VYVGART 20 mg/mL concentrate for infusion solution

2. What you need to know before you use Vyvgart

Do not use Vyvgart

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

Warnings and precautions

Talk to your doctor before you start using Vyvgart.

MGFA Class V

Your doctor cannot prescribe this medicine to you if you are connected to a ventilator due to muscle weakness from gMG (myasthenic crisis).

Infections

Treatment with Vyvgart may reduce your natural resistance to infections, so you should tell your doctor if you have any infection before you start using Vyvgart.

Infusion reactions and allergic reactions

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

You will be monitored for signs of an infusion reaction or allergic reaction during treatment and 1 hour after treatment.

Immunizations (vaccines)

Tell your doctor if you have been given any vaccine in the last 4 weeks or if you are planning to be vaccinated soon.

Children and adolescents

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

Elderly patients

No special precautions are needed for the treatment of patients over 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Vyvgart is not expected to affect your ability to drive or use machines.

Vyvgart contains sodium

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

This medicine will be prepared with a solution that contains sodium, and this should be taken into account regarding the patient's total daily sodium intake from all sources.

Vyvgart contains polysorbate

This medicine contains 4.1 mg of polysorbate 80 in each vial, equivalent to 0.2 mg/ml. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergy.

3. How to use Vyvgart

Your treatment will be given to you by your doctor or another healthcare professional. Your healthcare professional will first dilute the product. The dilution will be administered from a drip bag through a tube directly into one of your veins over 1 hour.

What dose of Vyvgart you will receive and how often

The dose you receive will depend on your body weight and will be given in cycles of one infusion per week for 4 weeks. Your doctor will decide when more treatment cycles are needed. Instructions for the healthcare professional on the proper use of this medicine are included at the end of this document.

If you receive more Vyvgart than you should

If you think you have been accidentally given a higher dose of Vyvgart than prescribed, contact your doctor for advice.

If you miss an appointment to receive Vyvgart

If you miss an appointment, contact your doctor immediately for advice and see the section "If you stop using Vyvgart".

If you stop using Vyvgart

Stopping or interrupting treatment with Vyvgart may cause your gMG symptoms to come back. Talk to your doctor before stopping treatment with Vyvgart. Your doctor will explain the possible side effects and risks. Your doctor will also want to monitor you closely.

If you have any other questions about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Your doctor will explain the possible side effects and the risks and benefits of Vyvgart before treatment.

Tell your doctor immediately if you notice:

Signs of a severe allergic reaction (anaphylactic reaction) such as swelling of the face, lips, throat, or tongue that makes it difficult to swallow or breathe, shortness of breath, feeling of loss of consciousness, or skin rash during or after the infusion.

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

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

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

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 Vyvgart administration
• nausea

Frequency not known(cannot be estimated from the available data)

• Allergic reactions during or after the infusion:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 on the label after "EXP". The expiry date refers to the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original package to protect from light.

Do not use this medicine if you notice particles and/or the liquid in the vial is discolored.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Vyvgart Composition

The active ingredient is efgartigimod alfa.

• Each 20 ml vial contains 400 mg of efgartigimod alfa (20 mg/ml).

The other components are:

• sodium dihydrogen phosphate monohydrate
• disodium hydrogen phosphate anhydrous
• sodium chloride
• arginine hydrochloride
• polysorbate 80
• water for injectable preparations

Product Appearance and Container Contents

Vyvgart is presented as a sterile concentrate for intravenous infusion (20 ml in a vial – pack size of 1 vial).

Vyvgart is a liquid. It is colorless to slightly yellow, transparent to almost transparent.

Marketing Authorization Holder and Manufacturer

argenx BV

Industriepark-Zwijnaarde 7

9052 Gent

Belgium

Manufacturer

Propharma Group The Netherlands

Schipholweg 73

2316 ZL Leiden

Netherlands

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Prospectus:

Other Sources of Information

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/. There are also links to other websites on rare diseases and orphan medicines.

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This information is intended solely for healthcare professionals:

Instructions for Use for Healthcare Professionals Handling Vyvgart

1. How is Vyvgart supplied?

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

1. Before Administration

Reconstitution and dilution must be performed in accordance with recommended practices, particularly with regard to asepsis.

Vyvgart must be prepared for administration by a qualified healthcare professional using an aseptic technique.

Using the formula in the table below, calculate the following:

• The dose of Vyvgart needed based on the patient's body weight at the recommended dose of 10 mg/kg. In patients weighing more than 120 kg, use a body weight 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 total volume of the 9 mg/ml (0.9%) sodium chloride injectable solution. The total volume of the diluted medicinal product is 125 ml.

Table 1. Formula

3. Preparation and Administration

• Do not administer Vyvgart as a slow intravenous injection or as an intravenous bolus injection.
• Vyvgart should only be administered by intravenous infusion, as described below.

Preparation

• Visually inspect the vial contents to ensure they are transparent to slightly opalescent, colorless to slightly yellow, and particle-free. If particles are observed and/or the vial liquid is discolored, the vial must be discarded. Do not shake the vials.
• Throughout the preparation of the diluted solution, use an aseptic technique:
• Carefully withdraw the required amount of Vyvgart from the appropriate number of vials using a sterile syringe and needle. Discard partially used or empty vials.
• Transfer the calculated dose of the product to an infusion bag.
• Dilute the product by adding the calculated amount of 9 mg/ml (0.9%) sodium chloride injectable solution to achieve a total volume of 125 ml.
• Gently invert the infusion bag containing the diluted product without shakingto ensure complete mixing of the product and diluent.
• The diluted efgartigimod alfa injectable solution in 9 mg/ml (0.9%) sodium chloride may be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene-vinyl acetate (EVA), and ethylene-propylene copolymer (polyolefin) infusion bags, as well as PE, PVC, and polyurethane/polypropylene infusion lines, and polyurethane (PUR) or PVC filters with a polyethersulfone (PES) or polyvinylidene fluoride (PVDF) filter membrane.

Administration

• Vyvgart must be administered by intravenous infusion only by a healthcare professional. Do not administer as a slow intravenous injection or as an intravenous bolus injection.
• Before administration, visually inspect the solution to ensure it does not contain particles.
• Infuse the total of 125 ml of diluted medicinal product over 1 hour using a 0.2 µm filter. Administer the entire solution. After administration of the product, the infusion line should be flushed with a 9 mg/ml (0.9%) sodium chloride injectable solution.
• It should be administered immediately after dilution, and the infusion of the diluted solution must be completed within 4 hours after dilution.
• Chemical and physical stability has been demonstrated for 24 hours at 2°C to 8°C. From a microbiological point of view, unless the dilution method precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user. Do not freeze. Allow the diluted medicinal product to reach room temperature before administration. Complete the infusion within 4 hours after removal from the refrigerator. The diluted medicinal product must not be heated in any way other than at room temperature.
• In the event of infusion reactions, the infusion should be administered at a slower rate, interrupted, or discontinued.
• No other medicinal products should be injected into the infusion line ports or mixed with Vyvgart.

1. Special Handling and Storage Conditions

Store the vials in a refrigerator (between 2°C and 8°C) until use. Do not freeze. Keep in the original packaging to protect from light.

Do not use this medicinal product after the expiry date stated on the carton after "EXP". The expiry date is the last day of the month indicated.