Prospect: information for the patient

Vyvgart 1 000 mg injectable 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 how 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 immunoglobulin G (IgG), which are proteins of the immune system that attack parts of the body of a person by mistake.

What is Vyvgart used for

Vyvgart is used in combination with the 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.

Do not 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

Treatment with Vyvgart may reduce your natural resistance to infections, so inform your doctor if you have any infections before starting to use 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 anaphylactic reaction (severe allergic reaction). If you experience allergic reactions such as facial swelling, lip, throat, or tongue swelling that makes it difficult to swallow or breathe, shortness of breath, feeling of loss of consciousness, or skin rash during or after theinjection, inform your doctor immediately.

Vaccinations (vaccines)

Inform your doctor if you have received 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 effect is expected on the ability to drive or operate machines.

Vyvgart contains sodium

This medication contains less than 1mmol of sodium (23mg) per vial; essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

What dose of Vyvgart you will receive and how often

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

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

Injection of Vyvgart

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

If you or your caregiver administer Vyvgart, you or your caregiver must carefully read and follow the Administration Instructions that appear at the end of this leaflet (see "Important Use Instructions"). Discuss any doubts you have about administering an injection with your doctor, pharmacist, or nurse.

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 a scheduled appointment to receive Vyvgart

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

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

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Vyvgart

Discontinuing or stopping treatment with Vyvgart may cause your MG symptoms to recur. Consult with your doctor before interrupting treatment with Vyvgart. Your doctor will explain the possible adverse effects and risks. Your doctor will also closely monitor you.

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

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

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

Inform your doctor immediately if you notice:

Signs of a severe allergic reaction (anaphylaxis) 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 injection.

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 10patients)

• Upper respiratory tract infections (nasopharyngitis)
• Reactions at the injection site, which may include redness, itching, pain. These reactions at the injection site are usually mild to moderate and usually appear one day after the injection.

Common(may affect up to 1 in 10patients)

• 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)

Unknown Frequency(cannot be estimated from available data)

• Allergic reactions during or after the injection.

• 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 thenational notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of thismedicine.

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.

In case of need, unopened vials can be stored at room temperature (up to 30°C) for a maximum of 3 days. After storage at room temperature, unopened vials can be returned to the refrigerator. The total time outside the refrigerator and at room temperature should not exceed 3 days.

Store in the original packaging to protect it from light.

Do not use this medication if you observe particles.

Medicines should not be thrown into the drains or trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. In this way, you will help to protect the environment.

Composition of Vyvgart

• The active ingredient is efgartigimod alfa. Each vial contains 1,000 mg of efgartigimod alfa in 5.6 ml. Each ml contains 180 mg of efgartigimod alfa.
• The other components are: human recombinant hyaluronidase (rHuPH20), L-histidine, L-histidine hydrochloride monohydrate, L-methionine, polysorbate 20, sodium chloride, sucrose, water for injection. See section "Vyvgart contains sodium".

Appearance of the product and contents of the package

Vyvgart is a ready-to-use solution, slightly yellow, transparent to slightly turbid, which is presented as a subcutaneous injectable solution.

Holder of the marketing authorization and responsible for manufacturing

argenx BV

Industriepark-Zwijnaarde 7

9052 Gent

Belgium

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

Last review date of this leaflet

Other sources of information

The detailed information about this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu/ . There are also links to other websites about rare diseases and orphan medicines.

Important use instructions

Vyvgart 1,000 mg solution for injection

efgartigimod alfa

Subcutaneous route

Read and understand these use instructions before administering the Vyvgart injection.

If you or your caregiver are willing to administer Vyvgart, your healthcare professional will instruct you on how to inject it. Your healthcare professional should teach you or your caregiver how to properly prepare and administer the Vyvgart injection before using it for the first time. A suitable self-administration demonstration under the supervision of a healthcare professional is required. It is essential that you do not attempt to inject the medication until you have received training and you or your caregiver are confident that you know how to use Vyvgart. Ask your healthcare professional if you have any questions.

Important information you should know before administering a subcutaneous injection of Vyvgart.

• Only for subcutaneous use.
• The vial is for single use only. Do not store the vials, even if they are not empty. Do not use a vial if you observe unusual turbidity or visible particles. The medicine must have a slightly yellow appearance, transparent to slightly turbid.
• Do not shake the vial during handling.
• Do not use vials that are damaged or without a protective cap. Notify and return the damaged or capless vials to the pharmacy.

Storage of Vyvgart

• Store in the refrigerator (between 2°C and 8°C).
• Do not freeze.
• If necessary, the vials without opening can be stored at room temperature (up to 30°C) for a maximum of 3 days. After storage at room temperature, the vials without opening can be returned to the refrigerator. The total time outside the refrigerator and at room temperature should not exceed 3 days.
• Store in the original packaging to protect it from light.
• Keep this medicine out of the sight and reach of children.

Preparation of the material

Step 1 Remove the vial box from the refrigerator.
Step 2 Remove the vial from the box and check that: The vial is not cracked, broken, missing the protective cap, or showing any signs of damage. The expiration date has not passed. If either of the above conditions is not met, do not administer the injection and inform the pharmacy.
Step 3 Wait at least 15 minutes for the vial to come to room temperature naturally. Check if the medicine in the vial is slightly yellow, transparent to slightly turbid, and does not contain visible particles. Do not attempt to heat the vial in any way other than leaving it at room temperature. Do not shake the vial.
Step 4 Gather the following additional materials: 2 alcohol wipes 1 10 ml syringe 1 transfer needle, calibre 18 1 microperfusion device, calibre 25 x 30 cm 1 sterile gas 1 adhesive patch 1 sharp object container (see step 28)
Step 5 5a. Clean the work area. 5b. Wash your hands with soap and dry them well.
Preparation of the syringe
Step 6 Remove the removable plastic cap from the vial. The aluminum cap should remain in place.
Step 7 Clean the rubber stopper with a new alcohol wipe. Allow it to air dry naturally for at least 30 seconds. Do not suck on the rubber stopper.
Step 8 Unfold the syringe and the transfer needle. Insert the transfer needle into the syringe and turn it clockwise until the needle is firmly attached to the syringe. Do not touch the tip of the syringe or the lower part of the needle to avoid germs and the risk of infection.
Step 9 Pull the plunger slowly to introduce 7 ml of air into the syringe.
Step 10 10a. Hold the syringe by the cone where the needle is attached to the syringe. 10b. Hold the needle cap and pull it out carefully from the body. 10c. Place the needle cap downwards on a clean and flat surface. Do not pull the cap. It should be put back and removed from the needle after use. Maintain the needle sterile: Do not touch the needle or its tip. Do not place it on a surface once the needle cap has been removed.
Step 11 Hold the vial in a vertical position on a flat surface and insert the transfer needle through the center of the rubber stopper that has been disinfected. Do not perforate the rubber stopper of the vial more than once to avoid leaks.
Step 12 Turn the vial while keeping the transfer needle inserted in it.
Step 13 13a. Ensure that the transfer needle of the vial points upwards with the tip of the needle above the solution of the medicine. 13b. Push the plunger gently to inject all the air from the syringe into the empty space above the solution of the medicine in the vial. 13c. Keep your finger pressed on the plunger of the syringe. Do not inject air into the solution of the medicine, as it may create air bubbles or foam.
Step 14 Fill the syringe as follows: 14a. Keep your finger pressed on the plunger and slide the tip of the transfer needle into the solution of the medicine in the neck of the vial (near the vial cap) so that the tip of the needle is completely covered in the solution. 14b. Withdraw the plunger slowly while keeping the tip of the transfer needle in the solution to avoid air bubbles and foam in the syringe. Fill the syringe with all the contents of the vial.
Step 15 Eliminate large air bubbles, if any. 15a. Keep the transfer needle in the vial and check if there are large air bubbles in the syringe. 15b. Eliminate large air bubbles by gently tapping the syringe with your fingers until the bubbles rise to the top of the syringe. 15c. Move the tip of the transfer needle over the solution of the medicine and push the plunger slowly upwards to expel the air bubbles from the syringe. 15d. To eliminate any remaining solution of the medicine from the vial, insert the tip of the transfer needle into the solution and pull the plunger slowly until all the contents of the vial are in the syringe. 15e. Repeat the above steps until all large air bubbles have been eliminated. If you cannot extract all the liquid from the vial, place it in a vertical position to reach the remaining amount.
Step 16 16a. Turn the vial in a vertical position and remove the syringe and transfer needle from the vial. 16b. With one hand, slide the transfer needle into the cap and lift it to cover the needle. 16c. Once the needle is covered, screw the cap onto the syringe to secure it completely.
Step 17 17a. Pull the transfer needle out and turn it counterclockwise to remove it from the syringe. 17b. Dispose of Страна регистрации Испания Активное вещество Efgartigimod alfa Требуется рецепт Да Производитель Argenx B.V. Состав Cloruro de sodio (32,20 mg mg), Sacarosa (113,90 mg mg) Информация носит справочный характер и не является медицинской рекомендацией. Перед приёмом любых препаратов проконсультируйтесь с врачом. Oladoctor не несёт ответственности за медицинские решения, принятые на основе этого контента. Общайтесь с врачом онлайн Есть вопросы по этому лекарству или вашим симптомам? Свяжитесь с лицензированным врачом для получения помощи и персонализированного ухода. 5.01 отзыв Анна Морет Дерматология18 лет опыта Анна Морет — врач-дерматолог и дерматовенеролог с международной сертификацией. Специализируется на дерматологии взрослых и детей, венерологии, эстетическом уходе за кожей и общей медицине. Проводит онлайн-консультации, опираясь на доказательную медицину и индивидуальные потребности каждого пациента. Сфера помощи включает: • кожные заболевания: экзема, акне, розацеа, дерматиты, псориаз • проблемы с волосами и кожей головы: выпадение волос, перхоть, себорейный дерматит • детская дерматология — от новорождённых до подростков • венерология и ЗППП (заболевания, передающиеся половым путём) • эстетические запросы: возрастные изменения кожи, неинвазивные косметологические процедуры • аллергические реакции и повышенная чувствительность кожи • проверка родинок, оценка новообразований, скрининг рака кожи • рекомендации по уходу за кожей и подбор индивидуальной космецевтики Объединяя дерматологию с клиническим опытом в общей медицине, Анна Морет оказывает комплексную помощь, охватывая не только состояние кожи, но и сопутствующие проблемы со здоровьем. Имеет сертификацию Канадского совета эстетической медицины, что подтверждает международный уровень подготовки в сфере эстетической дерматологии. Записаться на онлайн-консультацию Больше времени 5.01 отзыв Алина Цуркан Семейная медицина12 лет опыта Алина Цуркан — лицензированный врач семейной медицины в Португалии. Проводит онлайн-консультации для взрослых и детей, помогая пациентам решать широкий круг повседневных медицинских вопросов с профессиональным подходом и вниманием к деталям. Обращаться можно по следующим поводам: • респираторные инфекции: простуда, грипп, бронхит, пневмония • глазные заболевания: конъюнктивит (инфекционный и аллергический) • ЛОР-заболевания: синусит, отит, тонзиллит • проблемы с пищеварением: гастрит, кислотный рефлюкс, синдром раздражённого кишечника (СРК) • инфекции мочевыводящих путей и другие распространённые инфекции • хронические заболевания: артериальная гипертензия, диабет, нарушения работы щитовидной железы • головная боль и мигрень Помимо лечения симптомов, Алина Цуркан уделяет особое внимание профилактике и раннему выявлению заболеваний. Проводит плановые осмотры, даёт медицинские рекомендации, проводит повторные консультации и выписывает рецепты — с учётом индивидуальных потребностей каждого пациента. Её подход — комплексный, внимательный и адаптированный к каждому этапу жизни пациента: от острых состояний до долгосрочного контроля здоровья. Записаться на онлайн-консультацию Больше времени 5.09 отзывов Андрей Попов Терапия6 лет опыта Андрей Попов — лицензированный в Испании терапевт и специалист по лечению боли. Проводит онлайн-консультации для взрослых, помогая справляться как с хронической, так и с острой болью, а также с широким кругом общетерапевтических запросов. Специализируется на диагностике и лечении болевых состояний, продолжающихся более 3 месяцев или существенно влияющих на повседневную активность. Работает со следующими жалобами: • хроническая боль любого происхождения • мигрени и повторяющиеся головные боли • боли в шее, спине, пояснице и суставах • посттравматическая боль (после травм, растяжений, операций) • невропатическая боль, фибромиалгия, невралгии Помимо работы с болевыми синдромами, Андрей Попов помогает в ведении: • респираторных инфекций (ОРВИ, бронхит, пневмония) • артериальной гипертензии и метаболических нарушений (включая диабет) • профилактических осмотров и общего контроля состояния здоровья Онлайн-консультация длится до 30 минут и включает разбор симптомов, рекомендации по обследованиям, формирование плана лечения и дальнейшее сопровождение при необходимости. Андрей Попов придерживается принципов доказательной медицины и предлагает индивидуальный подход с учётом симптомов, истории болезни и образа жизни каждого пациента. Записаться на онлайн-консультацию Больше времени 5.01 отзыв Евгений Яковенко Общая хирургия11 лет опыта Евгений Яковенко — лицензированный хирург и терапевт в Испании. Специализируется на общей и детской хирургии, внутренней медицине и лечении боли. Проводит онлайн-консультации для взрослых и детей, сочетая хирургическую практику с терапевтическим сопровождением. Сфера медицинской помощи включает: • диагностику и лечение острой и хронической боли • пред- и послеоперационное ведение, оценку рисков, контроль состояния • хирургические заболевания: грыжи, желчнокаменная болезнь, аппендицит • консультации по детской хирургии: врождённые состояния, малые вмешательства • травмы: переломы, повреждения мягких тканей, обработка ран • онкохирургия: консультации, планирование, ведение после лечения • внутренние заболевания: патологии сердечно-сосудистой и дыхательной систем • ортопедические состояния, реабилитация после травм • интерпретация результатов визуализации для хирургического планирования Евгений Яковенко активно занимается научной деятельностью и международным сотрудничеством. Член Ассоциации хирургов Германии (BDC), сотрудничает с Ассоциацией семейных врачей Лас-Пальмаса и Генеральным консульством Германии на Канарских островах. Регулярно участвует в международных медицинских конференциях и публикует научные статьи. Объединяя многопрофильный опыт с принципами доказательной медицины, он оказывает точную и индивидуализированную помощь пациентам с различными медицинскими запросами. Записаться на онлайн-консультацию Больше времени Смотреть всех врачей Следите за новостями и экономьте на услугах Советы врачей, обновления платформы и скидки для подписчиков. Подписаться Следите за нами в соцсетях УслугиВрачиПомощь Поиск