VYVGART 20 mg/mL concentrate for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Vyvgart is and what it is used for
2. What you need to know before you use Vyvgart
3. How to use Vyvgart
4. Possible side effects
5. How to store Vyvgart
6. Contents of the pack and other information

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.

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.

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

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.

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.

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

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

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.

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

This medicine contains 67.2 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.4% 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.

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 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, please contact your doctor immediately for advice and see section below “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 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 Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MRHA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is efgartigimod alfa.

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

The other ingredients are:

• sodium dihydrogen phosphate, monohydrate
• disodium hydrogen phosphate, anhydrous
• sodium chloride
• arginine hydrochloride
• polysorbate 80
• water for injections

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.