Vyvgart 20 mg/ml concentrado para soluciÓn para perfusiÓn

Prospect: information for the patient

Vyvgart 20 mg/ml concentrate for infusion solution

efgartigimod alfa

This medicine is subject to additional monitoring, which will expedite the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

1.What is Vyvgart and for what it is used

2.What you need to know before starting to use Vyvgart

3.How to use Vyvgart

4.Possible adverse effects

5.Storage of Vyvgart

6.Contents of the package and additional information

What is Vyvgart

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

What is Vyvgart used for

Vyvgart is used in combination with standard treatment to treat adults with generalized myasthenia gravis (MG), an autoimmune disease that causes muscle weakness. MG can affect various muscle groups throughout the body. The disease can also cause shortness of breath, extreme fatigue, and difficulty swallowing.

In patients with MG, autoantibodies against IgG attack and damage proteins on nerves called acetylcholine receptors. Due to this damage, nerves are unable to normally contract muscles, causing muscle weakness and difficulty moving. By binding to the FcRn protein and reducing autoantibody levels, Vyvgart may improve muscle contraction ability and reduce disease symptoms and their impact on daily activities.

No use Vyvgart

• if you are allergic to efgartigimod alfa or any of the other components of this medication (listed in section6).

Warnings and Precautions

Consult your doctor before starting to use Vyvgart.

MGFA Class V

Your doctor cannot prescribe this medication if you are connected to a ventilator due to muscle weakness caused by MG (myasthenic crisis).

Infections

The treatment with Vyvgart may reduce your natural resistance to infections, so inform your doctor if you have any infections before starting to use Vyvgart.

Infusion Reactions and Allergic Reactions

Vyvgart contains a protein that may cause reactions such as rash or itching in some people. Vyvgart may cause anaphylactic reaction (severe allergic reaction). If you experience allergic reactions such as facial swelling, 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, inform your doctor immediately.

You will be monitored to detect signs of infusion reaction or allergic reaction during treatment and 1hour after the same.

Vaccinations (Vaccines)

Inform your doctor if you have been administered any vaccine in the last 4weeks, or if you plan to get vaccinated in the near future.

Children and Adolescents

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

Older Adults

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

Other Medications and Vyvgart

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and Operating Machines

No expected impact of Vyvgart on the ability to drive or operate machines.

Vyvgart contains Sodium

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

This medication will be prepared additionally for administration with a solution that contains sodium, and this should be taken into account regarding the total daily sodium intake of the patient from allsources.

Your doctor or other healthcare professional will administer the treatment. Your healthcare professional will first dilute the product. The diluted product will be administered through an infusion bag via 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 administered in cycles of one infusion per week for 4 weeks. Your doctor will decide when additional treatment cycles are needed. Instructions for healthcare professionals on the proper use of this medication are included at the end of this document.

If you receive more Vyvgart than you should

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

If you missed a scheduled appointment to receive Vyvgart

If you missed an appointment, contact your doctor immediately for advice and refer to the section "If you interrupt treatment with Vyvgart".

If you interrupt treatment with Vyvgart

Interrupting or stopping treatment with Vyvgart may cause your symptoms of MGG to return. Consult with your doctor before stopping treatment with Vyvgart. Your doctor will explain the possible side effects and risks. Your doctor will also want to closely monitor you.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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 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 unsure about the adverse effects listed below, ask your doctor to explain them to you.

Very Common(may affect more than 1 in 10 patients)

• Upper respiratory tract infections (nasopharyngitis)

Common(may affect up to 1 in 10 patients)

• Pain or burning sensation while 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

Unknown Frequency

• 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the label after "CAD". The expiration date is the last day of the month indicated.

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

Do not freeze.

Store in the original packaging to protect it from light.

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

The product must be administered immediately after dilution and the infusion (drip) must be completed within 4 hours after dilution. Allow the diluted medication to reach room temperature before administering it. The infusion must be completed within 4 hours after removal from the refrigerator.

Medications should not be disposed of through drains or trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Vyvgart

The active ingredient is efgartigimod alfa.

• Each vial of 20 ml 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 injection

Appearance of the product and contents of the package

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

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

Holder of the marketing authorization and responsible for manufacturing

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 medication by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medication 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 drugs.

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This information is intended solely for healthcare professionals:

Instructions for use for healthcare professionals handling Vyvgart

1.How is Vyvgart administered?

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

2.Before administration

The reconstitution and dilution must be carried out in accordance with recommended practices, particularly in terms of 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:

Table1. Formula

3.Preparation and administration

Preparation

• Visually check that the contents of the vial are transparent to slightly opalescent, colorless to slightly yellow, and free of particles. If particles are observed or the liquid in the vial is discolored, the vial must be discarded. Do not shake the vials.
• During the preparation of the diluted solution, use an aseptic technique:
• Carefully extract the required amount of Vyvgart from the appropriate number of vials using a sterile syringe and needle. Discard any partially used or empty vials.
• Transfer the calculated dose of the product to an infusion bag.
• Dilute the extracted product by adding the calculated amount of sodium chloride 9 mg/ml (0.9%) injection solution to obtain a total volume of 125 ml.
• Gently invert the infusion bag containing the diluted productwithout shaking it, to ensure complete mixing of the product and the diluent.
• The efgartigimod alfa diluted in sodium chloride 9 mg/ml (0.9%) injection solution may be administered using polyethylene (PE), polyvinyl chloride (PVC), ethylene-vinyl acetate (EVA), and polyethylene/polypropylene (PE bags), as well as with PE, PVC, and polyurethane/polypropylene infusion sets, and polyurethane (PUR) or PVC filters with a PES or PVDF membrane filter.

Administration

4.Special handling and storage conditions

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

Do not use this medication after the expiration date appearing on the box after "CAD". The expiration date is the last day of the month indicated.