Vyvgart 1,000 mg solution for injection in pre-filled syringe: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vyvgart 1 000 mg solution for injection in pre-filled syringe

efgartigimod alfa

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

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask 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, because it may harm them.
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

What Vyvgart is and what it is used for
What you need to know before using Vyvgart
How to use Vyvgart
Possible side effects
How to store Vyvgart
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 immunoglobulin G (IgG) autoantibodies, which are immune system proteins that mistakenly attack parts of a person's own 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 in the nerves called acetylcholine receptors. Due to this damage, nerves are unable to properly stimulate muscle contraction, resulting in 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 disease symptoms 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, primarily in the legs and arms. Vyvgart may protect nerves from immune attacks 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 natural resistance to infections. Inform your doctor if you have any infection before starting Vyvgart.

Injection 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 making it difficult to swallow or breathe, shortness of breath, feeling faint, or skin rash during or after the injection, inform your doctor immediately.

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 may 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 the ability to drive or use machines.

Vyvgart contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per syringe; this is essentially “sodium-free”.

Vyvgart contains polysorbate

This medicine contains 2.1 mg of polysorbate 80 in each syringe, equivalent to 0.4 mg/ml. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How to use Vyvgart

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

What dose of Vyvgart you will receive and how often

Generalized myasthenia gravis

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

If you are already being treated with intravenous Vyvgart and wish to switch to subcutaneous Vyvgart, you should receive the subcutaneous injection instead of your intravenous infusion at the beginning of your next treatment cycle.

Chronic inflammatory demyelinating polyneuropathy

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

Vyvgart injection

Vyvgart is administered by injection under the skin (subcutaneously). You and your doctor should decide whether, after proper training, you or your caregiver can inject Vyvgart. The first self-injection must be performed under the supervision of a healthcare professional. It is important that you do not attempt to inject Vyvgart before receiving training from a healthcare professional.

If you or your caregiver will be injecting Vyvgart, you or your caregiver must carefully read and follow the Instructions for Use at the end of this leaflet (see “Important Instructions for Use”). Speak with your doctor, pharmacist, or nurse if you have any questions about how to administer an injection.

If you use more Vyvgart than you should

Since Vyvgart is administered in a single-use vial, it is unlikely that you will receive too much. However, if you are concerned, contact your doctor, pharmacist, or nurse for advice.

If you missed or forgot an appointment to receive Vyvgart

Keep a record of your next dose. It is important that you use Vyvgart exactly as prescribed by your doctor.

If you missed your dose within three days of the scheduled date, take your dose as soon as you remember, then continue with your original dosing schedule.
If you missed your dose for more than three days, ask your doctor when you should take your next dose.
If you missed an appointment, contact your doctor immediately for advice.

Do not take a double dose to make up for missed doses.

If you stop using Vyvgart

Stopping or discontinuing treatment with Vyvgart may cause your symptoms to return. Consult your doctor before stopping 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, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

Your doctor will explain the possible adverse 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 skin rash during or after the injection.

If you are unsure about which adverse effects are 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)
Reactions at the injection site, which may include redness, itching, pain. These injection site reactions are usually mild to moderate and typically occur one day after the injection.

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)
Nausea.

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

Allergic reactions during or after the injection.
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 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 leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Vyvgart Storage Instructions

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.

The unopened pre-filled syringe may also be stored at room temperature, in the original carton, not exceeding 30 °C, for a single period of up to 1 month after removal from the refrigerator. If not used within this 1-month period, or upon reaching the expiry date, whichever occurs first, the syringe must be discarded.

Keep in the original packaging to protect from light.

Do not use this medicine if particles are observed.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Vyvgart

The active substance is efgartigimod alfa. Each pre-filled syringe contains 1,000 mg of efgartigimod alfa in 5.0 ml. Each ml contains 200 mg of efgartigimod alfa.
The other components are: recombinant human hyaluronidase (rHuPH20), L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride monohydrate, L-methionine, polysorbate 80 (E433), sodium chloride, sucrose, water for injections. See section 2 “Vyvgart contains sodium”.

Nature of the product and pack contents

Vyvgart is a ready-to-use solution, slightly yellow, clear to slightly turbid, supplied as a subcutaneous injectable solution in a pre-filled syringe.

Marketing Authorisation Holder and Manufacturer Responsible

argenx BV
Industriepark-Zwijnaarde 7
9052 Gent
Belgium

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Belgium/Belgium/Belgien

argenx BV

Tel/Tel: +32 (0) 93969394/+32 (0) 800 54477