Vyvgart 20 mg/ml concentrate for solution for infusion

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vyvgart 20 mg/ml concentrate for solution for infusion

efgartigimod alfa

This medicine is subject to additional monitoring, which will allow for quicker detection of new safety information. You can help by reporting any adverse reactions you may experience. Information on how to report adverse reactions is provided at the end of section 4.

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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 adverse reactions
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 parts of a person's body.

What Vyvgart is used for

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

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

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

MGFA Class V

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

Infections

Treatment with Vyvgart may reduce your body’s natural resistance to infections. Therefore, inform your doctor if you have any infection 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 an anaphylactic reaction (serious allergic reaction). If you experience allergic reactions such as swelling of the face, lips, throat, or tongue that makes swallowing or breathing difficult, 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 treatment and for 1 hour after treatment.

Immunizations (vaccines)

Inform your doctor if you have received any vaccine within the last 4 weeks, or if you plan to receive a vaccine in the near future.

Children and adolescents

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

Elderly patients

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 need to take any other medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist 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 33.2 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 1.7% of the maximum daily sodium intake recommended for an adult.

This medicine will additionally be prepared for administration with a solution containing 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 8.2 mg of polysorbate 80 per vial, equivalent to 0.4 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergies.

3. How to use Vyvgart

Vyvgart will be administered to you by your doctor or another healthcare professional. Your healthcare provider will first dilute the product. The diluted solution will then be given via an intravenous infusion 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 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 medicine are included at the end of this document.

If you receive more Vyvgart than you should

If you suspect that you have accidentally been given more Vyvgart than prescribed, contact your doctor immediately for advice.

If you miss an appointment to receive Vyvgart

If you miss 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 MG symptoms to return. Consult your doctor before interrupting treatment with Vyvgart. Your doctor will explain the potential adverse effects and risks. Your doctor will also want to monitor you closely.

If you have any further 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 everyone gets them.

Your doctor will explain the possible side effects and the risks and benefits of Vyvgart to you 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 causing difficulty swallowing or breathing, shortness of breath, feeling faint or a skin rash during or after the infusion.

If you are unsure about the side effects listed below, 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 infections)

Common (may affect up to 1 in 10 people)

• Pain or burning sensation when passing urine, 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

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

• Allergic reactions during or after infusion:

• Swelling of the face, lips, throat or tongue causing difficulty swallowing or breathing, shortness of breath.

• Pale skin, weak and rapid pulse, or feeling faint.

• Sudden rash, itching, or hives.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the national reporting system included 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 stated on the carton and label following “EXP”. The expiry date refers to the last day of the month indicated.

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

Do not freeze.

Keep in the original packaging to protect from light.

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

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Vyvgart

The active substance is efgartigimod alfa.

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

The other components are:

• L-histidine
• L-histidine monohydrochloride monohydrate
• L-methionine
• sodium chloride
• sucrose
• L-arginine hydrochloride
• polysorbate 80 (E433)
• water for injections

Nature of the product and pack 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 colourless to slightly yellow, clear to almost clear.

Marketing Authorization Holder and Manufacturer

argenx BV

Industriepark-Zwijnaarde 7

9052 Gent

Belgium

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of last revision of this leaflet:

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu/. Links to other websites on rare diseases and orphan medicinal products are also available.

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

2. Prior to 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 required dose of Vyvgart based on the patient's body weight at the recommended dose of 10 mg/kg. For 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 required.
• The total volume of sodium chloride 9 mg/ml (0.9%) 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 slow intravenous injection or as intravenous bolus injection.
• Vyvgart should only be administered by intravenous infusion, as described below.

Preparation

• Visually inspect the vial contents to ensure they are clear to slightly opalescent, colorless to slightly yellow, and free of particles. If particles are observed and/or the liquid in the vial is discolored, discard the vial. Do not shake the vials.

• Use aseptic technique throughout the preparation of the diluted solution:

• 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 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 achieve a total volume of 125 ml.

• Gently invert the infusion bag containing the diluted product without shaking to ensure complete mixing of the product and diluent.

• The efgartigimod alfa injectable solution diluted in sodium chloride 9 mg/ml (0.9%) 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/propylene infusion lines, along with polyurethane (PUR) or PVC filters with a filter membrane of polyethersulfone (PES) or polyvinylidene fluoride (PVDF).

Administration

• Vyvgart must be administered by intravenous infusion only by a healthcare professional. Do not administer as slow intravenous injection or as intravenous bolus injection.

• Prior to administration, visually inspect the solution to confirm the absence of particles.

• Infuse the total volume of 125 ml of diluted medication over 1 hour using a 0.2 µm filter. Administer the entire solution. After administration of the product, flush the line with sodium chloride 9 mg/ml (0.9%) solution for injection.

• The product should be administered immediately after dilution, and the infusion of the diluted solution should be completed 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 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 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 should not be heated by any method other than ambient air.

• If infusion reactions occur, the infusion should be administered at a slower rate, interrupted, or discontinued.

• Do not inject other medications into the side ports of the infusion line or mix with Vyvgart.

4. Special handling and storage conditions

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

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date is the last day of the month indicated.