VYVGART is a
first-of-its-kind
treatment

See the science behind how VYVGART works in the body.

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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

Y-graphic-LG
Group 2

Fragment

VYVGART is a fragment of an IgG antibody.

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. VYVGART for IV infusion may increase the risk of allergic reactions including rash, swelling under the skin, and shortness of breath. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.

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

VYVGART Hytrulo may increase the risk of allergic reactions including rash, swelling under the skin, shortness of breath, and hives. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.

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.


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

  

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.

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.

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.*

Frequently asked questions

Find answers to common questions about VYVGART treatment and support.

*If additional cycles are needed.

Get the latest VYVGART updates

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VYVGART (efgartigimod alfa-fcab) Injection for Intravenous Use 400 mg/20 mL vial; VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Subcutaneous Injection 180 mg/mL and 2000 U/mL vial
VYVGART (efgartigimod alfa-fcab) Injection for Intravenous Use 400 mg/20 mL vial; VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Subcutaneous Injection 180 mg/mL and 2000 U/mL vial

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.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

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. Signs or symptoms of an infection may include 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.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

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

The most common side effects in 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® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) 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.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

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. Signs or symptoms of an infection may include 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.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

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

The most common side effects in 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® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) 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.