new alcohol swab. Use a circular motion and wipe from inside to outside.

Allow the site to air dry for at least 30 seconds.

Do not touch the injection site after disinfecting.

Injecting Vyvgart
Step 22
22a. Remove the needle cap carefully from the winged infusion set.
22b. Fold the wings of the infusion set upwards and hold the wings between your thumb and index finger, with the needle below the wings.

Note:
To avoid infection, make sure the needle does not come into contact with anything prior to skin insertion.

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

Do not hold the skin too tight to avoid bruising.

Step 24
Insert the needle into the middle of the pinched skin area at an angle of about 45 degrees.

Note:
The needle should smoothly insert into the skin. If you feel resistance, you can pull the needle back slightly.

Step 25
Check the infusion set. Make sure there is no blood.

Important:
If you see blood, slightly pull back on the needle without removing the needle from the skin.

22a)
22b)

Step 26
Inject by pushing the plunger of the syringe with steady pressure until no medicine remains in the syringe. This corresponds to the injection of the recommended dose of 5.6 mL. The injection usually takes 30 to 90 seconds.

Note:
• If you experience discomfort, or if any of the medicine flows back into the infusion tubing, you can inject more slowly.
• There will be some fluid left in the infusion tubing that is not injected. This is normal and the remaining medicine can be thrown away.

Step 27
27a. After all solution is injected, remove the needle from the skin.
27b. Cover the injection site with a sterile dressing, like an adhesive bandage.

Note:
If there is a small drop of blood after removing the needle, do not worry. This can happen if the needle nicks the skin during removal. Dab the blood with a sterile piece of gauze and apply gentle pressure. Further bleeding should not occur. Apply a sterile dressing to cover the site.

Disposing of Vyvgart
Step 28
Throw away (dispose of) the winged infusion set (with the attached needle and syringe) and the vial into the sharps container.

If you do not have an sharps disposal container, a household container can be used if it is:
• Made of heavy-duty plastic;
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps spilling out;
• Upright and stable;
• Leak-resistant;
• Appropriately labeled with a warning that hazardous waste is inside the container.

Dispose of the full container as instructed by your healthcare provider or pharmacist.

Note:
Always keep the sharps container out of the sight and reach of children.

2 Checking the pre-filled syringe before use

syringe.

2.2 Check the condition of the pre-filled syringe and the pre-filled syringe cap.

Do not use the pre-filled syringe if the expiry date has passed.
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 look clear to light yellow in colour. A little cloudiness is normal.

Preparing for the injection

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

4.1 Gather the following supplies that are not provided with the pre-filled syringe.

4.2 Wash hands with soap and water.

attach the needle
5.1 Carefully open the needle package, remove the needle. Throw away the packaging via the household waste.

Do not use the pre-filled syringe if the medicine is discoloured or contains particles.
Do not attempt to warm the pre-filled syringe in any other way.
Do not use the pre-filled syringe if it has been at room temperature for longer than 1 month.

5.2 Bend the pre-filled syringe cap to one side to snap it off and remove it from the pre-filled syringe.
Throw away the syringe cap in the household waste, and set the pre-filled syringe on a clean and flat surface.

5.3 Hold the pre-filled syringe in one hand and attach the needle to the pre-filled syringe by twisting it on (clockwise/to the right) until you feel resistance.

The needle is now attached to the pre-filled syringe.

abdomen
6.1 Choose an injection site on the abdomen
(belly area) at least 5 cm away from the belly button (navel). Change the injection site for each injection.
6.2 Clean the chosen injection site with an alcohol swab and let it air dry.

Do not inject into skin that is irritated, red, bruised, infected or scarred. Do not inject into a vein. The pre-filled syringe is for injection (under the skin) only.
Do not touch the tip of the pre-filled syringe after the cap has been removed.
Do not blow on or touch the injection site after it has been cleaned.

Injecting Vyvgart

7. Pulling back the needle shield and removing the needle cap
7.1 Pull the needle shield back.

Note: The needle shield will be used after the injection to cover the needle and protect from needle-stick injuries.

7.2 Hold the pre-filled syringe body and remove the clear needle cap by pulling it straight off of the needle.
Throw away the needle cap into the household waste.

8. Giving the injection
8.1 Pinch the cleaned injection site.
While pinching the skin, insert the needle at a 45 to 90 degree angle into the pinched skin.
Then release the pinched skin.

Do not put the needle cap back on the needle.
Do not pinch the skin too tightly as this can cause bruising.

8.2 Slowly press the plunger down all the way until it stops in order to inject the medicine. It will take approximately 20-30 seconds to inject all of the medicine.
You will feel resistance as you press down. In case of discomfort inject more slowly.

It is ok if you need to pause or change your grip during the injection.

8.3 After all the liquid medicine is injected, remove the needle from the skin by pulling it straight out without changing the angle.

Disposing of the used syringe

9 Covering the needle and throwing away the used syringe
9.1 Carefully push the needle shield over the needle until it snaps into place and covers the needle.
This helps to prevent needle-stick injuries.

9.2 Throw away the used syringe, with the needle still attached, into the sharps container immediately after use.
If you do not have a sharps container, a household container can be used if it:
• Is made of heavy-duty plastic;
• Can be closed with a tight-fitting, puncture-resistant lid, without sharps spilling out;
• Is upright and stable;

Do not put the needle cap back on;
only use the needle shield to cover the needle.
Do not throw away (dispose of) loose needles and syringes in your household waste.
Do not try to force the plunger down quickly as this will make the plunger harder to press.

• Is leak-resistant;
• Is appropriately labelled with a warning that hazardous waste is inside the container.

Dispose of the full container as instructed by your doctor, nurse or pharmacist.

10 Treating the injection site
If there is a small amount of blood or liquid at the injection site, press a gauze on it until the bleedings stops.
If needed, you may apply a small adhesive bandage.