Watch how VYVGART for intravenous (IV) infusion works

Learn how VYVGART for IV infusion, a first-of-its-kind treatment, works in the body of adults with anti-AChR antibody positive generalized myasthenia gravis (gMG).

AChR=acetylcholine receptor; IV=intravenous

VYVGART Hytrulo for subcutaneous injection works in a similar way to VYVGART for IV infusion once in your body

VYVGART Hytrulo for subcutaneous injection contains 2 active ingredients: efgartigimod alfa, which is the same active ingredient in VYVGART for IV infusion, and hyaluronidase (human recombinant). Hyaluronidase helps to increase the distribution and absorption of ingredients into the body.

The body has many “characters” that influence how your muscles and brain work together to help you move. Expand below to learn more about some of the characters that play a role in the VYVGART treatment journey.

ACh

Acetylcholine (ACh) helps carry messages from the brain to different parts of the body, including muscles.

AChR

Acetylcholine receptor (AChR) is a type of receptor (message receiver) found in muscles. These receptors receive messages from nerves that tell muscles what to do.

IgG

Immunoglobulin G (IgG) antibody is a Y-shaped protein made by the immune system. Antibodies—like IgG—play a vital role in helping protect your body from infection and disease.

Harmful AChR antibody

Harmful acetylcholine receptor (AChR) antibodies disrupt communication between muscles and nerves.

FcRn

Neonatal Fc receptor (FcRn) is a receptor that attaches to IgG antibodies and helps IgG antibodies stay in the body longer.

Pictured: FcRn (yellow) with IgG antibody attached (green).

VYVGART is the first FDA-approved treatment that uses a fragment of an IgG antibody to treat adults with anti-AChR antibody positive gMG

IgG=immunoglobulin G

Antibody

Fragment

VYVGART is a fragment of an IgG antibody.

VYVGART is specifically designed to attach to and block the neonatal Fc receptor (FcRn), resulting in the reduction of IgG antibodies, including the harmful AChR antibodies that cause gMG symptoms

Receptors called “FcRn” extend the life of IgG antibodies.

In gMG, this allows harmful AChR antibodies to continue causing gMG symptoms. But IgG antibodies, including harmful AChR antibodies, that cannot attach to an FcRn are removed by the body.

When harmful AChR antibodies that cause gMG symptoms are removed, they can no longer disrupt nerve-muscle communication.

In the study, patients on VYVGART for IV infusion who had anti-AChR antibody positive gMG saw a reduction in total IgG antibody levels, which included a reduction in the levels of harmful AChR antibodies that cause gMG symptoms

VYVGART for IV infusion has a demonstrated safety profile.

Of the 84 patients in the study treated with VYVGART for IV infusion compared to the 83 patients on placebo, the most common side effects included respiratory tract infection (33% vs. 29%), headache (32% vs. 29%), urinary tract infection (10% vs. 5%), tingling sensation (7% vs. 5%), and muscle pain (6% vs. 1%).^a Most infections in patients on VYVGART for IV infusion were mild to moderate. Additionally, more patients on VYVGART for IV infusion vs. placebo had lower white blood cell counts that were mild to moderate in severity. Hypersensitivity reactions including rash, swelling under the skin, and shortness of breath were observed in some VYVGART for IV infusion-treated patients.

^aIn ≥5% treated with VYVGART for IV infusion and more frequently than placebo.

In the VYVGART Hytrulo study, VYVGART Hytrulo for subcutaneous injection had a similar reduction in the harmful AChR antibodies that cause gMG symptoms as VYVGART for IV infusion

The overall safety of VYVGART Hytrulo for subcutaneous injection was consistent with the safety profile of VYVGART for IV infusion, except patients on VYVGART Hytrulo for subcutaneous injection experienced more injection site reactions.

In the VYVGART Hytrulo study, the most common side effects of VYVGART Hytrulo-treated patients were injection site reactions, 38% (21 of 55), and headache. Injection site reactions included injection site rash, redness of the skin, itching sensation, bruising, pain, and hives.

In the VYVGART Hytrulo study and its long-term safety study:

All injection site reactions were mild to moderate and didn’t lead to treatment discontinuation
The majority of injection site reactions occurred within 24 hours of injection and resolved on their own
The majority of injection site reactions occurred during the first treatment cycle and decreased with each subsequent cycle

Hypersensitivity reactions including rash, swelling under the skin, shortness of breath, and hives were observed in some VYVGART Hytrulo-treated patients.

Be sure to discuss your symptoms and any side effects with your neurologist. Your neurologist will determine your next treatment cycle and this information can help.

VYVGART is available in 2 forms

For IV infusion—given by inserting a needle into a vein so the medicine enters the bloodstream.

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For subcutaneous injection—given by delivering medicine into the layer beneath the skin.

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Talk to your neurologist to see if VYVGART is right for you

The VYVGART Doctor Discussion Guide can be used to help you discuss with your neurologist current anti-AChR antibody positive gMG symptoms you have and how they impact your daily abilities.

GET DISCUSSION GUIDE

Getting started with VYVGART

Learn more at VYVGART (You)niversity

Watch a video, or attend a virtual or in-person event across the U.S. for an opportunity to learn more about VYVGART from an expert.

Find out more

VYVGART dosing

Your neurologist will work with you to help determine when you need another treatment cycle, with the aim to help manage your symptoms.^*

How dosing works

Frequently asked questions

Find answers to common questions about VYVGART treatment and support.

Get answers

*If additional cycles are needed.

Get the latest VYVGART updates

Still have questions? Call 1-833-VYVGART (1-833-898-4278) to speak with an educator about gMG, how VYVGART works, study data, cost and coverage, and more.

What is the most important information I should know about VYVGART^® (efgartigimod alfa-fcab) for intravenous (IV) infusion and VYVGART^® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. More patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and observed lower white blood cell counts were mild to moderate in severity. Your healthcare provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART or VYVGART HYTRULO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with VYVGART or VYVGART HYTRULO such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. If a serious infection occurs, your doctor will treat your infection and may even stop your VYVGART or VYVGART HYTRULO treatment until the infection has resolved.
Undesirable immune reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to treatment discontinuation. Your healthcare provider should monitor you during and after treatment and discontinue VYVGART or VYVGART HYTRULO if needed. Tell your healthcare provider immediately about any undesirable reactions to VYVGART or VYVGART HYTRULO.

Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:

Have a history of infection or you think you have an infection.
Have received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO. The use of vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects of efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

What is VYVGART for IV infusion and what is VYVGART HYTRULO for subcutaneous injection?

VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about VYVGART^® (efgartigimod alfa-fcab) for intravenous (IV) infusion and VYVGART^® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. More patients on efgartigimod alfa-fcab vs placebo had below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts. The majority of infections and observed lower white blood cell counts were mild to moderate in severity. Your healthcare provider should check you for infections before starting treatment, during treatment, and after treatment with VYVGART or VYVGART HYTRULO. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with VYVGART or VYVGART HYTRULO such as fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. If a serious infection occurs, your doctor will treat your infection and may even stop your VYVGART or VYVGART HYTRULO treatment until the infection has resolved.
Undesirable immune reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause the immune system to have undesirable reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. In clinical studies, the reactions were mild or moderate and occurred within 1 hour to 3 weeks of administration, and the reactions did not lead to treatment discontinuation. Your healthcare provider should monitor you during and after treatment and discontinue VYVGART or VYVGART HYTRULO if needed. Tell your healthcare provider immediately about any undesirable reactions to VYVGART or VYVGART HYTRULO.

Before taking VYVGART or VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:

Have a history of infection or you think you have an infection.
Have received or are scheduled to receive a vaccine (immunization). Discuss with your healthcare provider whether you need to receive age-appropriate immunizations before initiation of a new treatment cycle with VYVGART or VYVGART HYTRULO. The use of vaccines during treatment with VYVGART or VYVGART HYTRULO has not been studied, and the safety with live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with VYVGART or VYVGART HYTRULO.
Are pregnant or plan to become pregnant and are breastfeeding or plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects of efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

What is VYVGART for IV infusion and what is VYVGART HYTRULO for subcutaneous injection?

VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.

Questions? Call 1-833-VYVGART
(1-833-898-4278)

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VYVGART is a registered trademark of argenx.
VYVGART Hytrulo is a trademark of argenx.

For U.S. audiences only.

US-VYV-23-00228 V3 11/2023

For adults with anti-AChR antibody positive generalized myasthenia gravis (gMG)